1. Summary
Triagnostics is a low-cost, at-home fluorescence-based diagnostic for monitoring recurrence of triple-negative breast cancer (TNBC). We intentionally built both the science and the business together: the commercial model shaped engineering choices (e.g., cell-free for home use; fluorescence for quantitative value), and engineering realities grounded the business.
Our plan uses materials adapted from the iGEM Venture Creation Labs (VCL)- a global incubator that helps iGEM teams turn projects into startups. Shumvobi Mitra and Ulysses Matricciani previously participated (2024) and translated those lessons directly. Dylan Paoletti, Founder/CEO of a cancer therapeutics company, contributed commercialization insights to structure the roadmap.
Deliverables, interviews, and engineering validation (Arduino hardware workshops + stakeholder feedback) shaped the business plan end-to-end.
2. The Venture Creation Labs
2.1 Overview
This section covers how the team developed a business plan. The backbone of our business plan development is based on materials adapted from the iGEM “Venture Creation Labs” (“VCL”), an incubator program for iGEM teams to turn iGEM projects into companies. This is part of a larger track, called the “iGEM Venture Foundry”, consisting of the VCL, a week-long workshop called the Biohackathon, and a mentorship program, culminating in the startup showcase in the Jamboree. Two team members, Shumvobi Mitra and Ulysses Matricciani, attended this program in 2024 with a former iGEM project. Additionally, student entrepreneur Dylan Paoletti, Founder and CEO of a cancer therapeutics company, was one of the key team members involved in the project. These entrepreneurs have re-implemented the lessons they learned from the program and their businesses to develop the following plan.
Listed below are the VCL deliverables used to outline the team's business plan. Breakdown is given week-by-week. For reference, below is a link to a PDF containing the definitions for each deliverable, provided by iGEM VCL.
2.2 Week 1 Deliverables
2.2.1 Key Results (OKR)
2.2.2 Our Golden Circle Framework:
2.2.3 Unique Value Proposition (UVP):
Cellular machinery is harnessed to create a non-invasive at-home test, serving as the only diagnostic option designed for patients with recurrent breast cancer. This empowers breast cancer patients with accurate, easy monitoring– reducing clinic visits, improving comfort, and enabling earlier intervention.
2.2.4 Top Down Market Analysis:
2.2.4.1 Total Addressable Market (TAM) — $3–6B/year
- Cancer Diagnostics Market Size: According to Grand View Research (2025), the global cancer diagnostics market is projected to reach approximately $155.07 billion by 2030, growing at a compound annual growth rate of 6.14 percent.[1]
- Breast Cancer Global Statistics: The World Health Organization (WHO) reports approximately 2.3 million new breast cancer diagnoses occur globally each year.[2]
- TNBC Prevalence and Recurrence: The American Cancer Society states that TNBC accounts for 10 to 15 percent of breast cancer cases and has a recurrence rate of about 40 percent within five years.[3]
- Assumption on Monitoring Need: Based on comments from Dr. Zimmerman, it is reasonable to assume TNBC survivors would seek semi-annual recurrence monitoring.
- Final Calculation: Using a conservative pricing model of $50 to $100 per test annually, which we take from the price point of direct-to-consumer genetic tests like 23andMe, this yields a global market estimate of $3 to $6 billion per year for TNBC remission testing.
2.2.4.2 Serviceable Available Market (SAM) — $800M–1.5B/year
- Geographic Focus: The analysis focuses on the U.S., Canada, European Union countries, and India: regions with reliable cancer reporting systems and access to health infrastructure.
- Demographics: The Centers for Disease Control and Prevention (CDC) notes that TNBC disproportionately affects Black women and younger women in the United States. According to GLOBOCAN 2020 data from the International Agency for Research on Cancer, these regions account for a significant proportion of global breast cancer cases.
- Market Estimate: Across the U.S., Canada, EU, and India, there are an estimated 117,000 to 130,000 new TNBC cases annually [3-8]. With a 40 percent recurrence rate [9], this results in 46,800 to 52,000 new patients who may need monitoring, and a bigger population when you look at the number of TNBC patients in their first five years after initial diagnosis/treatment, the window in which recurrence is most likely. Assuming 50 percent uptake at $50 to $100 per test, the SAM is estimated between $800 million and $1.5 billion per year.
