The LymeX Diagnostics Prize has officially launched Phase 4, marking a major step forward in the effort to develop improved diagnostics for Lyme disease. Seven cutting-edge teams are now advancing their clinical validation plans, working toward FDA submission.
Among them is the Jutras Lab, now at Northwestern University Feinberg School of Medicine, led by Global Lyme Alliance grantee, Brandon Jutras, Ph.D. Their innovative test leverages monoclonal antibodies with immuno-PCR and lateral flow technology to rapidly detect a unique Lyme disease biomarker in blood and urine.
What’s Next
- Teams will execute clinical validation studies and refine their diagnostics. This means the teams will test their diagnostics using real patient samples to make sure they work accurately and reliably. If needed, they’ll make improvements to ensure the tests give fast, correct results, while working with doctors, laboratories, and regulatory experts to meet FDA requirements.
- To qualify for $200,000 milestone prizes, teams must submit a regulatory package to the FDA that is accepted for substantive review. This means the FDA isn’t just acknowledging receipt of the application, they will be actively evaluating the data to decide if the test can move forward toward potential approval.
- An additional $3 million in FDA clearance prizes will be available for teams whose tests receive FDA authorization, with the first to secure clearance taking the top prize.
With funding, expert mentorship, and technical resources, Dr. Brandon Jutras and his team are advancing Lyme diagnostics toward real-world impact. We are proud to support his research and look forward to seeing the progress from all the teams involved.
See the announcement here 7 teams advance to Phase 4 - LymeX Diagnostic Prize
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