Diagnostic tests for Lyme disease may soon get a major upgrade, as seven innovative research and development teams ready their novel methods for review by the Food & Drug Administration.
If the FDA deems them market-ready, these new tests could dramatically improve physicians’ abilities to detect early-stage, as well as latent and chronic Borrelia burgdorferi infections, along with other related tick-borne pathogens.
The new crop of tests are the first fruits to emerge from the LymeX Innovation Accelerator—the largest Lyme-focused public-private endeavor of its kind–has earmarked over $10 million in cash prizes for R&D teams in biotech and/or academia, that are able to bring forward clinically-validated, FDA-approvable testing methods.
First established in 2020 during the first Trump term, the LymeX Accelerator is a collaboration between the US Department of Health & Human Services, and biotech and academic research teams. Modelled on HHS’ successful KidneyX accelerator, the it’s a private-public “moonshot” aimed at developing new and better diagnostics and treatments for Lyme and other tick-borne disorders.
Funding for the cash awards comes from the Steven & Alexandra Cohen Foundation, a broad-ranging philanthropy, and the biggest private funder of research on Lyme and tickborne diseases. Steven Cohen—a hedge fund manager with a personal net worth upwards of $21 billion—and his wife Alex started LymeX after their own years-long ordeals with Lyme.
HHS’s monetary investment in the LymeX Accelerator is minimal—a nominal $5 million in logistics and implementation support–and there are no specific federal appropriations on the horizon. But the administration has committed various departments under its aegis to provide the Accelerator with AI screening tools, data-sharing capabilities, and public education platforms.
Renewal of the LymeX partnership is a cornerstone in HHS’s new initiative to combat chronic Lyme disease, detailed in an hours-long roundtable last December. The administration has made it a priority to address the major gaps in diagnostic testing, the spotty clinical care many Lyme patients receive, and the general dismissal of the reality of chronic Lyme that has characterized federal policy—as well as insurance reimbursement guidelines—for decades.
At the crux of the problem is the fact that conventional serologic testing often misses early-stage infections, because it can take up to 4 weeks for the immune system to develop antibodies to Borrelia burgdorferi. Though it is accurate in detecting later stages of infection, standard two-tiered antibody testing cannot accurately distinguish between currently active versus past inactive infections, and it becomes much less accurate over time, as the pathogen sequesters itself in the body’s collagen-rich tissues.
Conventional logic dictates: “No bug, no disease, and no need for treatment.” After decades of wanton antibiotic overuse, some degree of discretion is totally reasonable. But because of the limitations of current testing methods, many who do need treatment are not getting it.
And unless a physician thinks to order a PCR-based test to identify B. burgdorferi in synovial fluid, or tests for other arthropod-borne pathogens like Borrelia, Bartonella, Anaplasma, and Babesia, these problems usually go undetected, though they can cause significant dysfunction in multiple organ systems.
Consequently, patients who have longstanding complex symptoms that emerged or persisted months or even years after a tick bite, are told they don’t have Lyme, or if they did, the infection has resolved. They don’t get treated, and they don’t get better.
The seven 7 R&D teams close to the FDA finish line with new tests are advancing novel blood and urine methods for detecting B. burgdorferi across all stages of infection, including latent and chronic phases.
BlueArc Biosciences Inc: This biotech startup has developed an ultrasensitive blood test for direct detection of B. burgdorferi at the very onset of symptoms, thus eliminating the typical 2-4-week seroconversion period between initial infection and development of antibodies detectable with standard methods. BlueArc’s method utilizes standard lab equipment, but targets previously unrecognized markers that directly detect the presence of the spirochete, rather than waiting for the immune system’s response to it.
Drexel University College of Medicine: A Drexel team led by Mary Anne Communale has created a new small-volume serum assay that uses glycan biomarkers to detect active B. burgdorferi infections. The test may help in early detection as well as treatment monitoring.
HelixBind Inc: This Boston-area biotech company has developed an entirely new technology platform for detecting Borrelia DNA directly from human blood. HelixBind’s tests make use of RaPID/LD for rapid amplification of genetic material. This technology has been successfully applied to detection of tuberculosis, respiratory syncytial virus, and other respiratory infections. It can return highly sensitive results, often within 15-30 minutes.
Galaxy Diagnostics: Based in North Carolina’s Research Triangle Park, Galaxy is focused on highly-sensitive urine antigen tests to detect Borrelia, as well as Bartonella, and Babesia–the tick-borne “stealth pathogens” that easily evade standard serum antigen tests. Galaxy’s tests detect the pathogens themselves, not the body’s immune response to them.
Northwestern University Feinberg School of Medicine: A Northwestern reserch team headed by Brandon Jutras, PhD, has combined monoclonal antibody testing with immuno-PCR based methods that can quickly detect the presence of a specific Borrelia peptidoglycan in both blood and urine. This peptidoglycan, which appears to be a strong driver of chronic inflammation, can also be found in synovial fluid long after the initial phase of infection.
Massachusetts General Hospital: Mass General has long been at the forefront of Lyme research. In fact, Allen Steere, who currently heads the hospital’s Lyme arthritis program, is credited with discovering and characterizing Lyme Disease back in 1976. Today, Mass General researchers John Branda and Jacob Lemieux, have applied whole genome sequencing techniques to identify low levels of Borrelia nucleic acid chains in blood. Their method attenuates human background material from the serum samples, strengthening the genetic signals indicating the pathogen’s presence.
GNOMX Corp: New York City based GNOMX brings AI to bear in the assessment of epigenetic signals suggestive of B. burgdorferi infection. Though it is an indirect method, in that it does not directly detect the pathogen, it utilizes biologically distinct indicators, and has proven to be highly sensitive in early trials, with a greater than 90% accuracy in detecting early-stage Lyme.
It remains to be seen which of these new methods will win nods from FDA. But the growing surge of research in the Lyme disease field is surely a good sign that the stasis that has characterized clinical detection and treatment of Lyme is in for a shake-up in the near future.
END
