Our mission

Our mission is to redefine sexual healthcare through innovation - bringing reliable, affordable STI testing from the lab to the hands of everyone who needs it.

The Problem

Customer and Unmet Needs Analysis

Target Customers

Our product is designed for sexually active individuals, independent of age, gender, sex, or sexual orientation. Specifically, the following groups are relevant:

  • Sexually active people: people who are sexually active, including those who want reassurance in new partnerships or before intercourse.
  • At-risk groups for Syphilis: individuals exposed to blood (e.g., through shared needles).
  • Geographies: Switzerland and international markets, including low-resource settings where PCR testing or checkpoints are unavailable.

Based on our interviews and analyses, we identified four main customer groups, which may overlap with each other:

  1. Time-constrained users – people who want fast access and quick results without waiting for an appointment.
  2. Availability-constrained users – people who lack local access to testing centers or doctors.
  3. Doctor-averse users – people who avoid medical settings due to stigma, fear, or desire for anonymity.
  4. Money-constrained users – people who cannot afford current tests at checkpoints, clinics, or private providers.

Customer Needs

Clinicians and Health Agencies (MVP Phase)

  • Ability to order and use tests in large quantities.
  • Distribution to low-resource settings without requiring a cold chain.
  • Easy to administer (though professional support is available if needed).
  • Fast readout (less than 30 minutes) to provide results and treatment during the same appointment, eliminating the need for follow-up travel for treatment receival, saving time and money.

Time-Constrained Users

  • Short overall process: from obtaining the test to receiving the result.
  • Fast readout (under 30 minutes).
  • Tests should be available in supermarkets, vending machines, and online.
  • Storage at room temperature for at least 3 months (ideally longer).
  • Simple handling, no extra equipment, possible to use outside of home.

Money-Constrained Users

  • Low price point compared to current PCR tests (priced at 100–300 CH in Switzerland [1]).
  • No need for extra equipment or infrastructure.

Availability-Constrained Users

  • Tests must be consistently available, without long shipping times.
  • No dependence on medical staff, avoiding issues of personnel shortages.
  • Accessible at or near point-of-need, e.g. at supermarkets, vending machines, pharmacies.
  • Shipping and long-term storage without the need for a cold chain, reducing costs for logistics.

Doctor-Averse Users

  • No need to visit a doctor for testing (although treatment still requires medical support).
  • Anonymous or discreet pathways for guidance and follow-up after a positive result.

Unmet Needs in Current Solutions

  • Cost barrier remains unsolved: Current options (lab samples, PCR at doctor/checkpoint, commercial tests) are expensive.
  • Time and availability issues: No rapid access in vending machines or supermarkets in Switzerland; delays remain due to appointments and lab turnaround times.
  • Sample-to-lab models: create both money and time problems.
  • Doctor visits/checkpoints: add barriers of cost, waiting, availability, and stigma.
  • Existing at-home self-tests: only partially solve time and availability issues; no fully accessible, affordable, and reliable solution exists.

This is also displayed in the following table:

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Table 1: Overview of unmet needs in current STI testing solutions, highlighting existing barriers in cost, accessibility, and reliability.

Our solution

Business Model Canvas

The Business Model Canvas is a strategic tool that visualizes how a company creates, delivers, and captures value. It outlines key components such as customers, value propositions, channels, revenue streams, and partnerships in a single, easy-to-understand framework.

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Table 2: Our Business Model Canvas

Customer Relationships

Our approach to customer relationships is tailored to each segment, balancing accessibility, scalability, and resource efficiency.

Consumers (At-Home Use)
We emphasize self-service through our website, where users can easily order and perform the test with minimal intervention. Comprehensive instructions, tutorials, FAQs, and info boxes ensure smooth use while keeping resource demands low. Overall, interactions are primarily automated and digital, allowing us to scale effectively without requiring a large support team.

Clinics and Low-Resource Settings
We provide a single point of contact for inquiries and offer short, standardized training modules for health workers, delivered digitally (e.g., videos or slides). This minimizes the need for active, ongoing support. The focus is on modular, easily replicable resources, avoiding costly on-site training programs while ensuring consistent implementation.

Customer Relationships

Our approach to customer relationships is tailored to each segment, balancing accessibility, scalability, and resource efficiency.

NGOs and Public Health Agencies
Relationships with NGOs are built on partnership and co-development, enabling collaboration on awareness campaigns or pilot programs. Communication is maintained through regular updates, newsletters, or virtual meetings, ensuring collaboration remains structured, predictable, and resource-efficient. Most interactions are designed to be remote and scalable while still enabling meaningful impact.

Pharmacies and Retailers
Engagement with pharmacies and retailers is largely transactional, based on bulk supply agreements. To support adoption and visibility, we provide standardized training materials and promotional guidance (e.g., brochures, videos), replacing the need for extensive in-person staff training.

Key Activities

Our key activities span the entire lifecycle of developing, producing, and delivering an accessible diagnostic test. At the foundation, we focus on company setup, fundraising, and intellectual property management to ensure long-term viability and protection of our innovations. Central to our operations is research and development, where we drive test design, development, and continuous optimization. Alongside this, we prioritize regulatory compliance, securing certifications such as CE marking to guarantee safety and reliability.

To support usability and accessibility, we invest in digital infrastructure, including a website for ordering and online tutorials to guide customers. On the production side, we oversee manufacturing, quality control, and scaling of production to meet growing demand. Complementing this is supply chain management and logistics, ensuring efficient procurement, distribution, and discreet delivery.

Externally, we build strong visibility and adoption through marketing, outreach, and partnerships with clinics, NGOs, pharmacies, and retail outlets. Finally, we maintain a focus on the user experience through customer support and trust-building, offering clear tutorials and discreet packaging to foster confidence and encourage widespread use.

