Direct-From-Blood Molecular Diagnostic Test to Rapidly Detect Early Lyme Disease

If left untreated, infection can spread to joints, the heart, and the nervous system. Millions of tests are performed for Lyme disease each year, including serology tests, polymerase chain reaction (PCR) techniques, Western Blot, and blood culture. These tests are labor-intensive, can take weeks to process, and are subject to high false-negative rates due to their inability to detect the presence of Borrelia. Because of these limitations, patients are frequently misdiagnosed or face a testing odyssey, taking years to reach a correct diagnosis. Now, a sensitive diagnostic test that identifies Borrelia burgdorferi directly from a patient’s blood could provide greater accuracy in the diagnosis of early Lyme disease, which may help improve care and lead to better patient outcomes.

Laboratory diagnosis of Lyme disease has traditionally used a two-tier process for detecting the presence of antibodies against Borrelia burgdorferi in a patient’s blood. Antibodies are proteins present in the blood when the body is responding to a specific infection. In the case of Lyme disease, antibodies can take several weeks to develop, so patients may test negative using current FDA-cleared diagnostics if a patient has been recently infected. The T2Lyme Panel developed by T2 Biosystems (Lexington, MA, USA) is a direct-from-blood molecular diagnostic test designed to run on the company’s FDA-cleared T2Dx Instrument and to detect Borrelia burgdorferi, the bacteria that causes Lyme disease. The T2Lyme Panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease. T2 Biosystems plans to complete development of, and commercialize, the T2Lyme Panel, with the goal of initiating marketing and sales in the U.S. as a Laboratory Developed Test (LDT) in 2023.

“We believe there is a significant market opportunity for a sensitive diagnostic test to detect early Lyme disease, and initial performance data on the T2Lyme Panel is very encouraging. Our decision to advance toward commercialization in 2023 follows two recent achievements: the receipt of a patent from the U.S. Patent and Trademark Office and the receipt of FDA Breakthrough Device Designation, both covering the T2Lyme Panel,” stated John Sperzel, Chairman and CEO of T2Biosystems. “While we plan to commence marketing and sales as an LDT in 2023, we intend to subsequently initiate a U.S clinical trial for the purpose of pursuing FDA clearance of the T2Lyme Panel. We believe the T2Lyme Panel will potentially allow clinicians to ensure patients receive appropriate therapy faster, and prevent the negative impact of a delay in delivery of appropriate therapy and the overuse of antibiotics.”

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