2.2.4.2 Serviceable Obtainable Market (SOM) — $80–400k/year
- Initial Reach: For early-stage rollout in North America, a realistic goal would be reaching 2,000 to 5,000 users within the first two years through partnerships with clinics, nonprofits, and local communities.
- Revenue Estimate: At a price of $40 per test and a usage rate of one to two tests per user per year, and a projected revenue would be between $80,000 and $400,000.
- Benchmarks: Synthetic biology diagnostics startups such as Sherlock Biosciences and Mammoth Biosciences provide reference points for user growth and regulatory strategy. With price points of $50-100, direct-to-consumer genetic and diagnostic companies like Color Genomics and 23andMe demonstrate that customers are willing to pay that much for at-home health tests.
2.3 Week 2–3 Deliverables
2.3.1 Pitch Deck
Provided is an initial version of our pitch deck- subject to review from the Head of iGEM startups herself. We will provide an updated version with her feedback after wiki thaw, and plan to mention key changes we made from her feedback during the 5 minute update.
2.3.2 Lean Business Model Canvas (LBMC)
The lean business model chart is a short snapshot into the most critical aspects of our business. It re-summarizes our problem statement and solution model, customer segments, revenue channels, and market channels.
2.3.3 Branding Deliverables
2.3.1.1 Major Platform(s)
- Facebook (lots of groups on this that we can target [Triple Negative Breast Cancer Foundation], our target audience is older which aligns with the demographic that uses this platform)
- Instagram (again there are groups on this platform that we can target [@tnbc_thrivers], this is also a platform that most of our team is likely more used to navigating)
- LinkedIn (while not primarily for reaching out to target patients, this platform offers a valuable way to reach out to clinics and professionals to spread our product and get more opinions to improve our product)
2.3.3.2 Voice of Your Brand
- This in our opinion , should be based on the platform/target audience.
- Facebook/Instagram - The tone should be formal, warm and welcoming, and informative. In some instances it may be helpful to have more of an inspirational, friendly, persuasive, and/or professional tone.
- LinkedIn - Since this platform is meant to target the more professional side of our stakeholders, it makes sense to match that with a professional, persuasive, informative, formal tone.
2.3.3.3 Visual Branding
2.3.4 Risk Assessment
2.3.4.1 Regulatory Approval Delays/Clinical Validation and Efficacy Concerns
Potential delays in obtaining FDA and other necessary regulatory approvals could prevent the product from reaching the market efficiently. Inability to produce strong clinical validation data demonstrating efficacy and accuracy could undermine market confidence and limit buyers. It is possible our tech may not work as intended.
2.3.4.2 Manufacturing & Scalability Challenges
Depending on the demand of the product, considering the limited space and resources at the lab, mass manufacturing may prove to be difficult.
2.3.4.3 Reimbursement and Payer Acceptance
Difficulty in obtaining coverage and reimbursement from private insurers, Medicare/Medicaid, or national health systems could limit patient access and impact financial viability.
2.3.4.4 Market Adoption & Competitive Response
Considering how common mammograms and other diagnostic tools are, it may be hard to get customers to switch to our device. Also, sustaining relevance through innovation is a concern.
2.3.4.5. Biomarker Specificity and Biological Variability
Tridentify relies on the detection of specific biomarkers to indicate the recurrence of TNBC. However, biomarker expression may differ across individuals due to genetic, environmental, or treatment-related factors. If our biomarkers are not consistently reliable across diverse patient populations, the test’s performance and credibility may be significantly impacted.
2.3.4.6. Perception and Credibility as an Emerging company
As a new and potentially student-led initiative, Triagnostics may face doubts regarding its legitimacy and readiness for clinical use. Without backing from well-known medical institutions or experienced leadership, stakeholders may hesitate to invest in or adopt our product, regardless of its scientific potential.
2.3.5 Protection Strategy
2.3.5.1 Regulatory Approval Delays
- Early engagement with regulatory consultants and former FDA reviewers to ensure a clear understanding of requirements and avoiding surprises.
- Pre-submission meetings with FDA to validate the planned clinical and technical approach.
- Parallel pathway strategy: apply for approvals in multiple jurisdictions simultaneously (FDA, CE Mark in EU, etc.,) to diversify regulatory risk.