Channels

Our company will establish communication and sales channels. With the right communication, we will convey the added value to our prospective customers. At the same time, it is the key to contacting investors and conveying our concept clearly and correctly. Specifically, we are focusing on collaboration with NGOs and health organizations as well as awareness events and social media. In addition, we want to distribute our product on two levels: B2B (Business to Business), by acquiring health centers and pharmacies as customers, and directly to end customers via an online store (B2C; Business-to-Consumer).

Key Resources

We draw on various resources that we have or will have in the course of our development. First and foremost are the knowledge and experience our team already possesses and continues to develop through iGEM. This includes experience in the laboratory, as well as in organization and coordination. Certain skills are not yet covered by our team, so we plan to outsource specific tasks or bring suitable employees on board.

An important resource we have is our testing method, developed during iGEM, which is at the heart of our product and startup. To continue developing this test method into a marketable product, we require laboratory space and materials. Another key resource is stakeholder and customer feedback, which we will integrate into development to adapt our product to market needs and expectations.

To make all this possible, we depend on funding from investors and organizations. This is an essential part of our resources and a challenge we will address early in our company’s growth, as described in the “Financing” section.

Cost Structure

Our costs are incurred in several areas. The largest share is research and development (R&D), including personnel costs, materials for experiments, and expenses related to intellectual property (IP) and regulatory compliance. We also invest in scaling up from a functioning laboratory test to a marketable, scalable product. This includes improving shelf life through freeze-drying and verifying that there are no health risks for users.

We plan to outsource the production of the finished test, including packaging, to an experienced contract manufacturer with established facilities and machinery. Marketing costs are also a significant part of our cost structure, as appealing materials such as videos play a major role in user engagement and visibility.

Value Proposition

Our diagnostic platform offers a low-cost and rapid solution for detecting infectious diseases. It is multiplexed, enabling the simultaneous detection of up to five pathogens within a 30-minute readout time. The system is designed for full privacy and at-home use, combining accessibility with high performance. This approach makes reliable molecular testing available to everyone, without the need for specialized equipment or clinical supervision.

Key Partnerships

In the early stages, our project will collaborate with a university lab for wet lab support, business and startup experts for strategic guidance, and a manufacturer for scale-up production. We will also work with clinics and checkpoints for point-of-care test deployment and with the City of Zurich within its STI program.

At later stages, partnerships will expand to include legal advisors for Swiss market approval, distribution partners such as Selecta vending machines and major retailers (Migros, Coop), and a referral network of clinics, doctors, and psychologists to provide post-test support.

Revenue Streams

Our revenue model is designed to evolve alongside the development and expansion of our product. In the short term, we aim to generate income through partnerships with clinics and test centers conducting pilot programs and initial product evaluations.

In the medium term, revenue will come from direct sales to consumers in Switzerland and through subscription-based packages that ensure continuous access to our testing solutions. In parallel, we plan to establish B2B partnerships with clinics, pharmacies, and health organizations to broaden our customer base and strengthen market presence.

In the long term, our focus will shift toward collaborations with NGOs and global health initiatives to enable broader distribution in low-resource settings, supporting global access to affordable and reliable diagnostics.

Minimum Viable Product (MVP)

Our minimum viable product (MVP) is defined as follows:

To first test the feasibility of the product and collect important data on usability, the test will initially be implemented as a point-of-care (POC) test. This allows evaluation in a controlled setting with medical staff present. It also aligns with current Swiss regulations: at present, self-sampling is not permitted except in specific cases (e.g., HIV and COVID-19 tests). However, according to the BAG, the Federal Office of Public Health, these regulations are expected to change in the coming years, potentially opening the door for broader self-sampling use.

For the MVP, we will focus on a single pathogen: Syphilis. This decision was based on interviews with Checkpoint Zurich (CPZH) and AIDS Hilfe Schweiz, who both emphasized the strong need for a Syphilis self-test or at least a reliable POC option. The test must demonstrate high specificity and sensitivity while functioning reliably at room temperature. Its quality and stability will need to be validated through certified clinical studies.

As a point-of-care (POC) test for syphilis, the MVP will primarily compete with current standards such as PCR tests, which typically cost between 100 and 300 Swiss Francs in clinics, test centers, or doctors’ offices [1]. To offer a viable alternative, our test must be significantly more affordable. By reducing labor and material cost we can offer the diagnostic service at a substantially lower price. The time to result must be a maximum of 30 minutes to fit within a doctor’s appointment. Both CPZH and AIDS Hilfe Schweiz highlighted this requirement. This product goal fits customer expectations as well as 53% of our survey participants would wish for results within this time frame.

Our MVP product will contain following contents in the packaging:

  • Test device
  • Finger-prick tool for blood sample
  • Instructions for use and post-diagnostic steps
Function MVP Switzerland Full Product
HPV No Yes
Syphilis Yes Yes
Chlamydia No (already exist on its own + POC also) Yes
Trichomonas No (already exist on its own + POC also) Yes
Gonorrhoea No (already exist on its own + POC also) Yes
Freeze drying Yes Yes
Lateral flow Yes Yes
Time to readout Short (<30 min) Short
Work temperature Room temp (in the patients room) Room temp
Storage conditions Needs to be stable at room temperatures for some time, but storage in a fridge in the clinic is acceptable At room temp for at least 3 months
Cost Rather low Low
Specificity High (almost like PCR) High
Sensitivity High (almost like PCR) High
Readout (color, etc.) Fluorescence / Color Color
Simplicity of usage Rather easy (POC) Very easy
Urine sample No Yes
Blood sample Yes (Syphilis) Yes
Swab sample No Yes (other STIs)
Target use setting Clinic (current regulations) At-home, low resource setting, clinic
Equipment strip, buffer, maybe readout device) No additional (all in the package)
Table 3: Comparison of functional features between the MVP version for Switzerland and the full product version, illustrating differences in target pathogens, usability, and operational requirements.

