Figure 1 Our TauTrack Mission

The Critical Gap in Early Alzheimer's Diagnostics

Alzheimer’s is becoming more and more of a crisis, but the tools we have at our disposal for definitive, early diagnosis are woefully inadequate for patients and families as well as clinicians. This diagnostic void poses both tremendous and costly issues for our primary customers: neurology specialty clinics, memory disorder centers and pharmaceutical companies.

In such specialized clinics, for example in urban areas of the United States, Europe, Japan and China in which populations are relatively old (age is a primary risk factor to develop cancer), will be overburdened with patients demanding promising early diagnosis. In 2024, there are an estimated 6.9 million Americans age 65 and older living with Alzheimer's dementia, which means the centers need quicker and less invasive tools to diagnose their increasing patient load.

Pharmaceutical companies who are developing AD drugs in parallel, incentivized by recent FDA approvals of therapies such as Lecanemab, sit as a major secondary market. They urgently require efficient, scalable biomarkers to screen for ideal trial participants and track how well therapeutic interventions are working.

Today's clinical "gold standard" driven protocols that such customers must rely on are invasive, costly and unaatable for broad use.

The Insufficiency of Current Diagnostic Criteria

Cerebrospinal Fluid (CSF) Analysis: While it is possible to use CSF assays to measure AD biomarkers, the procedure requires a lumbar puncture (spinal tap) that is invasive and uncomfortable for patients as well as has 10%-30% probability of post-procedure headache, this hinders its applicability in routine screenings.

Positron Emission Tomography (PET) Scans: These scans could see AD pathology, but they are costly and typically cost $3,000–$6,000 per scan. This high price poses barriers to reimbursement and patient access, and the requirement of dedicated scanning facilities precludes its availability in many small clinics or developing countries.

Neuropsychological Testing: Traditional cognitive tests (e.g., Mini–Mental State Examination MMSE, Montreal Cognitive Assessment MoCA) are subjective, sensitive to education and examiner; and do not provide molecular level biomarker information.

Challenges of Current Blood Tests: While T-Tau measuring blood tests have emerged, and their levels have been found to lack correlation to definite CSF biomarkers and not to consistently differentiate between patients with AD from control individuals, these tests have limited clinical applicability.

Genetic Testing: this is relevant for very rare familial types of AD and not for the general majority of sporadic cases.

The severe shortcomings of these approaches leave a diagnostic vacuum, with devastating consequence to our addressable customers and health care system:

Late Diagnosis and Non-reversible Evolution: Patients are usually diagnosed late in the course of disease, when extensive neurodegeneration has already happened and cannot be reversed.

Obstacle to Early Intervention: This interval prevents patients from accessing therapies when they would be most efficacious in treating the disease, i.e., at the onset of symptoms.

Barriers to Pharmaceutical Research: With current diagnostics being extremely expensive and invasive, pharmaceutical companies are presented with an uphill struggle of finding and enrolling into clinical trials the large patient cohorts in earlier stages necessary for developing superior drugs.

Thus, there is a clear and unmet clinical need for a reliable diagnosis that is both non-invasive, inexpensive, and scalable. A disruptively accurate and specific tool that changes the diagnostic journey, empowering our target customers, rapidly screen across the population and intervene early, increasing the speed of change in therapeutic innovation

Figure 3 Diagram of our Technology

At the core of the TauTrack innovation is an advanced multi-step diagnostic system that addresses these core limitations in existing stages of AD diagnostics. Three independent and cooperative characteristics are responsible for the technology of our device: ultra-specific molecular recognition, powerful signal amplification, and a integrated microfluidic detection system.

Molecular Recognition (The Aptamer Probe): Our test is built upon a proprietary nucleic acid aptamer, which is an artificially created specific and strong ligand. Created using a highly complex in-vitro process called SELEX (Systematic Evolution of Ligands by Exponential Enrichment), our aptamer is developed to specifically attach only to brain-derived tau (BD-tau)—a primary AD biomarker—and not the thousands of other proteins present within a patient’s blood sample.(Please visit our Engineering page for details)

Signal Amplification (The CRISPR-Cas12a Engine): In order to maximize the sensitivity, we coupled the aptamer with CRISPR/Cas12a enzyme system. When our aptamer clasps its BD-tau target, it activates the potent “collateral cleavage” function of the Cas12a enzyme. This results in a fast enzymatic cascade which can increase the initial binding event thousands of times and results in a strong, readily detectably fluorescent signal even where the per se amount of biomarker is small.(Please visit our Engineering page for details)

Diagnostic Platform (Microfluidic Chip): The entire diagnostic process is incorporated into a single automated, low cost disposable "lab-on-a-chip" using integrated microfluidics. This approach provides fine control over the reaction, reduced sample and reagent consumption and final signal detection. In one embodiment, this method allows the process to be fast, reproducible and scalable.(Please visit our Hardware page for details)

In summary, TauTrack combines these three cutting-edge technologies to form one comprehensive diagnostic test. It turns a complex biological question into a simple, quantitative answer so we can now provide a solution that is both scientifically sophisticated and commercially attractive and clinically disruptive.

Total Addressable Market (TAM)

The AD diagnostic TAM is not only a commercial opportunity, but a global healthcare necessity. The size of the market, and its expected expansion, is a direct result of the intensifying global public health crisis that AD constitutes, especially in rapidly aging populations like China. This need for novel diagnostics is motivated by the high prevalence of affected individuals and enormous economic impact of the disease.

Key Market Insights & Opportunity

The insights are loud and clear from the very front-line of public health and epidemiological sources; a multibillion-dollar market set for stratospheric increases.

Huge and Increasing dementia Patient Population (Global & China): In the world, population of dementia patients is huge. Currently, over 55 million people are living with dementia globally and it is estimated that this figure will increase to 78 million by 2030 (World Health Organization, 2021). A substantial and increasingly large share of that burden is in China, which has the largest population of people with Alzheimer’s disease in the world. In 2020, it was estimated that there were over 15.07 million people in China aged 60 and older that had dementia (Jia et al., 2020). This makes China an important and fast growing portion of the addressable market.

Universal Economic Burden (Global & China): The total economic burden of dementia globally is monstrous. In 2019, the worldwide figure was estimated to be USD 1.3 trillion (World Health Organization, 2021). This number will grow significantly in the upcoming years. In China, the cost burden is also substantial; the total annual cost of caring for people with dementia reached USD 167.74 billion in 2015 (Jia et al., 2018). This underscores the international and national economic imperatives for early diagnostics that can facilitate prompt intervention and improved disease management, which is at the heart of the TAM value proposition.

Primary Growth Drivers

The main market drivers, presented in the literature are:

Aging Global Population: As demonstrated by a variety of the research, the borderless dementia epidemic particularly in crowded and increasingly elderly nations such as China is the greatest force creating a need for diagnostics."

Going from Paradigm Shift to Early Detection: There is an urgent clinical and research need for early (and accurate) diagnosis, which is a critical factor in improving patient outcomes but also important for new disease-modifying therapies.

Serviceable Available Market (SAM)

The Serveable Available Market (SAM) is the part of the Total Addressable Market (TAM) which can be reached by TauTrack considering both geographical, regulatory and customer constraints. We have prioritized markets which have well-defined regulatory pathways, good health care infrastructure and large patient populations.

Our SAM is biased by the limitations listed as follows:

Geographical Focus: We will do an initial entry into developed regions and leading high growth areas. Our main target markets are USA, EU, Japan, Canada.Australia and China due to its increasingly huge and aging population as well as the large size of its domestic health care market.