2.3.5.2 Clinical Validation and Efficacy Concerns
- Partner with leading academic centers for well-designed, peer-reviewed clinical studies.
- Use interim data reviews to adjust study design in real-time if initial results show issues.
- Plan for publication in high-impact journals and present at major conferences to build credibility with the clinical community.
2.3.5.3 Manufacturing & Scalability Challenges
- Engage CMOs (contract manufacturing organizations) with experience in scaling medtech products.
- Implement Quality by Design (QbD) principles early in development to minimize future production variability
- Build a redundant supplier network for key components to avoid supply chain disruptions.
2.3.5.4 Reimbursement and Payer Acceptance
- Develop cost-effectiveness and budget impact.
- Initiate early discussions with major payers and CMS to understand reimbursement codes and coverage pathways.
- Partner with organizations that advocate for expanded access to diagnostics in underserved communities.
2.3.5.5 Market Adoption & Competitive Response
- Develop KOL (Key Opinion Leader) networks in oncology and primary care to drive early adoption
- Launch targeted educational campaigns to highlight Tridentify’s advantages over traditional methods
- Monitor competitive landscape and pursue strategic partnerships or IP protection (patents, trade secrets) to maintain differentiation
2.3.5.6 Biomarker Specificity and Biological Variability
- One way we could mitigate this issue is by working personability into our product. This indicates using specific miRNA that were found in someone’s initial TNBC diagnosis in order to best identify if they are in remission.
2.3.5.7 Perception and Credibility as an Emerging Company
- The way that this issue can be mitigated is by putting an emphasis on the credibility of our lab and the procedures we carried out as well as the credibility of our mentors as well as obtaining the recommendation of accredited people in the field.
Skills, Capabilities, and Stakeholders
3.1 Team Skills & Capabilities
The Baltimore BioCrew brings together a unique blend of scientific expertise and entrepreneurial drive. Our team is composed of student researchers, startup founders, and scientists working out of the Baltimore Underground Science Space (BUGSS). Together, we combine the technical ability to design and test synthetic biology tools with the vision and adaptability needed to bring innovations to real-world use. Learn more on our Team page.
3.2 Our Internal Capabilities
- ynthetic Biology & Diagnostics: Design and testing of toehold switches, miRNA biomarker identification, and assay development.
- Modeling & Design: RNA secondary structure modeling and the development of AND-gate logic for diagnostic accuracy.
- Startup & Business Development: Team members with direct experience in launching student-run ventures and nonprofit organizations, providing insight into business models, fundraising, and community engagement.
- Scientific Research: Hands-on experience in university labs and biotech settings, including spectroscopy, neuroscience, and molecular biology research.
- Human Practices & Outreach: Public engagement, patient accessibility initiatives, and stakeholder communication to ensure our diagnostic tool remains equitable and impactful.
While we bring many of the skills needed to design and develop our diagnostic platform, we recognize the importance of external expertise in areas such as regulatory affairs, clinical validation, and large-scale commercialization.
3.3 Product Shaping Stakeholders
To strengthen our project and increase credibility, we have reached out to experts in diagnostics, assay development, regulatory science, and biotech entrepreneurship. Their guidance helps us refine our approach, validate our design, and understand the real-world challenges of bringing a medical diagnostic to market.
- Dr. Viktor Adalsteinsson- Liquid biopsy and cancer (including TNBC) diagnostics: Dr Adalsteinsson gave feedback on liquid biopsy MVP design, and also provided examples of lateral flow tests for cancer diagnostics. Said that specificity is most important in screening tests → we learned that using an AND based toehold gate would be best for increasing specificity.
- Dr. Ally Huang , BioBits – Cell-Free Fluorescent Diagnostics: Providing insights into stabilizing cell-free systems, hardware-free designs, and scaling point-of-use diagnostics → we learned that it’s possible to make scalable and affordable tools for qualitative analysis of fluorescent proteins.
- Dr. David Garcia – Cell-free Systems Specialist from UMBC: Informed us on cell-free system principles and gave feedback on our cell free system → we learned that a cell free sensor would help as pass regulatory hurdles that are associated with live cell systems.