SWOT

To assess our idea beyond initial concepts, we conducted a SWOT analysis. This approach enabled us to clearly map our strengths and weaknesses, while also identifying external opportunities and potential threats that could impact the development of our MVP (minimally viable product).

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Table 4: SWOT analyis

Strengths (internal)

Cheap / Low-Cost
A significant strength of at-home STI testing is its potential to reduce the financial barriers to screening. At-home kits can be a cost-effective alternative to clinic-based testing, especially for individuals without health insurance or those who face high copays for specialist visits. In Switzerland, the cost of a clinic visit can range from 100 to 300 Swiss Francs (124 to 372 USD, exchange rate of 27.08.2025) for a comprehensive STI test[1]. Mail-in PCR test kits do not perform a lot better in this regard, and also fall within this price range. Our product can be offered at a substantially lower price by reducing the cost of labor, materials, and logistics. A key factor in achieving this cost advantage is the test’s independence from cold-chain requirements.

Easy Transportation and Minimal Infrastructure
Our test is small and lightweight, making it easy to transport and convenient for end-users. This not only benefits individual users but also simplifies large-scale distribution, facilitates outreach programs in rural or underserved areas, and enables delivery by mail without special handling by eliminating the need for cold-chain storage. Our test is fully self-contained and does not depend on any external infrastructure. Users can complete it anytime and anywhere, without the need to send samples to a laboratory or rely on cold-chain storage.

Speed
With results available in under 30 minutes, our test provides immediate feedback that offers peace of mind and enables faster action—a significant public health advantage. Additionally, unlike testing at health centers, it eliminates waiting times altogether.

Privacy and Convenience
Through at-home sample collection and readout, discreet packaging, and online ordering, our test maximizes privacy and convenience. These features help lower many of the barriers that typically prevent individuals from accessing STI testing.

Multiplexing
The ability to screen for multiple STIs from a single sample represents a major technical and clinical advantage. Multiplexing enables the simultaneous detection of diverse pathogens, including bacteria (e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis) and viruses (e.g., HPV). This comprehensive approach is more efficient and valuable than a series of individual tests, as it streamlines the process, minimizes the discomfort of repeated sample collections, and helps identify co-infections that might otherwise remain undiagnosed. By integrating multiplexing, the test evolves from a basic screening tool into a robust diagnostic and public health instrument. Given that many STIs are asymptomatic and co-infections are frequent [2], a multiplexed test represents a more clinically sound and proactive solution.

Potential for Professional and Consumer Market
The test is designed for flexibility: it can be used privately for self-testing or in clinics as a point-of-care diagnostic. Especially in resource-limited areas, point-of-care use could provide critical access to STI testing. In industrialized countries, there’s also demand for POC STI self-tests, particularly for Syphilis.

Weaknesses (internal)

Accuracy
While PCR remains the gold standard due to its very high sensitivity and specificity, it requires laboratory infrastructure, precise temperature cycling, and trained personnel. In contrast, RPA enables isothermal amplification at constant, low temperatures (around 37–42 °C), making it faster, simpler, and more suitable for point-of-care or self-testing. Although RPA-based tests may slightly underperform PCR in absolute sensitivity, their speed, ease of use, and equipment-free workflow make them highly advantageous for decentralized diagnostics.

Durability
The physical and chemical stability of the test components is another weakness. The effectiveness of the test's reagents can degrade over time, which is why it is crucial to use kits before their expiration date. A limited shelf life presents a logistical challenge for manufacturers in managing inventory and for consumers who may purchase a kit and not use it promptly. Exposure to extreme temperatures during shipping or storage can also compromise the integrity of the test components.

Contamination
Contamination refers to unwanted genetic material entering the test, potentially causing false positives. It is mainly a WetLab issue addressed through clean manufacturing and sealed reagents, whereas user error stems from incorrect handling during self-testing.

Qualitative Readout
Our STI test delivers a qualitative result: a simple positive or negative outcome. This format is ideal for initial screening and rapid decision-making, allowing users to identify potential infections quickly and discreetly. However, it is not designed for continuous disease management, as it does not measure quantitative indicators such as viral load. For follow-up or treatment monitoring, users would still rely on confirmatory laboratory diagnostics.

User Error Risk
A key challenge of at-home diagnostic tests is that they rely on users without professional training to collect samples accurately. Mistakes in sample collection—such as not inserting a vaginal swab to the proper depth or using insufficient blood volumes—can result in inaccurate results or samples deemed inadequate. Studies show that approximately 2–4% of samples are inadequate, with blood samples proving to be most difficult[3].

Opportunities (external)

Growing STI Incidence
Sexually transmitted infections (STIs) represent a growing public health challenge worldwide [4]. This growing burden highlights the urgent need for better, more accessible screening options. Our project responds directly to this need by providing a simple, reliable, and user-friendly testing method that lowers the barrier to getting screened.

Integration into Current Processes
We envision a system that integrates directly into existing healthcare pathways, ensuring that testing is not an isolated event but part of a continuum of care. This could include anonymous digital referrals to local clinics, telehealth consultations, or hotlines that offer both medical guidance and emotional support. Such integration encourages individuals to not only get tested but also seek treatment when needed. Visit our Product page to see how we have already implemented this.