Regulatory Pathway: Our product is not currently approved for use. Hence, in the SAM, there are those markets we will seek for and acquire certification such as NMPA (China), FDA (U.S.), and CE marking (EU).

Target Markets: Our dominant target market is B2B- professional medical organization. A DTC channel is another possible future growth opportunity and has been omitted in the base SAM.

To narrow down the target market selection out of this large TAM, we adopted a strategic analysis framework rooted on three main dimensions: Size (number of reachable customers), Potential (economic value and capacity to spend on health) and Access (ease with which entering into that market can be achieved. Each contribution was rescaled and weighted so as to yield a relative score for our key regions of interest.

Table 1 | SPA-Canvas for TauTrack's Primary Markets

Region	Size (Targetable Users)	Size Scaled (1x)	Potential Scaled (5x)	Access Scaled (3x)	Weighted Score
China	32.6 Million	10	7	6	8.3
North America	9.4 Million	3	10	8	8.3
Europe	16.5 Million	5	8	8	7.9
Japan	5.4 Million	2	7	7	6.4
Canada	1.0 Million	1	8	7	6.2
Australia	0.6 Million	1	8	7	6.2

Scaling: Size is scaled relative to the largest market (China). Potential and Access are scored 1-10 based on market maturity, healthcare spending, and regulatory complexity.

Weighted Score Calculation: (Size x 1) + (Potential x 5) + (Access x 3) / 9

In this SPA-canvas, we can see that China and North America are the markets with the greatest combined score for size, potential and access. These are the two areas on which we will be focusing most in our midterm strategy. Thus, our Serviceable Available Market (SAM) is the total revenue opportunity for these high-end markets.

Serviceable Obtainable Market (SOM)

Although we have a large medium-term SAM, our direct Go-to-Market plan needs to be very much razor-focused in order to get the best possible launch and iteration speed. As our key team members are from China, we have a unique “home court” advantage with deep knowledge of the local healthcare market, professional networks, and direct access to understanding NMPA regulations.

Thus, we will concentrate our early efforts only on the Early AD diagnostic device market in China.

China’s ageing population is becoming increasingly significant, and the focus from government on healthcare innovation also means it’s a good time to be an entrepreneur. We will focus on hospitals in Tier 1 and Tier 2 cities, with existing departments of neurology and a large number of patients at risk. Through full resource focus, we will have a standing beachhead, can create brand awareness and gain critical realworld data before going international.

Segmentation, Target and Positioning (STP)

Having identified who we will sell to in the SAM/SOM analysis, our STP strategy defines which specific customers segments we are targeting, where your go-to-market resource focus is placed and the basis of differentiation amongst the competition.

Figure 4 STP Analysis

Market Segmentation

We are dividing the early Alzheimer's diagnosis market by geography, institution and need-based criteria to determine which customer groups are most receptive.

A) Geographic Segmentation:

We are primarily looking into target countries (China, North America, and Europe etc.) big cities. We primarily focus on tier-1 and tier-2 cities, such as Beijing, Shanghai, Guangzhou and Shenzhen. These regions are characterized by:

• Higher healthcare spending in developed economies.
• Concentrations of specialized medical infrastructure.
• Greater disposable incomes and increasingly health-aware populations.

B) Institutional & Needs-Based Segmentation:

We segment our B2B customers according to their particular operating needs and those of the patient populations they serve.

Segment 1: Specialized Diagnostic Units (eg Hospital Neurology Departments, Memory Clinics)

Key Requirement: High-Accuracy & Professional Translation. These customers are influencers and since they need definitive diagnosis have needed the most accurate / reliable data.’ Cost is a far second to clinical soundness and the ability to provide services that are on the forward edge.

Segment 2: Providers that Conduct High-Volume Screening Indirectly (Third-party Physical Examination Agencies, etc.)

Primary Need: Efficiency & Cost-Effectiveness. For these customers, it is low cost, fast results turn-around and ease of operation for high flow of patients tested on a routine healthcare screen-and-confirm test.

Segment 3: Nursing homes

Primary Need: Safety & Simplicity. This population needs a minimally invasive, patient-safe diagnostic for kind-of monitoring or first screening.

Market Targeting

According to our segmentation study, we will implement a staggered approach to achieve an effective and strategic market entry.

Target Market Primary: Initially and primarily, we will be targeting Segment 1: Specialty Diagnostic Centers (Hospitals and Memory Clinics).

Why it matters: This area is the superhighway of Alzheimer's diagnosis and therapy. Winning their confidence and uptake will validate our technology, give it clinical credibility, and provide a strong 'pull' on the rest of the market. They are also the cohort that is feeling the pain points most sharply — of costly PET scans and painful CSF tests.

After successfully conquering segment 1, we will consequently proceed to a penetration of the primary target market, our expansion plans include entering Segment 2 (Third-party examination institutioris) and Segment 3 (Nursing homes).

Rationale: These segments have a bigger market potential and our product's affordability and ease of use can be distinguishing factors.

Market Positioning

TauTrack will pique interest as the most rapid, accurate and cost-effective blood-based detection of Alzheimer’s disease—providing critical molecular information for clinicians while eliminating the high costs and invasive nature of current protocols.

The foundation of our positioning rests on three primary pillars of competitive differentiation:

A) Cost-Effectiveness & Accessibility:

The main obstacle for early AD detection today is financial cost. PET scans in China, which can range between 7,000 to 10,000 RMB ($1-$1.4k USD), is an amount that most would consider a non-option for the average family given Chinese national averages of disposable income. Our test will be inexpensive compared to the cost of whole genome sequencing, so it could be used for population screening and really democratize early diagnosis.

B) Safety & Minimal Invasiveness:

The present "gold standard," CSF sampling, is highly invasive and associated with discomfort, headaches, and rare but severe adverse events. Ours, on the other hand, only needs a straight forward venous blood sample. The process is a routine one, relatively painless and with almost no side effects. This substantial reduction in invasiveness and risk eliminates a strong disincentive to patient compliance, and enables serial testing. (Our R&D roadmap includes the realisation of a fingertip blood draw method that will add even more convenience).

C) Speed & Efficiency:

Current diagnostic routes that involve PET scans or testing of the CSF can require days, sometimes weeks, to return a result. This procedure is time consuming, cumbersome and anxiety-producing to the patient. Our microfluidic system is intended to provide a quantitative result within minutes, not days. This dramatic speed enhancement allows new clinical decisions to be performed rapidly, reduces patient waiting times and increases the overall efficiency and throughput of diagnostic clinics.

Figure 5 SEEPLE Analysis

This STEEPLE (Social, Technological, Economic, Environmental, Political, Legal and Ethical) analysis will define the principal macro-environmental factors which influence TauTrack's success potential. It is a detailed view of what we can seize and what we still need to overcome.

Social Factors

Two mega-trends have converged in recent years to really fuel our mission.

• Opportunity | A World Where People Are Growing Old Fast: The world’s population of people 65 and older is growing so fast that by 2030 it will exceed the number of young people. Age is the No. 1 risk factor for Alzheimer's, so this demographic change "is what has made the (Alzheimer's) market." It means a huge and growing customer base for an efficient early diagnostic tool like TauTrack for decades to come.
• Opportunity | Increased Public Awareness and Active Health Care: Most medical campaigns and media coverages have enabled people to become more informed about Alzheimer’s disease. This greater awareness is changing people’s thinking about their brain health and being more proactive and getting tested earlier. This generates high market demand for convenient and non-invasive tools such as ours.
• Threat | The Social Stigma of an Alzheimer's Diagnosis: Despite increased awareness, a stigma surrounding an Alzheimer's diagnosis continues to exist at unacceptable levels, and this prevents people from getting the help they need. This can pose a significant impediment for testing. Our minimally invasive, private blood test is uniquely positioned to reduce this psychological barrier, making it less daunting for people to take the leap of getting a diagnosis than with procedures such as lumbar puncture.

