Our mission:
Our mission is to create a start-up that provides research and development (R&D) into a cheaper more accessible diagnostic test for infectious diseases. To begin with, we are focusing on a diagnostic test for latent TB and then in the future once our brand and company has been established we will think about expanding to cover different diseases.
Tuberculosis (TB) has been the leading most deadliest disease since the 18th century [1], and still is to this day. As recently as 2023, TB was responsible for 1.25 million deaths worldwide [2]. The disease is a bacterial infection caused by Mycobacterium tuberculosis and primarily affects the lungs, but can spread to other parts of the body. The bacteria is transmitted through the air via droplets from coughing and sneezing.
In recent years, there have been many advances in developing new vaccines, drug treatments and diagnostics for TB. All this work is being done so that the World Health Organisation's (WHOs) goal of eradicating TB by 2030 [2] can be achieved, and we believe that our new diagnostic test will make a meaningful difference to this goal.
TB comes in two forms: active and latent TB. Our test focuses on detecting latent TB, the non-infectious, asymptomatic form of TB. The idea is that this will reduce the spread of the TB bacteria, as infected patients can seek out treatment before it becomes active, transmittable and deadly.
In addition, current diagnostics for latent TB are non-specific, require extensive lab equipment and specialists. This makes testing individuals in rural and low-income regions harder as there is not the available resources. Our test helps to relieve these problems by being portable, easy-to-use and specific to latent TB biomarkers.
Market problem and users:
The market problem within this field is that current tests do not provide accessibility to certain communities, especially those in low-income, high-burden areas. Countries that experience some of the highest incidence of TB include: India, Indonesia, Philippines, Bangladesh and Pakistan. One factor that affects the accessibility of healthcare for individuals of communities in these countries is the direct out-of-pocket costs that include not only the medical fees but also associated expenses like transport, lost wages, and childcare. This makes healthcare financially inaccessible to some individuals. With our plans to organise a distribution system that allows the test to go to those that need it most, we believe we can reduce some of the out-of-pocket costs associated with getting diagnosed.
Our case study for human practices focuses on The Dominican Republic. It is classified as one of WHOs 12 priority countries in the Region of the Americas [4]. When initially launching our product, we will target the individuals who live in the crowded slums of the Dominican Republic that struggle to access TB diagnostics due to societal and economic disadvantages. More information on our case study can be found here.
In addition to current tests being poorly accessible, they are unable to distinguish between latent TB and active TB making it difficult to diagnose and provide the correct treatment. The two current forms of TB diagnostic testing are the Tuberculin Skin Test (TST) and the Interferon Gamma Release Assay (IGRA).
TST is conducted by injecting a small amount of tuberculin purified protein derivative (PPD) into the skin of the forearm, results can be read after 48-72 hours by measuring the diameter of any skin thickening (induration). The test requires multiple hospital visits and lots of patients do not follow up because of this. It cross-reacts with the bacille Calmette-Guérin (BCG) vaccine, leading to false positives, the prevalence of false positive results is 41.8% [4]. TST can also cross-react with non-tuberculous mycobacteria and false positive results range from 0.1% to 2.3% [5].
IGRA, while it is more accurate, is costly, requires laboratory facilities, and is invasive as a 3-4 ml blood sample is needed [6]. We aim to reduce the need for venipuncture and make the test more accessible to communities who don't have the resources and personnel.
Our solution:
Our diagnostic test integrates microfluidics with a lateral flow assay to combine precision sample preparation with simple, field-ready readouts. This dual-stage design allows the assay to maintain laboratory-grade accuracy while remaining portable, low-cost, and easy to interpret. The combination of microfluidic control with the established scalability of lateral flow tests (LFTs) provides a practical route to mass deployment in both centralised and decentralised healthcare settings.
Our final product detects multiple miRNAs upregulated in latent TB, using a 35 microlitre blood sample. The test has a predicted sensitivity of 0.123pM, 3 month shelf-life, and delivers results in 15 minutes through a multiplex system [7]. By following the REASSURED guidelines for point-of-care diagnostics, this test offers greater accessibility compared to existing detection methods. [8]
We first chose reproducible and specific biomarkers, which were exosomal miRNAs seen to be upregulated in latent TB: hsa-miR-363-5p, hsa-miR-7850-5p, hsa-miR-6529-5p and hsa-miR-1306-5p. We chose exosomal miRNAs as their thermal preservation is ideal for sample storage and we aim to test them in a multiplex system so they are specific to LTB. The collection of the blood sample can be done with a fingerprick which is easy and user-friendly.