Application Beyond STIs
While our initial focus lies in improving STI diagnostics, the underlying detection system is highly versatile and can be expanded to many other areas:

  • Other infectious diseases: Rapid and accessible detection of pathogens such as influenza, COVID-19, or gastrointestinal infections.
  • Antimicrobial resistance (AMR): Identifying resistant bacterial strains quickly at the point of care to guide effective treatment choices.
  • Cancer biomarkers: Early, low-cost screening for certain cancers through molecular detection of specific DNA markers.[5]
  • Veterinary medicine: On-site testing for livestock, such as detecting mastitis in dairy cattle or avian influenza in poultry, where early identification prevents outbreaks and economic losses.[6]
  • Agriculture: Rapid detection of plant pathogens that threaten food security, such as fungal infections in crops.
This broad applicability positions our technology as a platform for diagnostics, with potential to expand from human health into veterinary and agricultural domains. By starting with STIs—a clear unmet need—we establish proof of concept, and from there, the technology can scale to multiple sectors.

Riding the Health Trend
The rise of wearable devices, health apps, and personalized medicine reflects a growing trend: consumers want greater control over their health and well-being. At the same time, barriers to in-person testing remain high. Our Survey data reveals that many individuals do not get tested, but would consider testing if a self-test option was available. At-home testing addresses concerns of cost, privacy, and convenience by providing a solution that is private, immediate, and empowering. It allows individuals to take the first step towards diagnosis in the comfort of their own home. When paired with seamless integration into healthcare systems, it also ensures that this first step leads smoothly to treatment and support.

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Figure 1: Level of Consideration for Using STI Self-Tests of occasionally, once or never tested Participants.

Public Health Partnerships: B2B2C Models
Collaborating with public health departments and non-profit organizations represents a major opportunity to scale and reach underserved populations. Several programs across the U.S. have already demonstrated the success of this model, where state and local health departments partner with testing providers to offer free or low-cost kits to residents. Examples include the Alabama Department of Health, GetCheckedDC, and initiatives like Together TakeMeHome and I Want The Kit (IWTK). These partnerships offer a B2B2C (business-to-business-to-consumer) model that provides a direct channel for reaching at-risk individuals, increases testing uptake, and fulfills a critical public health mission. For a company, this strategy provides a stable revenue stream from government contracts while simultaneously building brand recognition and social trust.

Threats (external)

Competition
The at-home STI testing market is becoming increasingly crowded with a diverse range of competitors. Established players like Everlywell, LetsGetChecked, and myLAB Box offer comprehensive mail-in lab panels, while innovative startups like Testmate Health are developing instant, lab-equivalent PCR technology for at-home use. These companies differentiate themselves through various business models, pricing strategies, and service offerings, such as free physician consultations or same-day treatment options. The presence of these competitors, each with its own technological and strategic advantages, presents a significant threat to a new entrant's market share and profitability.

Regulatory Hurdles
The path to market for an at-home diagnostic device is complex, time-consuming, and expensive, requiring adherence to multiple regulatory standards, clinical validation, and certifications before launch. This can delay market entry and increase development costs.

Competition analysis

Competitors:

To identify our competitors, we divided the tests on the market into different categories. Using several criteria, we determined whether the products represent direct, indirect, or future competition for us. We took a closer look at the direct competitors and analyzed their products in greater depth.

Direct competitors are those who offer a similar product that can be used by end users, does not need to be sent to a laboratory, and delivers a result within minutes. We found three companies that we consider our direct competitors:

Touch Australia offers a rapid test for chlamydia and gonorrhea with good sensitivity and specificity, but it is designed only for women. Our test would make it possible to test for chlamydia, gonorrhea, syphilis and HPV in a single test and is suitable for both men and women.

Get tested offers tests for all relevant pathogens and also provides multiplex tests. Unfortunately, we could not find information on specificity and sensitivity online, and we did not receive a response to our email requesting further details.

De Tester B.V. offers tests for syphilis, HIV, chlamydia, and Candida.Prices as well as sensitivity and specificity are competitive. However, the tests are not multiplex-capable, so end users would have to take multiple samples, which is impractical and can increase the risk of failure. In addition, the chlamydia test is only intended for women, which is not ideal. In general, all the tests allow only one sample type to be collected, which fundamentally lowers the chances of success. Our test will work with multiple sample types such as blood, urine, and swab, which significantly increases the success rate.

Indirect competitors are those that offer good tests but require samples to be sent to a laboratory to obtain results. This is less anonymous than an at-home rapid self-test and takes a lot of time.

Future competitors are those that have the potential to develop a reliable test for self-testing diagnostics. This includes, for example, rapid tests that can currently only be performed by professionals. These tests are designed to deliver quick results and to work without expensive laboratory equipment. They could become our competitors in the future if regulations change or the tests become easier to perform. An example of such a potential future competitor is the German company möLab GmbH.

The market

The global market for STD self-testing is expanding rapidly, driven by rising infection rates and growing consumer demand for privacy and convenience in healthcare. In 2024, the market was valued at approximately USD 1.21 billion and is projected to reach USD 1.98 billion by 2030, reflecting a compound annual growth rate (CAGR) of 8.75% [7]. Online distribution channels have shown the fastest growth, highlighting the shift toward digital accessibility [8].

Market Drivers
Several key factors are fueling the growth of the STD self-testing market:

  • Rising Incidence of STDs: Increasing global infection rates are creating strong demand for accessible testing solutions. In the U.S., for example, syphilis cases rose by nearly 80% between 2018 and 2022, increasing from 115,000 to 207,000 according to the CDC [8]. As awareness of early detection grows, the need for reliable self-testing kits is expected to rise.

  • Privacy and Convenience: Many consumers prefer at-home testing options that allow discreet and easy sample collection.

  • Technological Advancements: Innovations in rapid diagnostic technologies have improved test accuracy, reliability, and user experience, further driving adoption (7).