Technological Factors

Our business is science-based, which is a double-edged sword: it’s a competitive advantage, but we’re always working hard to stay far ahead and never feel like we made it.

• Opportunity | Validated Biomarker and Innovative Platform: Our technology has solid scientific underpinning. The assay is based on brain-derived tau (BD-tau), a biomarker that has been clinically demonstrated to be extremely specific to Alzheimer’s-related neurodegeneration. The application of an aptamer-CRISPR-Cas12a-microfluidics technological map enabled us to obtain a competitive sensitivity, accuracy and economy over the classical method here.
• Opportunity | Emergence of digital health and tele-medicine: There is a huge opportunity from the global swing toward digital healthcare. We intend to build our diagnostic system so that it can easily be incorporated into electronic health records (EHRs) and tele-health systems. This will simplify clinicians'€™ workflow, improve patient access in rural areas, and enable superior data-driven health care.
• Threat | Fast-Moving and Competitive Innovation Environment: The industry for blood-based markers for Alzheimer's disease is fast-moving and competitive. Well before our technology can even demonstrate that it can be better (or even cheaper) than current standards like costly PET scans, it must leapfrog over potential competing technologies based on blood tests. It calls for a dedication to constant R&D to keep TauTrack ahead of the game.

Economic Factors

The financial landscape is ripe for a solution that provides clinical and economic value.

• Opportunity | A Large, Rapidly Growing Market: The worldwide market for Alzheimer’s diagnostics is already valued at billions of dollars and could grow substantially. This expansion is driven by the growing incidence of the disease, and a trend towards early diagnosis creates a considerable commercial opportunity for TauTrack.
• Opportunity | Imperative to Lower Healthcare Costs: Alzheimer’s disease represents an enormous financial burden on healthcare organizations and families, with annual long-term care costs reaching hundreds of billions per year. Early diagnosis allows early intervention and planning Our inexpensive test can lead directly to significant long-term savings for health insurers, systems and families. This is what makes our product a very compelling value proposition.
• Threat | High Requirements for Capital Development: It requires a significant investment to take an idea from the research stage to market as a medical tool. We have the expense of needing to perform large clinical trials, scale manufacturing and go through global regulatory submissions. Being able to raise sufficient financing in the form of grants, venture capital or strategic partnerships is critical and a challenge that must be actively addressed.

Environmental Factors

Our business plan must be to protect the environment we enjoy.

• Compliance | Biohazard Material Management: Our used diagnostic probes and our reagents will be considered biohazard waste simply because it is a medical device. The collection, handling and disposal of CDs is also heavily regulated by very specific environment laws such as those required by EPA in USA and similar ones for Europe. This necessitates the formulation and compliant coding of clear protocols from the beginning.
• Opportunity | Corporate Responsibility via Sustainability: Corporate responsibility for the environment is on the rise. If we get out in front now by planning for sustainable manufacturing, waste minimization, and a viable recycling or disposal plan for our device components, not only will we comply with regulations, but we can also establish a positive corporate reputation as an environmentally friendly entity.

Political Factors

The political picture offers a mix of support from government and the sort of regulatory obstacles that every fledgling company seeks to avoid.

Opportunity | Massive Government Support and Supportive Policies: All the governments from the globe are standing together to fight against the Alzheimer's problem. This has resulted in significant research and development investment from organizations such as the National Health Commission of PRC, Chinese Academy of Science, and national healthcare policies that place an emphasis on early detection. Supportive political environment It's a welcoming political atmosphere, which means there are grants available to you, partnerships and a faster market uptake.

Threat | A Highly Regulated Environment: To the extent it's perceived as a medical diagnostic, our solution is closely regulated – primarily by government entities such as the China National Medical Product Administration (NMPA) and U.S. Food and Drug Administration (FDA). Once the approval process is over you can enter the market, therefor it will keep bad actors from the market in a long time period and avoid saturation.

Legal Factors

Regulatory Approval Requirements and Data Privacy Regulations shape the legal landscape.

Threat | Mandatory NMPA Regulatory Approval

The biggest barrier to market entry is the need for compulsory accreditation from China's National Medical Products Administration (NMPA). The Provisions for Medical Device Registration and Filing require comprehensive review of medical devices to ensure that strong scientific evidence exists for safety and effectiveness prior to the legal market authorization of these products (State Administration for Market Regulation, 2021). Our entire commercial schedule depends on us getting through this process. If they fail or are unduly delayed, that’s an existential risk, burning the cash and forfeiting a crucial first-mover advantage.

Mitigation Plan: Our primary plan is to go after a Class II medical device route as per the classification rules of NMPA. 'We've been able to put in place a process if we present our product as an adjunctive diagnostic, which allows for a vastly quicker and less risky approval pathway." We will work with professional regulatory consultants covering NMPA to assist us in filing the submission and make sure that our trial design meets or exceeds all local requirements.

Threat | Stringent Data Protection & Privacy Regulation

Our diagnostic platform will handle extremely sensitive personal health information (PHI) and hence must comply with the stringent data protection laws in China. Full compliance would include three of the major legislations passed by the central government: namely, the Cybersecurity Law of People’s Republic of China (2017), and Data Security Law of People’s Republic of China (2021), but most importantly, the Personal Information Protection Law for People's Republic of China(PIPL) 2021. Non-compliance can lead to significant penalties, business interruptions as well as the irreparable loss of trust with not only patients and our hospital partners.

Remedial Measures: We have built our data infrastructure around “privacy by design” and we are fully equipped to meet PIPL’s strict protocols for the collection, processing, transfer, etc., of data. Data will be stored locally in Mainland China on secure servers. And we will name a responsible officer to oversee data governance and ensure trust from day one by being open about how robust our data protection is.

Opportunity | Enhancing IP Protection

“Our technology is our intellectual property. Building a robust and protectable patent portfolio in the hyper-competitive market of China - Patent Law of the People’s Republic of China (2021) governed – presents significant strategic upside. Strong filed IP at CNIPA is critical to ensure competitors are unable to copy our innovation and also protect our long-term market leadership.

Strategic Advantage: In recent years, China has remarkably boosted the level of its IP protection laws. We will take advantage of this enabling environment by pursuing a multi-pronged IP protection plan, including patents on core aptamer sequences and unique microfluidic design. This is not only a strong defensive moat but an important asset for securing investment, partnerships, and enterprise value.

Ethical Factors

The fact that you are introducing a tool for early Alzheimer’s diagnosis entails deep ethical obligations.

Responsibility | Patient Autonomy and Informed Consent: We have a moral duty to support our patients. That, he said, means making certain people give fully informed consent before being tested and know just how accurate the test is and what falling into each category of positive or negative would mean to them personally ― particularly since there’s no cure.

Responsibility | Coping with an Alzheimer's diagnosis: An early diagnosis of Alzheimer's can be devastating emotionally and psychologically. We have a moral responsibility to make sure that health care providers are being vigilant in helping patients and their families receive pre and post-test counseling, mental support services.

Responsibility | Promoting Equity of Access: We have to remember to look at the ethics behind access. A major priority will be to establish pricing and distribution models that make our test available equally to all sectors of our population, irrespective of wealth or location, so as not to deepen existing health care inequalities.

