US-based Find Out From Home LLC ("FindOut"), formerly known as MyMark and Devyn, is a US-based biotech company focused on providing accessible, user-friendly at-home diagnostic testing, empowering people to manage their health proactively through easy-to-use at-home health tests.
In 2022, FOFH awarded Abingdon Health the contract for developing a range of lateral flow tests for sexually transmitted infections ("STIs"), from proof of concept through to routine manufacture. Later, in late 2024, FOFH also contracted Abingdon Health for comprehensive regulatory support services. This included performance evaluation and clinical testing of four STI tests, aiming for submission and approval by the US FDA, UKCA, and CE marking via IVDR.
Challenges
Given that sexually transmitted infections are a sensitive topic, development of these diagnostic self-tests presents several significant hurdles:
- High Accuracy, Fast Results: Achieve ≥ 98–99 % sensitivity & specificity while keeping the “20-minutes-toresult” promise.
- Intuitive Design for Privacy: Design a kit so intuitive even a 14-year-old can run it in total privacy, without mailing samples or deciphering faint lines.
- Global Regulatory Navigation: Prepare the clinical trials on different continents (USA & Europe), and make sure we can go through both pathways without any issues.
Solution
Abingdon Health isn’t just a vendor; they’re a strategic partner. Their offering extends beyond manufacturing capacity, with an amazing, highly-skilled R&D team capable of tackling diverse diagnostic challenges. This is complemented by 45 dedicated regulatory experts and manufacturing facilities in both Europe and the US.
This comprehensive "bench-to-approval" workflow enables FOFH to concentrate on critical business aspects like marketing, subscription models, and multi-channel distribution, while Abingdon Health manages the scientific development, quality assurance, and regulatory submissions.
Results & Impact
This collaborative approach has yielded significant progress. Four of the home use STI self-tests have successfully reached design freeze, with clinical trials scheduled to commence in July 2025. FindOut is on track for US FDA clearance and a US market launch in Q2 2026, with subsequent EU/UK launches anticipated in Q3. This rapid advancement demonstrates the efficacy of Abingdon Health's integrated approach.
"The commitment and hands-on responsiveness from Abingdon Health's leadership and entire team has been exceptional. It is a pleasure to partner with a team which understands our goals and works with us to achieve them. STI testing is a complicated topic, with many challenges, which are being overcome one by one as we move throughout the process."
Why did you choose Abingdon Health?
Since day one and our first discussion, we could see that Abingdon’s approach to rapid tests is different from their competitors. Their focus is on usability, accuracy, market success, strategy, which is what FindOut looks for in a partner. We are building with them, in collaboration, instead of just being another client.