Types of Tests
By sample type, the STD self-testing market is segmented into blood-based, urine-based, and oral-based tests [8].

Blood-based tests dominate the market with a 57.2% share in 2024. Their precision, reliability, and broad acceptance in both clinical and home-use contexts make them the preferred option, especially in developed markets where consumers prioritize high-quality diagnostic tools.

Regional Insights

  • North America: Leads the global market with 33.4% of revenue in 2024, supported by strong awareness and widespread adoption of at-home testing. [7]
  • Asia-Pacific: Expected to be the fastest-growing region, driven by rising STI incidence and improved healthcare access. [7]
  • Europe: Maintains a significant market share, boosted by strong government support, investment in rapid diagnostics, and research initiatives [8].

Outlook

The STD self-testing market is set to continue expanding as awareness grows, regulations become more supportive, and technological innovations make tests more accessible. Increasingly, self-testing is being recognized not only as a convenient tool for personal health management but also as a way to reduce pressure on clinical testing facilities [7].

Our Vision

Go-To-Market Strategy

Distribution Channels

Our product will be distributed through a multi-channel strategy to ensure accessibility for different customer segments and rapid scalability from launch.

Online direct-to-consumer (D2C) sales will be introduced first, allowing users to order tests discreetly with neutral packaging and privacy-focused delivery. Transparent communication, visible certifications, and a professional medical design will help build trust and confidence in test accuracy.

A few months later, clinics and testing centers (e.g., Checkpoint Zurich) will join as partners for clinical validation and performance demonstration, further strengthening credibility. Pharmacies and selected retailers will subsequently expand accessibility and help normalize regular STI testing in everyday healthcare. Collaborations with NGOs and public health agencies will support outreach and equitable access across different population groups.

Key Partners and Distributors

Key partners will include:

Key Partnerships

Key partners will include:

  • Clinics and Checkpoints (e.g., CPZH): Early implementation partners for pilot testing, data collection, and validation in real-world settings.
  • Pharmacies, healthcare retailers, and vending machine operators: B2B distribution partners once self-testing is permitted, improving accessibility by placing tests in everyday, easily reachable locations.
  • Public institutions: Raising STI testing awareness is already a national health priority in Switzerland [9]. The government acknowledges the high rate of asymptomatic STIs and supports prevention initiatives — for instance, Zurich offers free STI testing for people under 25 through a pilot project [9]. Collaborating with these institutions enables alignment with ongoing national health campaigns, amplifying awareness and social impact.
  • NGOs and public health agencies (e.g., AIDS Hilfe Schweiz): Ideal partners for pilot programs, awareness campaigns, and outreach to underserved populations — including young people, migrants with language barriers, sex workers, and residents in remote areas — who are often less reached by traditional healthcare services.
  • Health insurance providers: Strategic partners in our go-to-market plan. Regular STI screening is both a public health and financial priority, as untreated infections can lead to severe and costly long-term complications [10]. Examples include:
    • Chlamydia: Around 10% of untreated infections progress to pelvic inflammatory disease (PID), potentially causing infertility, ectopic pregnancy, and chronic pain (10). Screening can reduce PID incidence by up to 60% [11].
    • Syphilis: 25–40% of untreated cases progress to tertiary disease after 20–30 years (12).
    • Neurosyphilis (5–10%): Causes late neurological complications such as tabes dorsalis, Charcot spine, and syphilitic paresis (dementia paralytica) [4].
    • Cardiovascular syphilis (~10%): The most common tertiary form, typically developing after 10–30 years; can result in aortic aneurysms, “tree-bark” aortitis, heart failure, and elevated myocardial infarction risk [12].
    The majority of these infections are asymptomatic, leading to low testing rates and a high likelihood of long-term complications remaining undetected until it is too late. Investing in awareness and promoting regular testing would therefore be highly beneficial for insurers, as it can significantly reduce costly downstream treatments through early detection and prevention. Supporting regular testing can lower future healthcare expenses, similar to how many Swiss insurers subsidize fitness memberships [13] to prevent chronic diseases. By collaborating with insurers, we aim to integrate STI testing into existing preventive health frameworks, co-develop awareness campaigns, and potentially offer cost coverage or incentives for regular testing. This aligns public health goals with economic interests and could significantly accelerate adoption.
  • Contract manufacturers: Ensure reliable, scalable, and high-quality production that meets regulatory standards and supports both pilot and commercial phases.
  • Logistics partners: Enable discreet, efficient, and temperature-stable shipping solutions for both clinics and private consumers, ensuring accessibility and user trust.

These partnerships ensure technical credibility, broad distribution, and effective awareness-building across multiple levels of society - from clinics to consumers, and from NGOs to insurers and public health institutions.

Building Trust

Trust will be built through rigorous clinical validation in collaboration with Swiss clinics and Checkpoints, ensuring our product meets high sensitivity and specificity standards (>99%). We will emphasize transparent communication of performance data and regulatory approvals, including CE marking, the European conformity label that certifies compliance with stringent safety, health, and performance requirements for in vitro diagnostic devices. This certification is essential for entering the Swiss and European markets and serves as a strong quality signal for customers and stakeholders. [14]

For consumers, discreet packaging, clear instructions, and privacy-focused online ordering will be key. Partnerships with trusted NGOs and clinics further strengthen public confidence and facilitate early adoption.

Blue Ocean Strategy: Shifting Buyer Groups from Doctors to Patients

In addition to leveraging existing clinical and pharmacy distribution channels, we are deliberately pursuing a Blue Ocean Strategy by shifting the buyer group from physicians and health centers to end consumers through direct-to-consumer (D2C) sales. Rather than competing solely within the established B2B diagnostic landscape, dominated by doctors, clinics, and testing centers, we target patients directly, enabling them to access high-quality STI testing without intermediaries.