Our STEEPLE analysis illustrates a challenging yet dynamic macro-environment for TauTrack. There are significant social tailwinds, including the aging world population, as well as technological opportunities in biomarker science driving a solid market need. But this environment is also haunted by real challenges, such as political and legal constraints that set the ground rules. This is illustrative of the markets huge potential, however it is time we evolve from this bird’s eye view to looking at the competitive pressures within the industry per se. Let’s apply Porter’s 5 Forces model to help us understand the competitive landscape of this industry, and the forces that will directly impact our profitability and strategy.

Figure 6 Porter’s Five Forces Analysis

The Porter's Five Forces give a shining reflection on an intimidatingly competitive industry. The industry’s high barriers to entry are mitigated by the fact that buyers can meaningfully play competitors off each other, and given the threats of competing technologies and ongoing rivalry among established, well-funded rivals. Our industry-level perspective highlights that winning will necessitate a unique and defendable approach. How does TauTrack itself stand in this of all? The below SWOT analysis was used to develop our professional development plans, and is in addition to the competitor analysis with which we analysed where we stand compared to others in the marketplace.

Our TauTrack stands at the forefront of Alzheimer diagnostic with a groundbreaking technology based on state-of-the-art microfluidic chip. Our proprietary technology is based on a custom-synthesised aptamer that enables highly specific and accurate measurement of the BD-tau protein, an important biomarker for early-stage neurodegeneration. To measure our strategy alignment and chance of success, we have compared internally-built strengths and weaknesses with the pressures provided by opportunities and threats in the market place. In the future, for a better expansion in the market, our company can partner with telemedicine firms like Teladoc or Babylon Health for remote AD screening.

Figure 7 SWOT Analysis

Our TauTrack’s detection method has several distinct advantages compared with other existing methods. This is illustrated in the following competitive analysis grid.

Figure 8. Competitive Analysis Grid

To position TauTrack of distinctive features in the current diagnostic landscape, we performed a thorough competitor analysis from six distinct dimensions: Sensitivity, Specificity, Affordability, Risk, Invasiveness and Convenience.

As the visualization illustrates, Tau-Track is the only method that performs well according to all six principles. We develop cutting-edge, high-performance, ultra-usable software at a price that is your starting point.

Here is how TauTrack stacks up against the competition:

TauTrack: Our solution reaches high Sensitivity and Specificity, which guarantee the accurate and safe detection of the BD-tau biomarker. Importantly, it marries this clinical standard with Fetal Medicine solutions that are high on Affordability, low on Risk and non-Invasive (only a simple blood draw), thus highly Convenient for patients and clinicians.

CSF-based Aβ-amyloid protein detection: Additionally a low-risk and convenient blood test, though a recent Version with low Sensitivity has been released which is not suitable for early diagnosis. The inherent lack of sensitivity to detect infection is not compensated for by its reasonable specificity and low cost.

Cerebrospinal Fluid (CSF) Sampling: Described as "gold standard" of precision, it is highly sensitive and specific, but has significant disadvantages. It is very Invasive (spinal tap required), risk-Ridden/ -causing/discomfort, un-Affordable and increadilby inconvenieNt as a method of routine testing.

Neuropsychological screening: Affordable, No risk; Sensitivity and Specifcity highly variable (often fair to moderate for a test). They are helpful in evaluation of the cognitive system, but are not a diagnostic tool per se.

PET & MRI Imaging: PET and MRI scans are Is also helped by both Here, the Sensitivity and Specificity is high. Yet on the other hand, their cost is way too high so they are not affordable enough to be massively used. * They're also REALLY inconvenient, need special apparatus and it takes forever between making an appointment..

CT imaging: This imaging technique is of low utility, with moderate and inconsistent Sensitivity and Specificity. As with other imaging systems, it is still not Affordable nor Convenient for routine diagnosis.

In brief, this analysis validates the TauTrack compelling value proposition that is very unique. It’s set to take a wrecking ball to the market, marrying the accuracy of invasive “gold standard” tests with exactly what our healthcare system — and patients — desperately need: affordability, safety and convenience.

Figure 9 7-P Marketing Matrix

Product

Phase 1: The TauTrack Lab Kit (Market Entry Product): An aptamer-magnetic bead assay of BD-tau protein for use with the ubiquitous standard plate reader available in most diagnostic laboratories. This results in a shorter R&D time-to-market and earlier market adoption through shared infrastructure.

Phase 2: The TauTrack Integrated Platform (Flagship Product): Self-contained, stand-alone, fully automated system composed of our own reading device microfluidic chips. This integrated platform is designed for convenience and low user errors, which is our ultimate goal.

Figure 10. The schematic diagram of TauTrack Microfluidics Diagnostic Platform of BD-tau

Our flagship product, the TauTrack Integrated Microfluidic Platform, is an advanced but very user-friendly diagnostic platform that offers clear and quantitative detection of Alzheimer’s disease biomarker BD-tau using a standard peripheral blood sample. The “sample-in, result-out” approach automates an elaborate biochemical procedure in a self-contained, disposable pocket – and it doesn't require fancy external lab equipment or special technicians. The whole thing is elegantly assembled and turns a mere presence of the protein target into a physical visible signal: the motion of an ink slug that you can easily identify.

The process occurs in three principal steps within the precision-engineered channels of the chip:

Stage 1: Target Identification and Signal Activation (Panel A-i)

When the patient’s blood sample is loaded into the first chamber (which contains our patent-pending cleavage assay) it kicks off. In this case, the BD-tau protein target induces an activation of a Cas12a enzyme complex. This activated enzyme subsequently makes a very specific nick in ssDNA linker molecule. This linker's primary role is to physically link the Platinum Nanoparticle (PtNP) (our signal engine) to a magnetic bead. When cleaved, the PtNP is detached from the magnetic bead. The quantity of released PtNPs is linear with the initial content of BD-tau protein.

Stage 2. On-Chip Magnetic Separation (Panel C-ii)

The chip is subsequently translated, causing the fluid to enter the next region of channel. Then, an external magnet is introduced to trap and retain all the magnetic beads (including bearing or not their PtNPs). This is an important purification step: only the liquid with the actually floating released PtNPs can pass to the next stage, so that the final signal is rather specific and reliable.

Stage 3. Catalytic Amplification and Visual Readout (Panel C-iii)

The purified PtNP-enriched fluid is guided into a reaction chamber, where it is combined with a premixed reagent H ₂ O ₂. The platinum nanoparticles are supercatalysts, quickly decomposing the hydrogen peroxide into gaseous oxygen (O₂). This reaction will give off a large amount of gas, increasing the pressure in the sealed microchannel. This pressure is functionally equivalent to the piston of a syringe, which moves a pre-loaded colored ink slug along an assigned, calibrated reading channel. The greater the distance travelled by the ink slug, the more oxygen produced (which is directly related to the initial concentration of BD-tau protein). A larger amount of BD-tau causes more ink to move, thus offering an easy-to-see and sensitive test without any electric readers.

We also developed a lab prototype for our TauTrack microfluidics diagnostic platform and tested the its functionality accordingly. Please note that due to issues of time and material (especially the difficulty and time-consuming nature of producing integrated platinum nanoprobes, we chose an alternative using aptamer–comDNA–PtNP. By doing so we can design and experiment with all core functions of the TauTrack “sample‑in, result‑out” microfluidics platform comprised “on‑chip no human interference” without changing the chip device process.

How to Reconstitute

A BD‐Tau aptamer is used to bind the PtNP.