Next, we used microfluidics to isolate plasma from the blood sample, isolate exosomes and extract the miRNAs. We chose this method as it's a portable device and a lab-on-a-chip which can be implemented into low-resource settings whilst also working with small blood samples.
After the miRNAs are extracted, they are isothermally amplified using a technique called cyclic chain displacement reaction (CCDR). The miRNA binds to a primary DNA1 hairpin loop to open it up. Then a secondary DNA2 hairpin loop can bind to DNA1, whilst displacing the miRNA so it can be recycled and the process repeats. For our test, DNA1 hairpin is modified with biotin and DNA 2 has FAM at the 5' end. This detection method amplifies low concentrations of miRNA to make the test sensitive and uses DNA probes which are more affordable than proteins and stabler than RNA.
This method can be implemented into a LFT. The conjugate pad contains antibodies conjugated to gold nanoparticles. Gold nanoparticles produce a visible signal which is easy to interpret with no equipment. The test line detects the hybridised reporter probe, and hence only shows a signal if the miRNA are present whereas the control line always has a visible signal if the test works. The test can be adapted into a multiplex system by including two more DNA probes which are specific to an alternative miRNA. We chose a lateral flow test because it's a native paper-based test format that can be implemented outside of a lab and gives quick results thus making the test user-friendly, robust and affordable. [7]
Technology- how our product works:
Market analysis:
Competition:
By analysing the competition, we can determine our position in the competitive landscape of the infectious disease market and identify opportunities for differentiation. We have mapped direct, indirect, and emerging competitors to identify where current solutions fall short and demonstrate why your approach is needed. This analysis helps clarify our business model and potentially form strategic partnerships.
Direct competitors:
These are companies that have already established tests on the market that diagnose latent TB.
| Competitor | Key Features | Financing Status | HQ Location | Primary Industry | Year Founded |
|---|---|---|---|---|---|
| QIAGEN [15] | They offer TB testing (IGRA assays) | Public company, established revenue streams, large scale operations | Netherlands | Molecular diagnostic/ in vitro diagnostics (IVD) | 1984 |
| DiaSorin [16] | Offer tests like LIAISON QuantiFERON TB-Gold plus | Public company; wide diagnostics portfolio; solid infrastructure. | Italy | Molecular diagnostics/IVD | 2000 |
| Cepheid [17] | Molecular TB diagnostics (Xpert MTB/RIF) automates PCR for TB and resistance detection | Strong backing and scale; finances are integrated with Danaher | California, USA | Molecular Diagnostics, IVD | 1996 |
| Hain Lifescience [18] | TB molecular genetic assays, line probe assays, detection of TB and resistance | Private company, not publicly traded, acquired by Bruker Corporation | Germany | Molecular diagnostics, microbiology | 1986 |
Indirect competitors:
These are vaccines, preventive therapies, AI/digital screening tools, multiplex diagnostics, and public health strategies that reduce the demand for latent TB testing.
| Competitor | Key Features | Financing Status | HQ Location | Primary Industry | Year Founded |
|---|---|---|---|---|---|
| bioMerieux [19] | Offer IGRA-type tests and products for TB diagnostics | Large public diagnostics company; well-funded, global presence. | France | Clinical Diagnostics/IVD | 1963 |
| Roche Diagnostics [20] | Strong molecular diagnostics capabilities and broad infectious disease goals, including TB. | Public, very large; high R&D budget; capable of integrating new methods. | Switzerland | Molecular diagnostics/medical devices | 1896 |
Future competitors:
These are companies/ research that is being developed that could be a better alternative to our test.
| Competitor | Description | Status | Location |
|---|---|---|---|
| Lucira Health [21] | Production of inexpensive, disposable health diagnostic hardware | Public | Emeryville, California, USA |
| Cofactor Genomics [21] | Precision medicine with predictive diagnostics; biomarker identification | Active | Montana, USA |
| BillionToOne [21] | Genetic platform for non-invasive prenatal test | Active | California, USA |
| Starling [21] | Analysis of urine for hospitalisation prevention | Active | Texas, USA |
Development plans:
Key activities:
Acquire funding:
Development of our business requires significant resources and funding in order to succeed. We plan to implement several marketing strategies and reach out to potential sponsors and organisations.