This approach, including the example of Novo Nordisk’s pioneering strategy in the insulin market, was suggested by a financial expert who wishes to remain anonymous. According to this expert, Novo Nordisk successfully shifted insulin administration from physicians to patients by introducing user-friendly insulin pens, a strategic move often described as a Blue Ocean shift. By focusing on patients’ needs rather than physicians’, Novo Nordisk made the solution more convenient and accessible for end users.

Similarly, by providing anonymous, discreet, at-home testing options through online channels and retail partners, we enable individuals to conduct STI tests privately, bypassing the need to visit a doctor. This is particularly relevant for sexually transmitted infections, which are often asymptomatic, therefore, complementary awareness initiatives will be essential to drive adoption and encourage regular testing.

By shifting the focus from healthcare providers to patients as the primary buyer group, we unlock a previously underserved segment and normalize self-directed STI screening as part of personal preventive healthcare.

Development & Scaling Plan

1. R&D Phase

Goal: Develop a robust, clinically validated diagnostic test for Syphilis (MVP).

Activities: Core assay development, freeze-drying optimization, and initial usability studies with clinicians.

Risk Assessment:

  • Scientific: Assay fails to meet sensitivity/specificity targets → iterative optimization and external lab validation.
  • Regulatory: Delays in Swiss self-testing regulations → focus first on clinical validation and point-of-care compliance.
  • Financial: High R&D costs → phased fundraising through grants and early investors.
  • Operational: Limited in-house manufacturing → partner with experienced contract manufacturers.

2. Clinical (Pilot) Study (POC Validation)

Goal: Conduct a formal clinical study in collaboration with Swiss clinics and Checkpoints to validate test accuracy, usability, and workflow under real-world conditions.

Activities:

  • Implement the study with clinical partners such as Checkpoint Zurich and other testing centers.
  • Collect and analyze data on diagnostic performance (sensitivity, specificity), user handling, and workflow efficiency.
  • Use study results to refine packaging, user instructions, and overall product design before commercial rollout.

Risk Assessment:

  • Scientific: Variability in clinical samples → increase cohort size and perform multi-site testing.
  • Regulatory: Delays in CE marking → start documentation early and maintain close communication with authorities.
  • Financial: Limited testing volumes → secure support from NGOs or insurers to ensure sufficient study participation.
  • Operational: Logistical or training challenges → implement standardized digital training modules and study protocols.

3. Online Direct-to-Consumer (B2C) Launch

Goal: Launch online sales following successful clinical validation, providing a discreet and accessible testing option for end users.

Activities

Risk Assesment

  • Scientific: User handling issues → optimize instructions and include visual/digital guides.
  • Regulatory: CE marking delays → initiate approval early and maintain proactive communication.
  • Financial: Slow initial uptake → leverage NGO collaborations and targeted digital campaigns.
  • Operational: Shipping or packaging bottlenecks → secure reliable logistics and fulfillment partners.

4. Retail & Pharmacy Expansion

Goal: Broaden availability through pharmacies, healthcare retailers, and selected grocery chains to make STI testing part of everyday healthcare.

Activities

  • Establish partnerships with pharmacies and retail chains for B2B distribution.
  • Introduce vending machine sales in selected locations to enhance accessibility.
  • Align marketing efforts with public health campaigns to encourage preventive screening.

Risk Assessment

  • Scientific: Shelf-life issues → refine formulation for long-term stability.
  • Regulatory: Retail compliance requirements → prepare documentation and engage early with regulators.
  • Financial: High marketing and logistics costs → roll out in phases to manage spending.
  • Operational: Distribution complexity → standardize processes and ensure clear partner coordination.

5. International Expansion & At-Home Testing

Goal: Expand to European and international markets and introduce enhanced at-home testing versions as regulations evolve.

Activities

  • Adapt regulatory submissions for EU and other markets.
  • Localize packaging, language, and digital platforms.
  • Build new partnerships with NGOs and public health agencies for awareness and adoption.

Risk Assessment

  • Scientific: Performance variations under different conditions → validate across multiple environments.
  • Regulatory: Country-specific delays → pursue parallel submissions.
  • Financial: Currency and logistics risks → mitigate via localized pricing and phased entry.
  • Operational: Localization challenges → engage regional distribution partners.

Product Line Expansion

While the MVP focuses on Syphilis, our core technology is pathogen-flexible, enabling expansion to other STIs such as Chlamydia, Gonorrhea, HPV, and Trichomonas vaginalis. Beyond STIs, the platform offers broader application potential that can be developed over time, allowing us to address a wide range of infectious diseases. This modular design enables portfolio expansion without reinventing the underlying technology, supporting rapid adaptation to new markets and emerging health needs.

Sales & Marketing Strategy

Our approach to marketing focuses on ensuring the test is widely adopted and promoting consistent testing behavior. We based our strategy on the insights gained from our conversation with Dr. Walter Bierbauer, a health psychologist from the University of Zurich.

Messaging

Our aim is to promote testing as a regular health monitoring routine for sexually active individuals, rather than a fear-induced task. We will advertise our test as a screening tool rather than a diagnostic tool, to avoid encouraging risky customer behavior and driving away customers sensitive to stigma. We will encourage users to incorporate testing into their health routine (like tooth brushing, fitness, or regular checkups).

To achieve this, education is central. Partnerships with NGOs, clinics, sexual health campaigns, governmental organizations, and insurance companies will spread public risk awareness and support the importance of testing. Active and extensive social media work, as already implemented on our current Instagram account, will help increase reach and engagement. Targeted information will be provided to high-risk individuals, as well as to institutions and organizations with high levels of infection spread, such as retirement homes and festivals.