The Aptamer contains a short "dock" sequence that will hybridize with a complementary DNA (comDNA).

Streptavidin‐coated magnetic beads are used to capture the biotinylated comDNA.

PtNPs are initially fixed to the beads through the aptamer‐comDNA duplex as a complete sensor.

How It Fits the Workflow on‐chip in Three Stages

Stage 1: Target identification and release

BD‐Tau in the sample will bind the aptamer to destabilize the duplex (assisted by a designed toehold) and displace the comDNA.

Results: The PtNP‐aptamer is released into solution and the comDNA remains on the bead. The level of released PtNPs increases as the BD‐Tau concentration rises.

Stage 2: Magnetic separation

A magnet placed externally immobilizes the beads (together with any PtNPs which are still tethered).

Only the supernatant containing truly released PtNPs can pass through to the next chamber.

Stage 3: Catalytic amplification and readout

The released PtNPs cause decomposition of H₂O₂ to generate oxygen in a closed chamber.

The pressure which is produced pushes a colored ink slug; the distance it moves reflects the level of BD‐Tau.

Figure 11. Prototype of TauTrack Microfluidics Diagnostic Platform of BD-tau

On one hand, this figure shows the encouraging results of a validation experiment carried out on our microfluidic chip proving its fundamental abilities: high specificity and strong, clear, quantitative, dose-dependent response to our selected target biomarker (BD-tau). The purpose of the experiment was to evaluate the performance of the platform with different protein samples, which were read in calibrated reading channels.

On the other hand, even though the current alternative exhibits no reliance on Cas12a reagents or integrated probe synthesis and is fully compatible with the existing microfluidic steps and visual readout, it has following trade-offs:

No enzymatic pre-amplification: Release of PtNPs is capped by binding equilibrium (fraction released ≈ [BD‑tau]/(Kd + [BD‑tau])). At low BD‑tau, signal is weak and close to background; dynamic range is narrower and more sigmoidal.

Sensitivity tied to aptamer Kd: When aptamer has a greater affinity than within range of clinical concentrations, it means that assays will have difficulty obtaining diagnostic LoDs without extended incubations or more PtNP loading.

Risks from "loose neck": Over time, heat fluctuations or pressure changes can bring apart the aptamer- comDNA duplex. Ionic strength variations do so even more easily. As a result, PtNPs are released even without the presence of their target.

Matrix susceptibility: Blood nuclease can nicks ssDNAs; large amounts of surface-active proteins compete or corrupt surfaces; and hemoglobin/catalase both spoil the degradation of H₂O₂. All these raise a baseline and flatten signals.

All of these trade-offs pushed us to revert to our original design as depicted in Figure 10. In this way, we can remarkably overcome the shortcomings of the current alternative.

The catalytic preamplification is intrinsic: Each Cas12a complex cleaves many ssDNA linkers once triggered and also have many PtNPs to represent each target event. This neatly separates LoD from aptamer Kd and makes possible sensitivity orders of magnitude better.

Higher linearity and dynamic range: The cleavage of ssDNA linkers by activated Cas12a scales quasi-linearly with the target concentration, yielding smooth quantitation across several orders of magnitude under both routine and ambient circumstances.

Lower noise and stable base: The cleavage is irreversible gate. Unactivated Cas12a remains quiescent, leaving little spontaneous release compared with a thermodynamic duplex.

Two-factor specificity: Protein recognition (aptamer or affinity capture) and CRISPR collateral collapse (chemical sequence) offer orthogonal selectivity and reduce false positives.

Robustness against sample matrixes: The linker cleavage can withstand blood matrices (buffered Mg2+, inhibitors, time-gated reactions) and the signal is generated post-isolation, less affected by nuclease leakage than an exposed duplex.

Manufacturing consistency: A single defined ssDNA linker between PtNP and bead simplifies synthesis, QC and scale-up, making for more uniform batches of goods.

Expandability and multiplexing: Cas12a, with its guide crRNA, can be reprogrammed. A variety of linkers can be run in parallel passes without revamping the fluid distribution system for panel tests.

Experimental Setup:

Samples of six different loaded parallel microfluidic channels were collected to verify the performance of the assay:

Control: A buffer solution containing no protein to define the baseline (zero-signal) position of ink.

Channel 1# (BSA): Negative control with Bovine Serum Albumin, a typical non target protein.

Channel 2# (Tau): NTC, a general positive control for specificity against non-brain protein.

Channel 3# (1 µM BD-tau): Desired marker with low concentration.

Channel 4# (10 µM BD-tau): Medium in concentration of the target biomarker.

Channel 5# (100 µM of BD-tau): The high concentration reference biomarker.

Analysis of Results:

In fact the results are a very direct and unambiguous proof of concept for our technology:

High specificity verification: The Control channel and negative control channels 1# (BSA) & 2# (Tau) all have little to no displacement of the red ink slug. This is an important finding, as it demonstrates that our assay is very specific. It does not create a false- positive signal in the existence of other high abundant protein even non-target, closely related forms of Tau protein.

Demonstration of quantitative detection: For channels spiked with target BD-tau protein, it exhibits a representative signal (e.g., gradually enhanced) positively depends on its concentration.

On the other hand, in Channel 3#, the 1 µM BD-tau sample produced sufficient oxygen pressure to drive the ink slug a substantial length into the reading channel.

Channel 4 On the contrary, in channel 4\#,10 µM of BD-tau sample (magnified by a factor of ten)can make a much stronger response, driving the ink slug far beyond.

In Channel 5#, the effect of BD-tau was most pronounced when a concentration of 100 µM was used, as the ink slug travelled almost to the top of calibrated channel.

This experiment serves to validate core concepts of our TauTrack integrated microfluidic platform. The see-through, dose-dependent transport of the ink slug demonstrates that it is possible to accurately and quantitatively assess a sample's concentration of BD-tau with our “sample-in, result-out” system. No control channels show any signal, and this lack of off-target is indicative of excellent specificity for our internally developed assay with a high level of confidence. This is a strong proof of concept and shows readiness for additional pre-clinical and clinical advancement of our technology.

Price

Our pricing is designed to capitalize on our two-product strategy, with both stages relying on the “razor and blade” commercial model.

Phase 1 (Lab Kit): Revenue is derived from the consumable assay kits (the "blades") sold on a recurring basis. Because labs repurpose existing plate readers ( the “razor”), there is no massive capital expense for them, easing adoption.

Phase 2 (Integrated Platform): The microfluidic chip is the “razor,” offered at cost or a modest margin. Recurring, high‑margin revenue will come from our proprietary reagent kits (aptamers, nanoparticles, Cas12a), which serve as the essential “blades.”

(For specific pricing, please see our financial part)

Place

Our B2B distribution plans mature with our product offering.

Phase 1 (lab kit): We will focus first on large centralized diagnostic labs and big hospital labs with existing high-throughput plate readers.

Phase 2 (Platform & Place together): The size of the addressable market is much larger. Due to the all-in-one concept, our targeting involves specialistic neurology clinics and smaller regional hospitals, in other words any type of healthcare provider without a complete lab but that will benefit from having testing on site.

Promotion

We will adjust our marketing plan to reach the correct customer in each phase.

Phase 1 (Lab Kit): Message will highlight scientific validation, accuracy and ease of adoption in established lab processes. We will market to lab directors and pathologists via scientific literature, medical shows as well as a technically proficient sales force.

Phase 2 (Unified Platform): The message will grow to emphasize ease of use, speed, and lower likelihood for human mistakes. We will focus our messaging on clinic administrators and neurologists at a high level, with trade show demonstrations, ROI calculators, and case studies emphasizing workflow efficiency.