Completing proof of concept:
Before we can sell and distribute any product, we must first have a solid proof of concept. More information about our proof of concept is available. Once our proof of concept is established, we can confidently say that we have a functioning test that stands up to the competition.
Register our company and trademark our brand name:
Once our proof of concept is well-supported by evidence, we can register as a UK-based Limited Company through Companies House for £50. Afterwards, we can trademark our branding in the UK for £170. Note that this trademark will only cover the UK, so we will also need to consider international intellectual property protection.
Clinical trials:
Once we have a prototype of our product we need to carry out clinical trials to demonstrate that the test can diagnose effectively.
Regulatory approvals:
Since we are planning on distributing our test globally we need to receive regulatory approvals from WHO Prequalification of diagnostics. More on the cost of this process can be found in the financials section.
Establish distribution and manufacturing channels:
Once we have a viable product, we will begin reaching out to companies to licence our product to. One business partner will provide us with a manufacturing process which can be scaled up inline with current factors. Additionally, we will establish a partnership with a distribution company that will be able to outsource our test to sites in selected high-risk communities. You can find more information about this on our implementation page.
Key resources:
A fundamental requirement for our start-up is access to lab space and resources to support research and development of our test. We will depend on a steady supply chain of reagents and laboratory equipment essential for our investigations and product development. Drawing on expert knowledge of latent TB biomarkers, we aim to make our test more specific for latent TB. Currently some biomarkers associated with latent TB are also upregulated in other diseases, leading to false positives, and we aim to minimise these occurrences. Additionally, as a start-up, we must invest in marketing and business development expertise to secure adequate funding and ensure the successful advancement of our product ideas. As part of our marketing efforts, we plan to reach out to organisations and biotech companies for funding opportunities. For international brand registration and trademarking, we will require intellectual property expertise to guide our decision making.
Key partners/ stakeholders:
We have already reached out to companies and researchers for assistance with funding, resources, and expert knowledge of the field. Additionally, we have consulted with doctors and patients regarding product development, which has significantly influenced our product's design and functionality. More information can be found here.
Value proposition:
We aim to develop a diagnostic test that is more affordable than those currently available, giving it a competitive advantage and improving patient accessibility. Our test's minimal reliance on laboratory infrastructure and expensive equipment makes it field-deployable, particularly suited for low-resource regions. Unlike existing TB diagnostics, our test is designed to specifically detect latent TB biomarkers, allowing clear differentiation between active and latent TB cases, thus streamlining the diagnostic process. Additionally, because our test uses a finger-prick blood sample, it eliminates the need for venipuncture, trained specialists, or a hospital setting, further enhancing accessibility and ease of use. In the future, our platform could be adapted to detect other infectious diseases, supporting the company's growth and expansion into new markets.
Customer relations:
We must develop long-term relationships with researchers and biotech companies to support the growth and market establishment of our research. It is also important to build strong connections with manufacturing and distribution partners, ensuring our product can reach patients. Our company's interaction with patients will occur exclusively through our distribution agreements.
Channels:
By partnering with established TB diagnostic and biotech companies, we can build credibility and valuable networks to support our brand's growth. Through targeted marketing initiatives, we will inform the general public about this alternative diagnostic test, aiding its distribution in high-burden areas.
Customer segments:
To establish our product in the market, we will need investment from biotech companies for research and development. Alternatively, partnerships with NGOs could help increase community access and awareness, as well as support efforts to include our test in national TB programs. This approach will bridge the gap between our innovation and the communities that need it most.
Long term, our customers will be patients at risk of TB exposure worldwide, who can access our test at the nearest distribution site. With NGO partnerships, healthcare providers globally could use our test once we demonstrate its competitive advantage over existing options.