Trust

Our survey showed that many potential customers fear self-tests lack result accuracy compared to regular laboratory tests. It will therefore be important to be transparent about the quality of our test and indicate certifications on promotional materials, websites, and packaging. A 1-year pilot study will be conducted in collaboration with clinics to showcase and improve our test’s performance. Our branding will emphasize a professional, medical appearance rather than flashy marketing.

Privacy concerns will be addressed by highlighting discretion and anonymity in online and physical marketing materials. We will work with our shipping company to ensure discreet shipment and packaging.

Agarose Gel
Figure 2: Number of Participants in our survey agreeing that these Reasons make them feel uncomfortable about using an STI Self-Test

Instructions and Digital Support

To increase the usability of our product, we aim to make its handling as easy as possible. Instructions in multiple languages will be included in the packaging and available online on a dedicated webpage, as well as additional visual aids, such as pictures and videos. The language will be kept simple, making the content easy to understand and approachable. Our Product page illustrates how such a potential website informs customers on the use and offers guidance on the steps to be taken after a diagnosis, reducing uncertainty and fear. Future app development will further facilitate reminders promoting regular testing and personal risk assessment.

Direct-to-Customer Distribution

The validated product will first be available online via our own website as well as on e-commerce platforms for direct-to-customer sales in order to gain quick market access. Our survey confirmed online platforms as a desired point of sale for our potential customers. Tests will be available as single-test purchases as well as subscription models. The tiered subscriptions offer tests sent at regular time intervals, targeting high-risk customers.

We will then further extend distribution to physical retail, starting with pharmacies before expanding to convenience stores and retail markets. Our survey indicated that pharmacies are an important point of sale.

Agarose Gel
Figure 3: Preferred Ways of the Participants of Our Survey to Access STI Tests, 803 Responses in Total, 301 Participants.

B2B and Partnerships

Larger package deals and long-term contracts will be offered to organizations. Institutions such as schools or retirement homes and corporate wellness programs may use our product to promote regular testing. Event organizers such as festivals might provide testing as part of health and safety measures.

Collaborations with NGOs, sexual health campaigns, governmental organizations, and insurance companies will promote public acknowledgment and trust in the product while spreading risk awareness and underlining the importance of testing. These partnerships will be motivated by the common interest in reducing the spread of STIs.

Financial Plan

Our financial plan follows a logical and transparent trajectory from product development through validation to full commercialization. It has been designed to reflect realistic financial behavior for a young biotechnology venture, balancing scientific requirements with operational sustainability. To support this strategy, we plan to incorporate the company as a Swiss public limited company (AG). This legal form is well suited for biotechnology ventures, as it facilitates equity-based financing, provides a clear governance structure, and allows for scalable growth.

From the project start (November 2026) until March 2026, our activities are entirely focused on research, product optimization, and preparation for regulatory approval. During this period, we will not generate any revenue, as all efforts are devoted to developing the test, ensuring compliance with medical standards, and setting up efficient production workflows. Between April 2026 and March 2027, we will conduct our pilot clinical study, which serves as the validation phase necessary to obtain regulatory clearance [15]. This entire period is also non-revenue-generating. To minimize costs in these early stages, no team member will receive a salary until October 2026 [16], and all nine team members are working part-time at 35 % employment. Starting in October 2026, each team member will receive an annual salary of 21,000 USD (equivalent to approximately 1,750 USD per month, excluding the 12 % social contribution supplement, which brings the total to about 23,520 USD per year or 1,960 USD per month), based on a full-time equivalent of 60,000 USD per year.

At the same time, from October 2026 onward, we will also start paying for office space and related overhead, estimated at 1,000 USD per month. This increases our fixed costs slightly, but remains manageable and reflects the transition from a purely research-based setup to a small operating company.

After one year of operations, once the company structure and accounting processes are established, we will hire an accountant or financial officer, also at 35 % employment, with the same annual cost of 23,520 USD, including the 12 % social contribution supplement. This role is essential for managing financial reporting, investor relations, and future regulatory documentation. These personnel costs, together with regulatory, marketing, and office expenses, form the base of our fixed monthly costs shown in the “Fixed Costs” sheet.

Our pricing structure differentiates between two key markets. The business-to-consumer (B2C) price per test is set at 25 USD, while the business-to-business (B2B) price is 15 USD per test. The cost of goods sold (COGS) is estimated at 4 USD per unit, including materials, assembly, and distribution costs. These figures yield gross margins of 21 USD per B2C test and 11 USD per B2B test, which provide sufficient contribution to cover fixed costs and generate profit as sales grow. According to our survey data, 60-95.5% of people interviewed are willing to pay 25 USD for such a test, supporting our proposed pricing model.

Agarose Gel
Figure 4: Highest Price Range Participants of our survey would be willing to pay for an STI Self-Test.

Because our product targets a sensitive health area, we assume that online direct-to-consumer sales will be our main sales channel [17], especially in the early market phase. Therefore, we decided to launch our product online first. Many users prefer the privacy and discretion of ordering online rather than purchasing through clinics or pharmacies. This behavioral pattern has been confirmed in comparable diagnostic markets and is reflected in our “Units by Channel” and “Revenue Model” sheets. Institutional (B2B) sales will develop more slowly but will gain importance once the brand and clinical validation are fully established.

To finance the pre-commercial period, we will receive 300,000 USD from a single private investor in exchange for 20 % equity in the company. In addition to this ownership share, the investor will receive 10 % of the annual net profit after taxes, starting once the company becomes profitable. This single-investor model simplifies governance and ensures that financial incentives remain aligned. The investment covers all expenses from development through the clinical phase and up to the first months of commercialization in 2027.