People

The human capital at TauTrack Diagnostics is purpose-built, integrating three essential pillars to drive our success from foundational research to commercial launch. Our core is the founding iGEM team, a multidisciplinary group of members, PIs, and instructors who provide the foundational passion and deep scientific ingenuity behind our technology. To bridge the critical gap between academic innovation and commercial execution, we are actively recruiting seasoned industry professionals, including R&D specialists, Business Development (BD) staff, and a dedicated Compliance Officer. Overseeing our strategy is a world-class Advisory Board, composed of experts in science, finance, and entrepreneurship. This synergistic, three-pillar structure ensures that our groundbreaking science is guided by industry wisdom and executed with professional discipline, as detailed in our People and Stakeholders section.

Process

Phase 1 (Lab Kit): It’s a standard lab process: A doctor orders a test, samples travel to the central lab and a technician follows detailed instructions in the kit on their own equipment.

Phase 2 (Integrated Platform): Simplification of process to "sample-in, result-out" concept. The platform eliminates the majority of manual labor and virtually eliminates operator error, providing a faster and more consistent result for the physician.

Physical Evidence

The physical evidence of our quality and innovation gets stronger in the second phase.

Phase 1 (Lab Kit): The tangible evidence is the well-branded assay box with secure packing, clear instruction and quality control certificates. We rely on the published scientific literature to establish our own credibility.

Phase 2 (Integrated Platform) The proof of concept is more convincing by means of the minatur has sleek and modern design, a user-friendly interface along with branded sterile packaging as well as other accessories which our readers come packed in as part of complete read and go assay platform. This gives customers a strong physical sense of the high-tech look and reassuring feel of a well-known brand.

We have formulated a comprehensive development plan, the core components of which are summarized in our Business Model Canvas. This canvas provides a clear overview of our key activities and the foundational resources necessary for our venture。

Figure 12 TauTrack Business Model Canvas

Our Business Model Canvas offers an all-encompassing, 360-degree view of the strategic direction of TauTrack and the ways that our key activities and collaborations mesh to serve a lucrative value proposition via well-segmented market. Our model is based on the following:

Value Proposition: providing an early, non-invasive, highly accurate and affordable blood test for Alzheimer’s disease. This goes straight to the heart of the limitations in existing methods, such as painful spinal taps or costly PET scans. We will deliver this value to our most important.

Customer Segments: hospital networks for mass screening, memory clinics to guide intimate diagnostics and directly to the older masses and individuals that are starting to worry about their own health.

Our B2B Customer Relationships will be high-touch, with dedicated account management and strong technical support. We will target these segments with our multi-faceted Channel approach, including medical device distributors, clinical data presented at leading scientific conferences and digital marketing to clinicians.

Our Key Activities to fuel this model, our Key Activities are: ongoing R&D, stringent clinical trials and scalable manufacturing all supported by our patent-protected aptamer-based IP.

This is made possible through Key Partnerships that include venture capital groups, CROs, and world-renowned universities.

Our Cost Structure Weighting shifts toward R&D pre-launch, then transitions to COGS post-launch. Our dual Revenue Streams are structured for growth: ongoing recurring sales of consumable Lab Kits followed by high margin sales from our flagship Integrated Microfluidic Chip coupled with long term service and maintenance contracts.

Figure 13 TauTrack Development Timeline

The TauTrack Development Roadmap highlights our phased, risk-reducing product development strategy that will enable us to push our BD-tau based test products onto the markets in the shortest possible time frame; covering all aspects from company start-up (Dec. 2025) to commercial success of both product pipelines by2032.

The flowchart acts as a visible map of two, but not mutually exclusive paths: although both base R&D on the Lab Kit and the Flagship Integrated Chip are developed in parallel, we will focus efforts on the Lab Kit to reach revenue quicker. Company formation and early R&D will be followed by a phase of (around pre-clinical development from 2027 until ~mid-2028) intense patenting. The 5-years long and resource intensive cycle called: Key clinical testing is planned for 2028-2030.

A crucial step along this path is to file for Class II medical device status with the NMPA in China. It is this strategic choice, to position our product as a companion diagnostic and not a definitive one, that greatly simplifies the approval process. The staged approach builds up to the commercial launch in 2031 of the TauTrack Lab Kit; and, on its heels, in 2032, the more advanced Flagship Integrated Microfluidic Chip – with success of one device supporting sales momentum for another.

Figure 14 TauTrack Financial Timeline

This financial timeline is a graphic representation of our business's progression through the required high-investment, pre-revenue period (the infamous “Valley of Death”) to a sound and profitable footing. The chart below makes it clear that significant planned cash burn is what it takes in the early years to build value for the long term. The early milestone 1 is supported by company establishment and R&D costs, and then substantial investment during the pre-clinical phase (Milestone 2). Our “Peak Burn” (Milestone 3) is our lowest point in cash and is at the most intensive period of capital consumption. The central break-even point is identified at Milestone 4, corresponding to the commercial introduction of our first product, TauTrack Lab Kit, in 2031. That’s the beginning of us climbing out of the valley because we have our first revenue source. The financial trajectory is further supercharged at our Milestone 5, with the launch of our Flagship Chip in 2032, a second product that carries higher margin. The sum of these two revenue streams is a steep J-curve, with an obvious path to substantial profitability and return on investment.

Name,Location and Legal Status of the Enterprise This Business plan is for the development of Tau Track Diagnostics. It delineate cost structure, revenue projected funding requirement and finally financing the product. Our approach is a well-balanced staggered launch of for new products to reduce our risk and speed-to-market. It is indicative of a period of intense, deliberate R&D and clinical validation investment in concert with regulatory approval - after which it becomes an aggressive revenue expansion which aligns with our development and financial schedules.

Use of Proceeds and Funding Needs

Financial plan We will be securing capital on a staged basis to correspond with significant milestones on our timeline. All-In funding amount needed to achieve the break-even point is estimated at 10-15 million RMB, which is raised through 3 main rounds.

Funding Stages & Timeline:

Pre-Seed (Q1 2026)：~5000,000 RMB

The objective: Set up the company, protect IP and reach Proof-of-Concept for both product pipelines.

The current cycle only addresses the R&D phase.

Series A (Q3 2028): ~5000,000-7000,000 RMB

Goals: Fund the pivotal clinical trials, manufacturing scale-­up, and regulatory submission for our first product, the TauTrack Lab Kit. Advanced R&D of the Integrated Platform to be continued.

Series B (Q3 2030): ~3000,000-5000,000 RMB

Use of Proceeds: Fund commercial launch of the Lab Kit, expand sales and marketing team based in China, commence pivotal clinical trials for the TauTrack Integrated Platform.

Table 2. Use of Funds Breakdown (Initial 5 Years):

Category	Description	Projected Allocation
Research & Development	Salaries for 14-member core team, raw materials, lab consumables, equipment procurement (2 phases, total 420,000 RMB), and prototype development.	~45%
Clinical & Regulatory	Costs associated with pivotal clinical trials in China, NMPA Class II/III submission fees, and consultation. This is a major expense pre-launch.	~30%
General & Administrative (G&A)	Laboratory and office rent (annual 125,700 RMB), administrative salaries, legal fees, and operational overhead.	~15%
Sales & Marketing (Launch)	Building a commercial team, initial marketing campaigns, and establishing distribution channels, primarily funded by the Series B round.	~10%

Financial Projections

We therefore anticipate a phased launch for our kit: first the TauTrack Lab Kit (~Q4 2030), and then – circa 2032, once its own regulatory clearance has been secured -- the TauTrack Integrated Platform.