Cost structure:
There are many competents of our company's development that require extensive funding. The main costs are from research and development, as it will take many iterations to develop the final product. Once we have a prototype and have completed clinical trials, we will need to budget for regulatory approval. Other one time costs include registration and patent costs to ensure we have licensing opportunities and protection when selling to partner companies. Marketing costs are estimated to be around 8-12% of our revenue [22].
Revenue streams:
Our primary revenue will come from grants and subsidies provided by global health funders and investors. Partnerships with NGOs and pharmaceutical companies will also allow us to sell test kits as packages with other pharmaceutical products, or directly in hospitals and clinics. Once we license our product to a manufacturing company, we will earn royalties for each test produced. In the future, developing diagnostic products for other diseases could further expand our revenue streams by opening new market sectors.
Market strategy:
7Ps
Product:
Our product is a diagnostic test specifically designed to detect biomarkers that are upregulated in patients with latent TB. This enables the test to differentiate between active and latent TB cases. A key advantage of our product is its lower cost, increased accessibility, and portability, making it ideal for field use. These factors provide our diagnostic test with a competitive edge and align with our startup's primary goal in idea generation.
Price:
The price of our latent TB diagnostic test is set to balance both affordability and sustainability. Our goal is to offer a test that is significantly less expensive than current diagnostics such as IGRA and TST, which are often costly or logistically challenging, especially in low-resource settings. By utilising a paper-based lateral flow format and cost-effective materials such as polylactic acid (PLA) for cassettes, we keep production costs low, allowing us to price the test within reach of low-middle-income countries. Pricing will also cover manufacturing, distribution, and ongoing R&D to ensure the test's long-term viability. We plan to implement a tiered pricing model, enabling international donors, NGOs, and high-income countries to pay slightly higher rates to help subsidise access in low-income regions. This strategy supports access for vulnerable populations and creates a sustainable financial model for scaling impact.
Promotion:
Our primary promotional targets are existing TB diagnostic companies, biotech firms, and healthcare providers. Collaborating with established companies will expand our network and enhance our brand credibility. Additionally, we will showcase our research and development efforts at major biotech conferences to attract funding and forge further collaborations crucial for our growth.
Place:
In the long term, we plan for our test to be found in pop-up field sites in local communities that are affected most by TB.
Packaging and physical appearance:
The test cassette will be made from microalgae-based PLA, which is a more sustainable alternative to traditional LFT cassettes. Our test features two separate areas for sample loading and readout, allowing for the simultaneous detection of two miRNAs.
Similar to standard diagnostic test packaging, our diagnostic test will first be enclosed in a leakproof primary receptacle, followed by leakproof secondary packaging containing absorbent material, and finally a rigid outer cardboard box.
Our test kit will include a test strip, a lancet for patients to collect a blood sample by pricking their finger, and a leaflet containing essential information, instructions for performing the test, and guidance on next steps in care.
Process:
We will develop and fine-tune our test to ensure the kit we provide is both more accurate and accessible.
Once our test has been established, we plan to outsource distribution of our kit to a company that will deliver it to sites chosen in line with TB prevalence. Trained personnel will be hired to assist and guide individuals through the testing process and interpretation of results. As a start-up, our primary focus is on research and development of the test itself, ensuring it can be deployed to areas most in need.
People:
Engaging directly with doctors and patients from the Dominican Republic, alongside expert researchers in TB and diagnostics, has been crucial in shaping the development of our final product. From clinicians, we gained practical insights into the limitations of existing diagnostics, including the difficulty of interpreting results and the lack of accessibility in under-resourced areas. Patients shared their perspectives on stigma, affordability, and barriers to care, highlighting the need for a test that is not only accurate but also easy to use and socially acceptable. Expert researchers helped us refine the scientific approach, ensuring that our test design aligns with global best practices and regulatory expectations. These diverse perspectives allowed us to design a diagnostic tool that is scientifically robust, affordable, and context-sensitive, directly addressing the real-world challenges faced by communities most affected by TB.
Total Addressable Market (TAM), Serviceable Available Market (SAM), and Serviceable Obtainable Market (SOM)
TAM: The estimated global latent TB burden is 2 billion people.
