New Lyme diagnoses are on the near horizon

Diagnostic tests for Lyme disease may soon get a big upgrade, as seven innovative research and development teams prepare their new methods for review by the Food and Drug Administration.

If deemed market-ready by the FDA, these new tests could significantly improve doctors’ ability to detect early-stage, as well as underlying and chronic diseases. Borrelia burgdorferi Infections, along with other tick-borne pathogens.

The new crop of tests is the first fruits to appear from LymeX Innovation Accelerator— the largest public-private endeavor of its kind focused on Lyme — has allocated more than $10 million in cash awards to R&D teams in biotechnology and/or academia that are able to deliver clinically validated, FDA-approved testing methods.

First created in 2020 during Trump’s first term, the LymeX Accelerator is a collaboration between the U.S. Department of Health and Human Services and academic research and biotechnology teams. Similar to the success of HHS KidneyX acceleratorIt is a public-private initiative aimed at developing new and better diagnostics and treatments for Lyme disease and other tick-borne disorders.

Funding for cash prizes comes from Stephen and Alexandra Cohen Foundationa large-scale charitable foundation, is the largest private funder of research into Lyme and tick-borne diseases. Steven Cohen — a hedge fund manager with a personal net worth of more than $21 billion — and his wife, Alex, founded LymeX after their years-long ordeal with Lyme.

The Department of Health and Human Services’ cash investment in the LymeX Accelerator is minimal — a nominal $5 million in logistics and implementation support — and there are no specific federal allocations on the horizon. But the administration obligated the various departments under its auspices to provide the accelerator with artificial intelligence screening tools, data exchange capabilities, and public education platforms.

The renewal of the LymeX partnership is the cornerstone of… New HHS Initiative to Combat Chronic Lyme Diseasein detail in an hours-long roundtable last December. The administration has made it a priority to address major gaps in diagnostic testing, the interrupted clinical care that many Lyme patients receive, and a general rejection of the reality of chronic Lyme disease that has characterized federal policy — as well as insurance reimbursement guidelines — for decades.

The crux of the problem lies in the fact that conventional serological tests often fail to diagnose infections in the early stages, because it can take up to 4 weeks for the immune system to develop antibodies against the infection. Borrelia burgdorferi. Although accurate at detecting later stages of infection, the standard two-tier antibody test cannot accurately distinguish between currently active infections versus previous inactive infections, and becomes much less accurate over time. It also isolates pathogens themselves In body tissues rich in collagen.

Conventional logic dictates: “There is no defect, no disease, and no need for treatment.” After decades of antibiotic overuse, some degree of discretion is quite reasonable. But because of limitations in current testing methods, many people who need treatment don’t get it.

Unless the doctor thinks about ordering a PCR test to identify it
for. burgdorferi In synovial fluid, or testing for other arthropod-borne pathogens such as Borrelia, Bartonella, Anaplasma, and Babesia, these problems usually go undetected, although they can cause significant dysfunction in multiple organ systems.

Thus, patients with complex, long-term symptoms that appear or persist months or even years after a tick bite are told that they do not have Lyme disease, or if they do, that the infection has resolved. They are not treated, and they do not get better.

The seven R&D teams that are nearing the FDA finish line with new tests are developing new ways to detect blood and urine for. burgdorferi At all stages of infection, including latent and chronic stages.

Blue Arc Biosciences Company: This biotech startup has developed an ultra-sensitive blood test for direct detection of… for. burgdorferi at the onset of symptoms, thus eliminating the typical seroconversion period of 2 to 4 weeks between primary infection and the development of antibodies detectable by standard methods. The BlueArc method uses standard laboratory equipment, but targets previously unrecognized markers that directly detect the presence of spirochete, rather than waiting for the immune system to respond to it.

Drexel University College of Medicine: The Drexel team led by Mary Anne Communale has created a new, small-scale serum test that uses glycan biomarkers to detect active B. burgdorferi infection. Testing may help in early detection as well as monitoring treatment.

Helix Bend Company: A Boston-area biotechnology company has developed an entirely new technology platform to detect Borrelia DNA directly from human blood. HelixBind tests use RaPID/LD technology to rapidly amplify genetic material. This technology has been successfully applied to detect tuberculosis, respiratory syncytial virus, and other respiratory infections. It can produce very sensitive results, often within 15-30 minutes.

Galaxy diagnosis: Galaxy, based at North Carolina’s Triangle Research Park, is focusing on highly sensitive urine antigen tests to detect Borrelia, as well as Bartonella and Babesia — tick-borne “stealth pathogens” that easily evade standard serum antigen tests. Galaxy tests detect the pathogens themselves, not the body’s immune response to them.

Northwestern University Feinberg School of Medicine: A Northwestern University research team led by Brandon Jutras, Ph.D., has combined monoclonal antibody testing with immuno-PCR-based methods that can rapidly detect the presence of specific Borrelia peptidoglycans in both blood and urine. This peptidoglycan, which appears to be a powerful 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 Steer, who currently heads the hospital’s Lyme arthritis program, is credited with discovering and characterizing Lyme disease in 1976. Today, Mass General researchers John Branda and Jacob Lemieux have applied whole genome sequencing techniques to identify low levels of Borrelia DNA sequences in the blood. Their method dilutes human substrates from serum samples, enhancing genetic signals that indicate the presence of the pathogen.

1. Company: New York City-based GNOMX uses artificial intelligence to evaluate epigenetic signals that suggest for. burgdorferi infection. Although it is an indirect method, in that it does not directly detect the pathogen, it uses distinct biomarkers, and has proven to be very sensitive in early trials, with over 90% accuracy in detecting Lyme disease at an early stage.

It remains to be seen which of these new methods will receive FDA approval. But the increasing increase in research in the field of Lyme disease is certainly a good sign that the stagnation that has characterized the clinical detection and treatment of Lyme disease will see a radical change in the near future.

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