- Alan Grover - IT specialist who designed the code for STELLA-FS: provided insights on creating our arduino based device, and suggested a pharmacy-based commercialization plan → we learned how to build a low-cost alternative to a plate reader, functioning as quantitative tool for measuring fluorescence.
- Astek Diagnostics - high-speed liquid biopsy hardware design: informed us that small design details are very important, and also that we need “champions” in the field to advocate for our device → we learned that making a user friendly devise is just as important as creating one that is technologically sound.
Our next steps were to integrate this feedback into our business plan, regulatory roadmap, and product design, ensuring that our diagnostic test is both scientifically sound and commercially viable.
20 structured questions for patients, clinicians, biotech reps, and public health educators were developed. These guided product design, outreach strategy, and risk planning.
4. Product Development
4.1 Humble Beginnings
Our product development journey began with an exploratory phase where we examined multiple pathways for creating a low-cost, accessible diagnostic for triple-negative breast cancer (TNBC) recurrence. Early concepts prioritized simplicity and user familiarity, which led us to initially pursue a cell-based biosensor coupled with chromoprotein reporters. This design was intended to deliver a straightforward visual color-change output, interpreted either by the naked eye or through a smartphone app that could standardize and quantify results. However, as we progressed through engineering analysis, stakeholder interviews, and iterative venture design, we recognized significant limitations in this approach:
- Cell-based challenges: Maintaining living systems outside of controlled labs raised concerns about biosafety, regulatory approval, and supply chain complexity (e.g., stability, refrigeration).
- Chromoprotein challenges: Although conceptually simple, chromoproteins produced outputs that were heavily dependent on lighting conditions, user eyesight, and subjective interpretation. Older adults and underserved populations could face barriers to accurate use. Even with a colorimeter app, we heard doubts from stakeholders.
The need for a quantitative, user-friendly liquid biopsy test led to a shift.
4.2 Product Evolution
Based on these findings, and reinforced by feedback from our most influential stakeholders (see, section 3.3), we pivoted toward a cell-free fluorescence-based system, paired with a dedicated detection device. This evolution reflects a simple, but key principle in our product development process: taking in feedback from potential future users.
4.3 SWOT Analysis
4.4 Current Design
The finalized development pathway centers on a cell-free assay using toehold switch circuits to detect TNBC-specific miRNAs. This system offers multiple advantages:
- Safety and Stability Lyophilized, cell-free reagents are shelf-stable at room temperature and do not require specialized storage or handling.
- Quantitative output: Fluorescent proteins provide a reliable, measurable signal that can be quantified and integrated into the medical field.
- Regulatory alignment: Cell-free diagnostics have a clearer pathway for regulatory approval compared to live-cell systems.
To make this signal practical for at-home users, we designed a simple arduino based device. More information about this can be found on our contribution page.
By integrating these lessons, our current MVP delivers on both scientific credibility and patient empowerment, while maintaining a clear path to scalability and regulatory approval.
4.5 Statement of Cost
We understand that the combination of a cell-free diagnostic paired with a reporter option requiring specialized equipment will drive up the cost considerably. Our team has thought about this deeply. We are currently investigating several ways to bring down the cost. These include:
- Methods described to us by Dr. Garcia to use a cell-free system and to make our cell free system component cheaper. Suggestions centered primarily around reducing energy cost, and utilizing lyophilization.
- Coordinating with NASA STELLA to perfect our prototype fluorescence reader (see our Contribution section).
We want to clearly state that we cannot solve every issue in a singular summer. Even if this test itself is expensive, it’s going to be cheaper and faster than having to schedule a doctor’s appointment, pay for a possibly traumatic exam, schedule an actual test, wait for those results, wait for a doctor to interpret them, and then wait for a potentially life-changing phone call or email. We can eliminate months of stress and cancer growth with our product, which will overall come at a lower price relative to the traditional process.
4.5. Timeline
4.6. Exit Strategy
Broadly speaking, we want to patent our technologies, conduct clinical trials, and get FDA approval. From that point, we will commercialize (see Pilot, above), and, in our third or fourth year of business (2027–2028) we will institute a full or partial management-buyout (MBO), and/or licensing agreements.
We think this strategy is best, as with our current experience levels, we will need to rely on a strong advisory board. We can use a guarantee-of-MBO during recruitment of managers to ensure we get the most skilled candidates, without sacrificing early startup funding towards salaries.
