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 system—originally developed in 1994 for disease surveillance, not as a stand-alone diagnostic test—relies 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.

Meet the teams

Here are the teams participating in Phase 3:

• BlueArc Biosciences Inc. (La Jolla, California). A molecular diagnostic blood test for B. burgdorferi s.l. using an innovative polymerase chain reaction (PCR) assay and standard laboratory equipment to target biomarkers.
• Drexel University College of Medicine (Philadelphia). A small-volume serum test using glycan biomarkers to detect active Lyme disease infection and track treatment response.
• HelixBind Inc. (Boxborough, Massachusetts). An ultrasensitive, automated test detecting and identifying active B. burgdorferi directly from blood in three hours.
• Massachusetts General Hospital (Boston). A plasma test depleting human background material from samples and detecting low-abundance nucleic acid from tick-borne pathogens.
• Northwestern University, Feinberg School of Medicine (led by Jutras Lab, formerly at Virginia Tech.) (Chicago). A test using monoclonal antibodies in conjunction with both immuno-PCR and lateral flow to rapidly detect a unique B. burgdorferi biomarker in blood and urine.
• Tufts University (Boston). A serum test targeting a unique antibody that would accurately identify early infection and allow clinicians to optimize additional treatment.

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.

Cohort to present diagnostic tests at Demo Day

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.

Phase 3 to award up to $2.1 million in prizes

The competition judging panel—composed of experts across sectors such as biology, clinical and technology translation, patient experience and advocacy, diagnostic science and technology, innovation, and ethics—will 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.

Phase 4 to advance diagnostics toward FDA review 

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