The company will not generate any sales revenue before April 2027, as we are focused exclusively on achieving regulatory approval. Sales begin immediately after launch, with online B2C channels leading initial adoption. During this time, revenues increase rapidly, while fixed costs remain stable aside from the modest personnel and office expenses introduced in late 2026.

Our financial timeline can be summarized as follows:

Phase Start End Key Activity
Development & Setup pre-2026 March 2026 Build lab, establish manufacturing, regulatory preparation
Pilot / Clinical Study April 2026 March 2027 Conduct validation study and gather clinical data
Commercial Launch April & July 2027 onward Begin B2C (April) and B2B (July) sales
Growth Phase 2028 onward Scale sales, expand marketing and distribution
Break-even April 2028 Total revenue surpasses cumulative costs
Table 5: General overview and timeline of the financial plan.

This timeline demonstrates a clear logic: first, a development phase with no revenue and minimal costs; then, a validation phase that establishes trust and regulatory compliance; followed by immediate sales growth after launch; and finally, profitability reached within one year of commercialization.

Based on the “Annual Summary” and “Break-even Analysis” sheets in our financial model, the projected break-even year is 2028, when cumulative revenues are expected to exceed total accumulated costs.

Agarose Gel
Figure 5: Annual Summary graph showing revenue, total cost, and the break-even point in 2028.

The “Break-Even Chart” visually represents this point: the revenue curve begins to rise sharply after 2028, intersecting the comparatively stable total cost line. This marks the company’s transition to profitability, after which each additional sale generates positive net profit and cash flow.

Our growth rate assumptions are based on empirical adoption patterns of diagnostic and biotechnology products [18, 19]. For the first two years after launch (April & July 2027 - March 2029), we project monthly growth rates of 12 % for online B2C, 5 % for B2B clinic, 12 % for B2B retail, and 8 % for B2B vending machine sales. When compounded, these correspond to approximately annual growth rates of 290 % (online B2C and retail), 80 % (B2B clinic), and 150 % (vending machines).

From April 2029 onward, as market penetration increases and early adoption slows, these rates are halved to 6 %, 2.5 %, 6 %, and 4 % per month, respectively - or roughly 130 %, 35 %, 130 %, and 60 % annually. This transition reflects the typical evolution from rapid initial uptake to more moderate, sustained growth once a product is established. Such patterns are consistent with industry evidence. Analyses like “Understanding Diagnostic Adoption Curves: How Evidence, Incentives, and Precedent Shape Uptake” (DeciBio Consulting, 2024) [18] show that diagnostic innovations experience steep early growth followed by gradual stabilization as awareness matures and competition emerges. Our assumptions follow this empirically supported trend while remaining deliberately conservative.

Taxation is modeled at a 30 % corporate rate, used as a conservative blended assumption to account for potential international sales exposure and future regulatory changes [20]. While effective Swiss rates are typically lower, this buffer ensures that our post-tax profit projections remain realistic and sustainable. After deducting taxes and the 10 % investor profit share, the remaining profits are not yet allocated to reinvestment in the current financial plan. This is a deliberate choice to keep the early-stage model transparent and focused on core financial performance. However, our long-term strategy clearly foresees reinvesting future profits into research, marketing, and company growth once positive Cashflow is achieved.

Altogether, our financial plan presents a consistent and data-driven scenario that connects every operational assumption to a quantifiable outcome. The early decision not to pay salaries until October 2026 [16] allows us to conserve capital during the non-revenue phase. The 35 % employment model for all team members ensures that we can maintain a skilled, motivated workforce while keeping total payroll costs efficient. The modest fixed costs for office, marketing, and regulatory maintenance reflect prudent financial management. The 300,000 USD investment provides sufficient funding to reach commercialization, while the clear structure of 20 % equity and 10 % profit participation maintains investor confidence without over-diluting ownership.

By April 2028, the company becomes financially self-sustaining, with revenues exceeding expenses and a growing profit margin. The plan is transparent, realistic, and aligned with industry benchmarks. Supported by the detailed “Annual Summary” sheet data, as well as the accompanying financial chart, it provides a complete picture of how our project evolves from research and validation to a profitable and scalable diagnostic enterprise.

The financial model was reviewed by Linard Pitsch (Finance & Controlling Expert, formerly EMS-CHEMIE AG, stakeholder engagement page will follow). His feedback helped ensure that our assumptions and structure reflect best practices for early-stage biotechnology ventures.

Overview of our 5-Year Financial Plan:

PDF Excel sheet Financial Plan

Overview of our 21-Month Project Execution Plan:

PDF Gantt Chart 21 Month

Our Supporters

We have established contact with a startup incubator program, with our first meeting planned shortly after the wiki freeze.

Who We Are

A startup requires diverse expertise. To begin with, we have outlined the key tasks ahead and how we plan to approach them. Our team consists of motivated students in biomedicine and biology, representing different countries and perspectives. While we bring strong scientific skills and creativity, we are aware of the areas where we will need external support.

Through our iGEM experience, the wet-lab team can perform the laboratory work required to establish the testing method and prepare it for product integration. For certain steps, we will seek expert input through interviews and paid consulting. The transition from a working lab prototype to a scalable, market-ready product will require collaboration with contract manufacturers for enclosure, assembly, and packaging.

Regulatory compliance and intellectual property will be outsourced to specialized experts. Likewise, financial management will evolve from our iGEM budgeting experience to professional oversight once initial sponsorship and funding are secured.

Website development and online sales will be handled by our wiki team, while marketing will initially rely on our internal creative team before expanding in collaboration with business professionals.

In summary, our main needs lie in legal/regulatory and financial/business areas.

References

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