Teams are working to advance novel diagnostic solutions toward clinical validation and FDA submission.
Lyme disease remains the most common vector-borne illness in the United States, yet the diagnostic tools available to patients and clinicians have changed little in decades. Current approaches can result in incorrect or missed diagnoses, particularly early in the acute stage when available treatments are most effective. The LymeX Diagnostics Prize was launched to change that, accelerating the development of next-generation diagnostics that can detect active Lyme disease infection with greater speed and accuracy.
Nearly one year into Phase 4, the competition is supporting teams to execute their clinical validation plans and prepare regulatory submissions to the FDA. To support this ambitious work, the prize is providing teams with targeted technical assistance, direct engagement with subject matter experts, and networking opportunities with industry partners to support future commercialization. Through collaborations with industry supporters — the Clinical & Laboratory Standards Institute (CLSI), Labcorp, and Quest Diagnostics — the prize provides teams with non-financial in-kind support; this will help them navigate the complex diagnostics landscape and advance their solutions. Phase 4 will award up to $3 million in prizes, spanning milestone prizes and evaluation prizes.
Winter 2026 team updates
As Phase 4 teams make progress on their clinical performance studies and prepare to file regulatory submissions to the FDA, we invited each team to share a brief update on their current efforts.
The teams have worked hard to leverage the prize’s resources and support to reach the ambitious milestones. Notably, two Phase 4 teams announced a new partnership: Galaxy Diagnostics entered into a technology licensing agreement with Virginia Tech to bring Dr. Brandon Jutras’ solution into Galaxy Diagnostics’ portfolio. With this merger, there are now six teams competing for the $3 million in Phase 4 prizes. Read on for updates from each team.
BlueArc Biosciences Inc. (La Jolla, California).
BlueArc Biosciences has developed an ultrasensitive, qualitative molecular blood test for direct detection of early B. burgdorferi infection using standard diagnostic laboratory equipment. The assay is designed to identify infection during the acute phase — when first symptoms appear — and is particularly valuable for patients who test negative by current FDA-approved serological methods. Studies are ongoing to demonstrate improved sensitivity and specificity relative to the standard two-tier serological tests.
Drexel University College of Medicine (Philadelphia).
The GlycoLyme test has completed CDC premarketing evaluation and met equivalence requirements. A retrospective study is now underway using longitudinal samples collected over one year post-diagnosis to evaluate whether GlycoLyme can assess the risk of developing Post-Treatment Lyme Disease Syndrome (PTLDS). Early risk stratification could inform initial treatment decisions and support future research into PTLDS pathophysiology. The team also received a Notice of Allowance for the GlycoLyme patent in the United States.
HelixBind Inc. (Boxborough, Massachusetts).
HelixBind is conducting verification and validation of RaPID/LD, its proprietary direct-from-blood molecular assay for detecting Borrelia spirochetes associated with early Lyme disease, built on a workflow optimized for sensitivity in low single digit cells/mL range. Current activities include analytical and clinical performance evaluations and a prospective clinical study, alongside manufacturing scale-up, supply chain qualification, and quality system integration in support of regulatory submission and commercial launch.
Galaxy Diagnostics (Research Triangle Park, North Carolina).
Galaxy Diagnostics has entered a technology licensing agreement with Virginia Tech to integrate Dr. Brandon Jutras’ Borrelia peptidoglycan research into its diagnostic portfolio. The partnership unites Dr. Jutras’ proprietary antigen technology with Galaxy’s urine-based direct detection platform, enabling the detection of unique B. burgdorferi biomarkers in urine. Over the coming year, the teams will collaborate on clinical sample evaluation and scientific validation to support assay development and advance potential regulatory pathways.
Massachusetts General Hospital (Boston).
The MGH team is continuing to develop a plasma and extracellular fluid test that depletes human background material to enable sensitive detection of low-abundance nucleic acid from tick-borne pathogens.
GNOMX Corp (New York).
GNOMX is continuing to develop a high-sensitivity epigenetic blood test that detects host-response markers to identify active Lyme disease infection.
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