SAM: Targeting 20% of at-risk populations results in 200 million tests.
SOM: In the first 5 years, 1% of the SAM equates to 2 million tests.
Market entry and exit strategy:
Market entry:
Our market entry strategy targets high-burden, low-middle-income countries where the need for latent TB diagnostics is greatest and current solutions are limited. By partnering with NGOs and global health organisations, such as the WHO, we aim to position our test as a cost-effective and accessible alternative to TST and IGRA. Initial entry will be backed by pilot programs and demonstration studies in regions of the Dominican Republic to generate real-world evidence of the test's effectiveness, affordability, and ease of use. Building on this foundation, we plan regional expansion through licensing agreements with established manufacturers and distributors to support scalable production and distribution. At the global scale-up stage, we will seek broader regulatory approvals, integration into national TB control programs and procurement through international health initiatives like the Global Fund. This rollout model ensures evidence-driven, sustainable, and adaptable adoption to different healthcare infrastructures. By combining clinical validation, strong stakeholder partnerships, and a focus on affordability, our strategy secures both commercial viability and maximum health impact.
Market exit:
For our latent TB diagnostic test, a likely exit plan involves a merger or acquisition (M&A) with larger diagnostic or global health companies. Established companies already have global regulatory approvals, advanced manufacturing capabilities, and robust distribution networks, which can greatly accelerate the test's availability in both high- and low-income countries. Alternatively, licensing the technology to global diagnostic firms or nonprofit organisations would ensure the test remains available without drawing the high overhead costs of full-scale operations.
An acquisition would provide our innovation with financial stability, access to experienced commercial teams and integration into broader diagnostic portfolios, enhancing adoption and impact. A merger could allow us to retain more influence over the technology's direction while combining resources, expertise, and market access.
By partnering with established diagnostics leaders, ensures our product progresses beyond pilot programs to widespread use, offers investors a clear return and secures the innovation's long-term sustainability.
Intellectual property:
Overview:
As part of our Entrepreneurship work, we recognised that intellectual property is critical for turning an idea into a viable product. Filing a patent not only protects innovation, but also provides credibility when seeking investors, partnerships, or licensing agreements. However, IP was an area none of us had prior experience in. To learn more, we reached out to Dr. Sara Holland, a Nottingham-based patent attorney, who kindly offered us her time and expertise.
Before our meeting, Dr. Holland recommended that we read two introductory resources: Timeframe for IP and IP for Scientists. These guides gave us valuable background knowledge, particularly around timelines, costs, and common misconceptions about patents.
Key lessons from our consultation:
Our discussion with Dr. Holland was structured around the key components of our test: sample, biomarker, detection method, and readout. Some of the most important things we learned are summarised below:
Author, Inventor, Freedom to Operate
Just because you are an author on a publication or inventor of a technique, it does not automatically give you the right to use it commercially. Freedom to operate requires checking existing patents and publications.
What qualifies as a patent?
To be patentable, an invention must be novel and inventive. We initially thought novelty meant "different from existing TB tests." However, we learned novelty is assessed against every prior publication - not just existing products.
What makes our approach unique?
Our biomarker panel alone cannot be patented, since it comes directly from a published study. However, combining the panel with CCDR (Cyclic Chain Displacement Reaction) for detection might be inventive, especially if this has not been reported before. If CCDR itself has been used in this way already, novelty could come from integrating it into a microfluidic chip or from the way we adapt CCDR to a lateral flow readout.
The value of "failed" studies
If a paper states "this method did not work" and we make it work, that is highly inventive. If a paper states "this method has potential," then replicating it makes the solution more obvious, and therefore less likely to be considered inventive.
Broad versus specific claims
Dr. Holland advised that patent applications should be written as broadly as possible (e.g., "detection of biomarkers using isothermal amplification on a paper strip"), and then narrowed down only when necessary. This maximises protection and allows flexibility for future product development.
Application to our project:
Through this consultation, we reframed how we think about our test:
Novelty: not simply that we are developing a new TB test, but that we may combine existing elements (biomarker panel + CCDR + paper strip) in a way that has not been done before.
Inventiveness: the integration of CCDR into a lateral flow format could represent a significant step beyond current methods.