Cost Structure

Fixed Costs (Annual Estimate):

Laboratory Rent: 60,000 RMB

Office Rent: 65,700 RMB

Equipment Maintenance & Depreciation: 10% of the costs to be purchase annually.

Variable Costs:

Cost of Labor: The first team has an annual labor cost of 2,520,000 RMB. This will increase to 6,000,000 RMB by the end of Year 5 in order to fund commercial operations.

Product Costs:

Pipeline 1: TauTrack Lab Kit (Bead-based): COGS: 25 RMB/kit.

Pipeline 2: TauTrack integrated platform (Single-use chip) COGS, 305RMB/chip.

Revenue Model and Forecast

Our business model is driven by direct sales of our two diagnostic products.

Pricing Strategy:

TauTrack Lab Kit: 368 RMB。

TauTrack (Single Use Chip) The TauTrack This single-use chip costs 20% less than OraSure's product and retails at 1,168 RMB.

Sales Volume Forecast:

The lab kit will come out first and establish a base of revenue for one year prior to the platform's roll-out.

We for esee a 40-60% compound annual growth rate (after launch) on both products but that it will plateau after a period of time.

The "Valley of Death" and Profit Forecast

Our financial timeline is very realistic as it features a substantial "Valley of Death" in the Pre-revenue Period (2026-2030). The higher margin Platform product is delayed and therefore the first commercial years are supported only by the Lab Kit, pushing profitability out further but providing for a more conservative yet credible outlook.

Projected Profit & Loss (Illustrative 5-Year Commercial Forecast): (Note: "Year 1" below refers to the first full year of commercial sales

Table 3. Financial Forecast after Products Launch

Metric	Year 1 (2031)	Year 2 (2032)	Year 3 (2033)	Year 4 (2034)	Year 5 (2035)
Lab Kit Sales	40,000 units	70,000 units	120,000 units	200,000 units	300,000 units
Platform Sales	0 units	3,500 units	6,000 units	10,000 units	15,000 units
Total Revenue	14,720,000 RMB	30,050,000 RMB	51,036,000 RMB	85,320,000 RMB	127,950,000 RMB
COGS	1,000,000	2,817,500	4,830,000	8,050,000	12,075,000
Gross Profit	13,720,000	27,232,500	46,206,000	77,270,000	115,875,000
Operating Expenses	~7,000,000	~8,500,000	~11,000,000	~15,000,000	~20,000,000
Net Profit/(Loss)	6,720,000	18,732,500	35,206,000	62,270,000	95,875,000

For our sales projections, we have based these on a large and growing requirement for early detection of Alzheimer’s disease in China.

Market Size & Opportunity:

Demographics Aging population In 2023, China's elderly population reached almost 297 million people (Shine, 2024), which is expected to exceed 400 million by the year 2040 (WHO, n.d.). This forms a very large at-risk population for age-related cognitive decline.

High Pervalevce of MCI: The rate of Mild Cognitive Impairment (MCI), the important early stage to our detection products, in China's senior population is between 14.7% and 19.6%.(Xue et.al., 2018) This represents a market potential of over 40 million people today.

Health and Medical Care Infrastructure: China runs a massive number of hospitals. By 2022, there were almost 2,800 tertiary public hospitals (level 3) and thousands more level-2 hospitals (HEALTHCAREASiA, 2024).

Go-to-Market Strategy & Penetration:

Our approach is to gradually infiltrate the Tier 2 and 3 hospitals that are equipped to handle the required patient volume.

Year 1 Target: We’ll start by targeting 100 Tier 2/3 hospitals.

Adoption Rate Assumption: We estimate that a typical target Hospital will use about 400 tests per year using our Lab Kit. This is roughly 30-35 tests a month, an adequate number which can be used in screening high risk patients ( for e.g. history of family members / having certain symptoms/ premium health check-up protocols).

Our bottom-up analysis, therefore, has resulted in a redefinition that is markedly more ambitious but yet realistic and feasible.

Lab Kit (Screening Tool):

Year 1 (2031): 100 hospitals *400 tests/hospital = 40,000 units

Growth: We estimate a strong hospital adoption growth and further penetration in the existing account.

Integrated Platform (Premium Diagnostic):

Launches in Year 2 (2032).

We estimate 1 Platform for every 20 Lab Kits sold‎, as it is for patients screening positive or having a more clinical need.

Why It Is a Beneficial Investment:

• Strong market demand for low-cost, non-invasive detection exists, with unmet needs on both the clinical and patient sides.
• Economies of scale, achieved through low per-test prices and large-scale usage, will expand profit margins.
• If covered by insurance and medical insurance, the product’s popularity will increase further, enhancing return certainty.

TauTrack Diagnostics success is powered by its human capital such as a powerful combination of underlying enthusiasm, global leading edge advising and experienced execution knowledge. What constructed has been our Human Resource Policy based on 3 basic pillars to go through the path an innovative idea -to- a leader company born.

The Founding Team: iGEM Innovators

At the heart of TauTrack is our team of 15 enthusiastic iGEM members. The interdisciplinary team behind our core tech This is the innovation and creativity in engineering spirit. As the founders of the project, they have profound comprehension for the aptamer-based Cas12a assay and great perseverance, bringing tremendous energy and passion to support the future development of this company.

Strategic Guidance: The Advisory Board

In order to add substantial industry and commercial knowledge to our core team, we are building a world-class Scientific and Strategic Advisory Board. We have considered inviting some of our interviewed experts to serve as our board members and would build our board beginning with this group, for instance:

Prof. Chunyi Hu: CRISPR expert from National University of Singapore (NUS) who will play an instrumental role in validating and optimizing our fundamental scientific approach.

Dr Mark Kotter: Dr Mark Kotter (University of Cambridge) is a pioneering entrepreneur, the Founder of bit. bio, which joins academic research with a sustainable commercialization, and advises us on the go-to-market strategy.

Mr. Zhang: A FRM holder and senior financial consultant who is of paramount importance to our overall financial direction as well as fund-raising and stable expansion strategy.

We will communicate with these experts to confirm their interest after iGEM.

Execution & Scaling: Building an Experienced R&D Team

Never losing sight of the reality that innovation without execution is just random thought, a first key priority in the near-term is to hire a seasoned R&D team. To convert our technology into a regulated, manufactured and commercially successful product in China, we will hire experienced staff with experience of IVD (InVitro Diagnostics) product development, NMPA regulatory aspects manufacturing scale-up. This small team will chart the critical path from prototype through to pivotal clincial studies and market launch, delivering on our ambitious development timeline.

Figure 15 Stakeholder Analysis

At TauTrack Diagnostics, the foundation of our work is a human-centered design philosophy. We consider that a medical innovation will never be successful in silo. So stakeholder engagement is not an afterthought but inspirations for our product design, regulatory strategy and commercialization plan. Such a systematic process of listening to what’s needed, learning deep, and then integrating the real world needs is how we insure that we are not just building cool technology for technology sake but creating effective solutions with meaningful impact for an entire ecosystem.

We manage this process using a stakeholder analysis matrix, in which we prioritize our interactions depending on how influential that group can be to propel us forward while showing its support and interest for our mission. That’s enabled us to prime two important networks: a small number of high-input strategic partners who will help build the company, and a broader group of high-buy-in advocates who give our mission its life.

Key strategic partners (Manage closely)

We find in this quadrant all the whales who could decide to make a difference and directly shape our success. In the journey from lab to market, they are our co-pilots. This group has been central to our core business strategy.

