Galaxy Diagnostics and Virginia Tech Unite to Strengthen Direct Detection Approaches for Lyme Disease
By Nicole Danielle Bell, CEO of Galaxy Diagnostics and author of What Lurks in the Woods
The Diagnostic Uncertainty Clinicians Face
Clinicians evaluating patients with suspected tick-borne disease routinely manage diagnostic uncertainty. Prior exposure, immune variability, and timing-dependent antibody responses can complicate interpretation—particularly when test results do not align with a patient’s clinical presentation. These gaps are not theoretical; they affect real clinical decisions every day and highlight the need for diagnostic approaches that more directly reflect pathogen biology.
A Personal Catalyst for Change
I have seen these challenges not only as a clinician-facing problem, but as a personal one. My husband tested negative using the current standard-of-care Lyme serology, despite Lyme disease later being identified as a critical contributor to his illness. Like many patients and clinicians, we trusted the result. He ultimately passed away, leaving me to reflect on whether access to more reliable diagnostic tools earlier in his care pathway might have altered the outcome.
That experience reshaped my professional focus. It ultimately led me to Galaxy Diagnostics, a company focused on advancing tick-borne disease diagnostics beyond indirect immune signals and toward direct detection of pathogen-derived markers.
Moving Beyond Serology: Galaxy’s Direct Detection Strategy
Current Lyme diagnostics rely primarily on serology, which can be limited by delayed antibody development, prior exposure, and interpretive ambiguity. Galaxy’s approach instead targets pathogen-specific proteins shed by Borrelia and cleared into urine, enabling a noninvasive, direct testing strategy.
This diagnostic approach originated in discovery research at George Mason University, was first commercialized by Ceres Nanosciences, and has since been optimized at Galaxy for analytical and clinical performance. Its potential has been recognized nationally: Galaxy was selected as one of only seven teams to advance to Phase 4 of the LymeX diagnostic prize challenge.
LymeX—jointly funded by the Steven & Alexandra Cohen Foundation and the U.S. Department of Health and Human Services—was created to accelerate innovative Lyme diagnostics along a disciplined path toward FDA review and approval.
Collaboration Over Competition in the LymeX Ecosystem
LymeX brings together multiple teams pursuing distinct diagnostic strategies. From my decades of experience translating new technologies into clinical practice, I’ve learned one consistent lesson: meaningful progress rarely occurs in isolation. Complex diseases demand complementary approaches rather than siloed solutions.
From Galaxy’s perspective, the other LymeX teams were not competitors, but potential collaborators—and one approach, in particular, aligned closely with our scientific and clinical objectives.
A Complementary Target: Borrelia Peptidoglycan
Shortly after joining Galaxy, I asked Dr. Jennifer Miller, our Vice President of Clinical and Scientific Operations, which emerging diagnostic strategies she believed warranted close attention. She immediately pointed to the work of Dr. Brandon Jutras at Virginia Tech.
Dr. Jutras’s research identified peptidoglycan, a structural component of the Borrelia cell wall, as a novel and biologically informative diagnostic target. While peptidoglycan is common across bacteria, Borrelia’s peptidoglycan exhibits unique structural features. Importantly, his work demonstrated that Borrelia actively releases peptidoglycan fragments during growth and division.
From a clinical perspective, this work is particularly relevant because it links Borrelia biology directly to host immune activation. Peptidoglycan fragments are pro-inflammatory, biologically persistent, and capable of systemic circulation, offering insight into mechanisms that may contribute to ongoing inflammation even when traditional markers of infection are absent or ambiguous.
Based on their molecular size and chemistry, emerging evidence supports renal clearance and detectability in urine—making peptidoglycan a scientifically compelling complement to Galaxy’s existing urine-based antigen detection strategy.
December 2025: A Turning Point for Lyme Diagnostics
December 2025 marked an inflection point for Lyme diagnostics. Two developments, in particular, signaled a meaningful shift.
First, the U.S. Department of Health and Human Services convened a Lyme disease roundtable, publicly acknowledging the scale of unmet diagnostic need and the limitations of current tools. HHS reaffirmed its commitment to LymeX and indicated that additional federal initiatives would follow to support diagnostic innovation and responsible translation.
Second, Galaxy entered into an exclusive license agreement with Virginia Tech for Dr. Jutras’s peptidoglycan-based technology. Over the coming year, our teams will collaborate to collect and study clinical samples, evaluating complementary antigen targets across multiple stages of Lyme disease.
The goal is to advance this work toward FDA submission, while ensuring rigorous validation, reproducibility, and clinical relevance—ultimately enabling diagnostics that integrate more seamlessly into practice, through something as straightforward as a urine test.
A Convergence of Complementary Expertise
This partnership also represents a convergence of complementary expertise. Dr. Miller and Dr. Jutras first worked together more than two decades ago during their PhD training at the University of Kentucky, where both studied Borrelia biology. Their careers diverged but remained aligned in purpose.
Dr. Jutras advanced in academia, conducting world-class research at Yale University, and later leading research programs at Virginia Tech and now Northwestern University. Dr. Miller focused on translation—developing deep expertise in assay verification and validation at Galaxy and leading FDA-focused data collection efforts at a top contract research organization. Together, their combined experience spans discovery science, assay development, and regulatory execution.