The LymeX Diagnostics Prize has announced the Phase 3 winners in the $10+ million competition to accelerate the development of Lyme disease diagnostics.

Through Phase 3, the teams had access to webinar modules, mentorship, and networking opportunities as they planned clinical performance studies to validate their proposed solutions.

The goal of this multiphase LymeX Innovation Accelerator (LymeX) competition is to nurture the development of diagnostics toward Food and Drug Administration (FDA) review and clearance. The LymeX Diagnostics Prize is made possible thanks to a more than $10 million pledge from the Steven & Alexandra Cohen Foundation.

Meet the winners in the $2.1 million Phase 3

From May to October 2024, the teams met with subject matter experts who offered guidance on clinical study design, regulatory engagement, biostatistics, and product development.

Industry supporters Labcorp and Quest Diagnostics provided non-financial in-kind support, helping teams deepen their understanding of the diagnostics industry, how clinical laboratories operate, and how to work with commercial laboratories.

Teams also had the opportunity to visit Labcorp’s and Quest Diagnostics’ clinical reference laboratory facilities to learn more about these environments and their workflows, materials, and instrumentation.

Learn more about the Phase 3 winners, who will each be awarded $420,000:

• BlueArc Biosciences Inc. (La Jolla, California). An ultrasensitive and specific blood test for the direct detection of B. burgdorferi infection from the first symptoms of Lyme disease using standard laboratory equipment.
• 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. (Marlborough, Massachusetts). A direct-from-blood molecular assay that can detect DNA from intact Borrelia spirochetes utilizing a proprietary, readily automated sample-to-answer process.
• Massachusetts General Hospital (Boston). A plasma and extracellular fluid 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.

The competition judging panel — composed of experts in clinical practice, patient experience, diagnostic development and validation, regulatory review and compliance, vector-borne disease research, and commercialization — evaluated eligible submissions according to official Phase 3 evaluation criteria.

Each team submitted a concept paper that detailed how they have engaged the FDA and implemented feedback received, as well as new or improved analytical performance data, current clinical performance study protocol, and progress it has achieved in planning and initiating its clinical performance study.

Phase 4 to support clinical validation studies

Phase 4 will invite select teams to enter, execute their 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.

The competition administrator reserves the right to invite individuals, teams, or entities to compete in Phase 4; these invited teams may or may not have competed in previous phases. Invited teams will be required to demonstrate commitment to achieving the objective of Phase 4 of the LymeX Diagnostics Prize.

SOURCE: LymeX Diagnostics Prize