As part of the Phase 2 virtual accelerator, the LymeX Diagnostics Prize hosted a webinar on stakeholder-centered design for diagnostic tests. The ultimate goal of the multiphase competition is to nurture the development of these diagnostics toward Food and Drug Administration (FDA) review.

Drawing upon his deep experience in medical device product development, Dr. Andrew DiMeo presented to the accelerator cohort on the principles of stakeholder-centered design and the importance of engaging with diagnostic test users to understand their needs. He demonstrated how teams can use levels of abstraction, a design tool that identifies user needs and leads to informed solutions. Later, he highlighted how stakeholder-centered design informs the development of the design history file, which is a key element of an FDA application. Following the presentation, Dr. DiMeo led the teams in a live Q&A.

For additional information, patients, clinicians, and innovators can explore the following resources:

Learn more about Dr. Andrew DiMeo.

A look at the Phase 2 accelerator

In January 2023, the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation invited the 10 Phase 1 winners to participate in the Phase 2 virtual accelerator. The nine month accelerator offers the cohort access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the teams progress toward FDA review.

By using a prize competition, rather than relying on traditional grantmaking, the LymeX Diagnostics Prize offers cash prizes alongside a range of non-monetary resources. Following the accelerator, the cohort will submit concept papers that detail solution refinement, clinical and patient input, and a roadmap from lab to market.

The competition judging panel—composed of experts in areas such as vector-borne disease biology, clinical and technology translation, patient experience and advocacy, and diagnostic science and technology—will evaluate eligible submissions according to official Phase 2 evaluation criteria. Based on the judges’ evaluations, the judging panel will recommend up to five Phase 2 winners of the LymeX Diagnostics Prize, with at least $250,000 per winner.

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