On July 13, 2022, Dr. John Aucott and Dr. Liz Horn joined the LymeX team to discuss the fundamentals of Lyme disease detection and considerations for development and evaluation of diagnostics. The presentation highlighted key considerations for entrants as they prepare their concept papers and develop innovative methods for detecting active Lyme disease infections.
Following the presentation, the speakers answered questions from attendees — see a summary in the updated competition FAQ.
One of the key barriers to developing new diagnostic tests is the unusualness of Borrelia burgdorferi, the Lyme disease-causing spirochetes. The genome of the obligate parasite has been described as one of the most complex of all bacteria. Difficult to culture, reproductions are only available in a small number of research labs.
“It’s a very motile, fast-moving spiral bacteria that’s distantly related to gram-positive and negative bacteria. It has a funny genome, a linear chromosome, but also linear and circular plasmids that comprise the genome. Its long slender morphology makes it very difficult to see by standard light microscopy… Everything about Borrelia burgdorferi is unique.”
— Dr. John Aucott, Director, Johns Hopkins Lyme Disease Clinical Research Center
There’s a high-potential market for a direct diagnostic test: An estimated 476,000 Americans are diagnosed and treated for Lyme disease each year — but the true number of infections is unknown, largely due to issues with existing testing. Understanding the limits of today’s Lyme disease tests is critical to accelerating diagnostic innovation.
“Here are some limitations of current testing types: Serology isn’t sensitive in early disease. The results are really influenced by antigens in the first tier. We’ve run multiple first-tier ELISAs and we get different results in some patients. There’s cross-reactivity with non-Borrelia antibodies with look-alike diseases. If you obtain the CDC panels, they have a number of diseases where there can be cross-reactivity. It doesn’t differentiate from current or previous infection. People that live in endemic areas and may work outside can get Lyme disease multiple times.”
— Dr. Liz Horn, Principal Investigator, Lyme Disease Biobank
The first phase of the competition calls on all eligible entrants — including scientific, technical, and clinical experts — to submit detailed concepts and plans for development by 4:59 p.m. ET on August 8, 2022. Each entrant will submit a concept paper that describes their proposed solution, how it will diagnose an active infection of Lyme disease, benefits to patients and clinicians, and a scientifically rigorous rationale for success.
Submissions should include an ambitious but achievable roadmap for prototyping, iterating, testing/validating, and evaluating the proposed test(s). Entrants should also indicate their anticipated pathway toward eventual FDA review and clearance. Up to 10 Phase 1 winners will receive an equal share of the $1 million Phase 1 prize pool. If the planned Phase 2 moves forward, the winners of Phase 1 will be exclusively invited to participate in the second phase (Phase 2) of the competition.
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