Six teams advance to Phase 3 of LymeX Diagnostics Prize – LymeDisease.org

The Steven & Alexandra Cohen Foundation, led by philanthropist Alex Cohen, has launched Phase 3 of the LymeX Diagnostics Prize through a fiscal sponsorship with the Digital Harbor Foundation.

This phase invites six teams from Phase 2 to plan clinical performance studies for validating their proposed solutions.

Over the next four months, the Phase 3 teams will have access to webinar modules, mentorship, and networking opportunities. The goal of the multiphase competition is to nurture the development of diagnostics toward Food and Drug Administration (FDA) review.

With an estimated 476,000 cases in America annually, the U.S. has an urgent need for new Lyme disease diagnostics. The current two-tier antibody testing systemoriginally developed in 1994 for disease surveillance, not as a stand-alone diagnostic testrelies on the presence of antibodies and can only be used accurately four to six weeks after a patient becomes infected. Delayed diagnoses prevent timely and crucial treatment interventions.

Here are the teams participating in Phase 3:

From April through August, the cohort will have access to technical assistance on topics such as regulatory planning, clinical study design and implementation, clinician and patient considerations, manufacturing processes and quality management systems, and commercial development.

To support evaluation and encourage innovative approaches, the LymeX Diagnostics Prize will publish a target product profile for a diagnostic test during Phase 3.

In Fall 2024, the Phase 3 teams will present and publicize their diagnostic test at Demo Day, showcasing their proposed solutions to representatives from government and industry, including clinician and consumer organizations.

Following Demo Day, each team will submit a concept paper that details the FDA engagement undertaken and implementation of feedback received, new or improved analytical performance data, final clinical performance study protocol, and progress achieved in planning and initiating its clinical performance study.

The competition judging panelcomposed of experts across sectors such as biology, clinical and technology translation, patient experience and advocacy, diagnostic science and technology, innovation, and ethicswill evaluate eligible submissions according to official Phase 3 evaluation criteria. Based on this evaluation and judges recommendations, Phase 3 will award up to six prizes of $350,000 each.

The LymeX Diagnostics Prize is helping teams overcome diagnostic development barriers by providing funding and technical assistance while fostering cross-disciplinary collaboration and partnerships. Phase 4 will support teams as they execute clinical validation plans and complete regulatory submissions to the FDA, awarding up to $3 million in prizes. The competition anticipates awarding additional prizes for FDA clearance.

SOURCE: LymeX Diagnostics Prize

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Six teams advance to Phase 3 of LymeX Diagnostics Prize - LymeDisease.org