Business plan integration:
IP protection fits directly into our prototype-to-licensing model. Our role is to develop a working prototype, secure patents around the inventive aspects, and then license the technology to manufacturers who can scale production. Importantly, we also learned that IP can be filed on the concept - we do not need a fully functional product before applying.
This experience highlighted the complexity of intellectual property and the importance of engaging with experts early. It also reminded us of one challenge unique to iGEM teams: our projects are disclosed publicly on the wiki, which may affect novelty. Any real-world commercialisation would require careful coordination between publication and patent filing.
Overall, our consultation with Dr. Holland was invaluable in teaching us how to think strategically about novelty, inventiveness, and patent scope!
Financials:
Research and development:
The estimated cost for development and engineering of medical devices is at least $2.5 million USD. [23] This will include the costs for reagents, equipment and personnel.
Clinical validation:
The estimated cost of clinical trials is $24 million USD [23]; however, this amount can vary depending on sample size, study power, and duration.
Regulatory approval:
In order to receive regulatory approval for global health programs, we need to submit a full prequalification assessment which has a fee of $5,000 USD for dossier screening and $12,000 USD for product assessment. This is followed by an annual fee of $4,000 USD to maintain the approval. If we want to make any changes to our product in the future we need to submit a Change Request Form with a fee of $3,000 USD. [24]
Manufacturing setup:
Licencing costs to the manufacturing company will depend on the strength of the IP, device classification and regulatory status, and will be up for negotiation. Our test would be considered a high-priority test by WHO, which may increase the cost. Royalties received will vary and will be negotiated at the time.
Distribution setup:
This cost will be dependent on negotiations with the distribution partner.
Marketing:
Marketing costs are estimated to be around 8-12% of our revenue [25].
Intellectual property:
During our communication with Dr. Holland, we received a rough estimate of the cost structure involved in the IP process.
0 months: £7,000–£12,000 – Cost for drafting and filing a UK patent application, including search and examination requests and applicable hourly fees.
6–9 months: £500–£4,000 – Cost for reviewing the search and examination report.
12 months: £1,000–£3,000 – Professional fees for drafting and £5,000–£7,000 for official and filing fees for the PCT (or international) application. This stage is the final opportunity to make amendments to the document.
18 months: £500–£4,000 – Patent application is published and becomes available for examiners to reference against new applications. Review of the international search report and opinion from the International Searching Authority.
30 months: £10,000–£30,000 – Cost for filing patents in other countries (Europe, US, and 4–6 additional countries).
30+ months: Costs are determined by the examiners in each country where a patent is filed.
Estimated total cost for IP: £24,000–£60,000+
7 Year Plan:
Entrepreneurship Workshop Reflections:
As part of our entrepreneurship journey, one of our team members attended a workshop focused on demystifying entrepreneurship. This session broadened our perspective and challenged many of our assumptions about what it means to be an entrepreneur.
Key Takeaways:
Entrepreneurship and Business Ownership
We learned that being an entrepreneur does not necessarily mean founding a business. At its core, entrepreneurship is about identifying a problem and finding an innovative way to solve it. While many solutions eventually take the form of businesses, the mindset is what matters most.
The Reality of Business in the UK
A surprising fact from the workshop was that 99.2% of UK businesses are small-to-medium-sized enterprises (SMEs). Before the session, many of us assumed the figure would be closer to 30%. This showed us how skewed our perception is - we often interact with large, global brands like Apple, HP, or Starbucks, but they actually represent only a small fraction of the business landscape.
Skills of an Entrepreneur
In the early stages of a venture, entrepreneurs need clever improvisation - navigating uncertainty, pitching to different audiences, and building partnerships with limited resources.
As a project grows, more structured planning becomes essential. However, one of the biggest pitfalls is shifting entirely into a managerial mindset. The workshop stressed that maintaining an entrepreneurial spirit is vital for continued innovation, scaling, and resilience.
Why this mattered for us:
This workshop helped us see our iGEM project in a broader context. Our work on diagnostics is not just about building a product - it's about adopting an entrepreneurial mindset to solve a global health challenge. It reminded us that even as students, we can think and act like entrepreneurs by focusing on problems, solutions, and creative strategies.
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