Speaking of Investors & Commercial Leaders (including Dr Mark Kotter, bit. bio): Our conversations with experienced biotech CEO’s proved out the commercial viability of our dual-product strategy. The tactical insight to first introduce the low-cost Lab Kit as a testing of the waters "foot in the door" before we expend R&D resources on building out our microfluidic chip lays down the cornerstone of this staged go-to-market plan.

Clinicians (i.e., Dr Qingli Li, Chief Psychiatrist): Observations from the "why" of our project from clinical frontlines. exposed the severe limitations of the current diagnoses (invasive, costly and subjective) corroborated that a simple, non-invasive and objective biomarker test is urgently needed in the clinical practice.

Business & Regulatory Strategists (e.g., Mr. Zhang), Financial Consultant – “The Roadmap” This deliverable offered project partners a realistic set of procedures for gaining entry into the China market. Mr. Zhang’s tenacious recommendation to pursue a reasonable risk Class II (auxiliary diagnostic) regulatory pathway vs. high-risk Class III (definitive diagnostic) is an enormous strategic decision that de-risks our timeline, capital requirements and provides a much more rapid road to initial revenue.

Manufacturers (e.g., Beijing Genome Biotechnology Co., Ltd.): Our visit to the POCT manufacturer was fantastic and eye opening. It crystallised our approach to product design around the "sample in, result out" paradigm, and gave us a way to make sure that the automated microfluidic chip is necessary.

Key Enablers (Keep Satisfied)

This group is high power but possibly lower in direct interest in our daily work. It is our utmost want that all of their needs are taken care of to minimize the potential obstacles.

Regulators (e.g., NMPA in China): We have not interacted with these bodies directly, however Mr. Zhang and Dr. Li have been advising on how to prepare for their requirements throughout our entire regulatory approach 4. We have structured our introductory product as a Class II screener for an established protein (Tau) so that we are following the more focused and lower-risk approval process.

Future Insurers & Healthcare Payers: Our GTM approach includes collaboration with insurers to incorporate our test into preventive care bundles. We are targeting a simple and low-cost screening method to be consistent with their financial as well as labor-saving health goal.

Community and Moral Compass (Stay Tuned)

This is the biggest and, some would argue the most important, quadrant, the ones we’re working for and whose broader community our project owes its social license to operate. They may have little direct power, but their high interest means they are among our most important champions.

Patients & Families e.g., Mr. Wang's family) The personal, relatable story of Juergen and his family's 6-year journey with Alzheimer’s revolutionized our mission: To Change What it Means to Live with Dementia! It changed our perspective from building just another diagnostic “tool” to a full-fledged “support system.” What he’s asking for, “an earlier, clearer answer,” is the human mandate we operate under (and easy to read that into our statement’s wordings), one that cuts to the quick of what drives us and why we felt compelled to build an empathetic, accessible line of work.

Society: Our public survey further validated the clinical need on a society level. The results indicated an awareness of AD but a lack of knowledge. Importantly, 96.4% of them agreed the benefit of a non-invasive test and more than half (54.5%) are confident towards hospital (z )ee practices, verifying our launch personas targeted by early-stage partnership-driven go-to-market strategy.

Technical & Academic Partners: Regular input by the experts in CRISPR (Dr. Hu), neurobiology (Dr. Lu) and microfluidics (Dr. Han) has been crucial to stress-test our science, making sure our technology development is sound, solid, and moving toward a feasible product.

In short, this deep level of integration across a broad set of stakeholders helped inform what wasn’t the business plan at all: one based on assumptions but rather based deeply in validated clinical needs, realistic commercial approaches and deep human insights. This significantly derisks fantastic and positions TauTrack to offer a solution that the market is poised for, in fact waiting desperately for a solution like this.

Risk Description: Big Bang Pharma The Alzheimer diagnostic sector is dominated by the Armies of the true pharma giants. Key competitors such as Roche and Eli Lilly are pursuing active development and bundling of their own diagnostic tests (e.g., p-tau217 assays) with therapeutic plays. This makes for a high barrier to entry, especially since capturing market share from these vertically integrated trusted sources can be difficult for a new company.

Potential Implications: In the absence of such a strong and obvious value proposition, TauTrack may struggle to stand out in practice. Best-of-breed offerings from mature companies of the Noah Sort may seem an "obvious" choice which hospitals, docs, and payers decide to avail themselves of since they are tried, true and integrated into extant work flows. This may make a fight for meaningful marketshare (even with the superior science).

Mitigation Strategy:

Affordability & Accessibility: We will establish the TauTrack Lab Kit as the most affordable, user-friendly and accessible screening option in a market where overexpensive PET scans or complicated lab-based tests left us an open space with many windows of opportunities.

Staggered Go to Market: We will be addressing neglected regions, with less presence of established players in such objective segments. This would include memory pathology clinics, secondary hospitals (Class 2), and rural or markets where there is a dearth of advanced diagnostic facilities.

Strategic Partnerships: We plan to work with local health care systems, public health efforts and payers to carry out a health economic study showing the substantial long-term cost savings derived from early detection facilitated by our affordable technology.

Risk and Impact Specification: Pre-Revenue biotech The company is a pre-revenue biotech turning the corner to finally getting into the clinic. Risk/Vulnerability Description: As for all biotechnology companies, TauTrack does face a long period of significant negative cash-flows (valley of death). The timing of receiving regulatory approvals and generating initial revenues is inherently uncertain and can be delayed. On the other hand, R&D, trials and staffing are expensive fixed costs that also can't be negotiated. A surprise moratorium would leave a huge and dangerous hole in liquidity.

Potential Impact: A lack of cash runway could require the company to slow down or stop crucial operations such as pivotal clinical trials and submitting applications to regulators. Not only would this push the product launch later, but it also could squelch the confidence of investors. In the worst cases, the company might run out of money before it gets anywhere near being able to do that, and it will die even though he has strong science.

Mitigation Strategy:

Conservative financial models: We constructed our financial models based on conservative assumptions, including cushion for delays in revenue and longer than expected approval timelines.

Build a War Chest: Part of every round will go into a separate reserve fund to deal with unforeseen operational expenses or cover slow cash flow times.

Proactive Fundraising Strategy: We will commence an early investigation of follow-on funding alternatives for maintaining a healthy runway.

Disciplined Management of Budget Priorities: We will take steps to manage our costs prudently and perform a full budget review process, to further refine our cash burn rate and cut any unnecessary expenses.

Risk Description: Obtaining approval from regulatory authorities such as the NMPA in China is a required, complicated and high-stakes obstacle. The approval procedures are one of both time-consuming and expensive nature, requiring strict compliance with very stringent standards. Even small discrepancies in the clinical development and compliance studies can lead to significant slowdowns or even denial.

Why it Matters: A failure to achieve prompt approval would be devastating. It'd make our product non-sellable…Meaning, years of R&D and a ton of capital just flushed down the pan. In addition, every minute lost surrenders important market share to rivals and risks doing enduring harm to the company’s standing with regulators and investors.

Mitigation Strategy:

Engage Expert Regulatory Council: We will retain counsel with the ability to navigate the NMPA's Class II and III IVD approval process in China.

Design for Compliance: Our product design, QMS and clinical trial protocols are being created with NMPA standards in mind to reduce the likelihood of costly re-work down the line.

Factor in Cushions: For The Worst Case Scenarios: Our timeline and budget have been planned to accommodate buffer for the regulatory period to cover any of what could go wrong without threatening with complete failure of our business plan.