While a company-company acquisition could be a perfectly viable strategy, the ethical implications aren’t appealing for us. Doing this would effectively lock in the entire market for TNBC recurrence testing into a large company, which could lead to stagnation in innovation.
This way, Triagnostics can stay an independent and ethical company.
5. Long-Term Impacts
5.1 Positives
- Novel use of fluorescence in at-home testing: Fluorescence is widely used in laboratory diagnostics but rarely applied in home-use devices, which typically rely on colloidal gold for simple yes/no readouts. By integrating fluorescence, Triagnostics delivers a more advanced and quantitative solution.
- Clinician-validated choice: Feedback from Medical Oncologist Dr. Zimmerman emphasized that physicians prefer quantitative results for recurrence monitoring. Among our options we selected fluorescence as the most clinically informative and scalable.
- Patient empowerment with quantifiable results: Traditional clinical reports often give patients vague feedback (“your levels are high”) without showing them meaningful data. Our system allows patients to directly visualize their results while preserving physician oversight, bridging the gap between autonomy and clinical integration.
- Platform adaptability: Since miRNAs used in our test are implicated in multiple cancers, our system is inherently adaptable. It can be extended to other cancer types or fine-tuned with additional TNBC-specific biomarkers, offering both breadth and precision in future applications.
- Sustained, at-home recurrence monitoring: Patients who have been declared cancer-free can still monitor themselves without waiting for an appointment, a critical feature of our B2C strategy that promotes ongoing vigilance and peace of mind.
- Reduced healthcare burden: For hospitals and labs, our test offloads the demand for repeat blood draws and lengthy follow-ups. Clinicians only need to interpret results rather than schedule and process every diagnostic cycle, reducing delays and enabling faster treatment interventions.
5.2 Negatives
- Risk of over-reliance: Patients may lean too heavily on the convenience of our test and use it as a substitute for official, more comprehensive diagnostic follow-ups with their doctors.
- Potential biomarker ambiguity: While recurrence is the most likely cause of TNBC-related miRNA upregulation, these signals can overlap with other cancers. Patients may overlook alternative diagnoses if results are not contextualized properly.
- Market precedent for pricing: As the first product of its kind, our test sets an initial benchmark cost. Other companies could reference this pricing to justify high costs for similar diagnostics, influencing affordability across the broader market.
- Stagnation in TNBC recurrence testing: s outlined in our LBMC “unfair advantage”, once we patent our AND-gate and toeholds, we have something virtually impossible to replicate. This means from a profit perspective, either we or possibly a company which acquires us has no incentive to innovate further.
References:
1. Grand View Research. (n.d.). Cancer diagnostics market size, share & trends (2025–2030). Retrieved October 7, 2025
2. World Health Organization. (14 August 2025). *Breast cancer* [Fact sheet]. Retrieved October 7, 2025
3. American Cancer Society. (June 25, 2025). *Triple-negative breast cancer* [Web page]. Retrieved October 7, 2025
4. Kulkarni, A., Kelkar, D. A., Parikh, N., Shashidhara, L. S., Koppiker, C. B., & Kulkarni, M. (2020). Meta-Analysis of prevalence of Triple-Negative breast cancer and its clinical features at incidence in Indian patients with breast cancer. JCO Global Oncology, 6, 1052–1062.
5. SURPASS-TNBC - European Partnership for Personalised Medicine - EP PeRMeD. (2025, February 5). European Partnership for Personalised Medicine - EP PerMed.
6. Breast cancer statistics. Canadian Cancer Society.
7. Breast Cancer Facts & Stats 2025 - Incidence, age, survival, & more. National Breast Cancer Foundation.
8. Inampudi, P., Yadlapalli, D. C., & Gullipalli, M. (2024). Clinicopathological profiles of and patterns of recurrence in Triple-Negative breast cancer patients at a cancer care center in southern India. Cureus.
9. Stewart, R. L., Updike, K. L., Factor, R. E., Henry, N. L., Boucher, K. M., Bernard, P. S., & Varley, K. E. (2019). A Multigene Assay Determines Risk of Recurrence in Patients with Triple-Negative Breast Cancer. Cancer Research, 79(13), 3466–3478.