Direct-From-Blood Molecular Diagnostic Test Enables Early Detection of Lyme Disease

Lyme disease is a bacterial infection caused by Borrelia pathogens and is transmitted to humans through the bite of infected ticks. It is considered the most common vector borne illness in the Northern Hemisphere. Borrelia burgdorferi is most commonly associated with Lyme disease in North America, while Borrelia afzelii and Borrelia garinii cause most Lyme infections in Europe and Asia. Typical symptoms include fever, headache, fatigue and skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart and the nervous system. Currently, there are no sensitive FDA-cleared diagnostic tests for the detection of early Lyme disease. Laboratory diagnosis of Lyme disease has traditionally used a two-tier process of enzyme immunoassay and western blot for detecting the presence of antibodies against Borrelia burgdorferi in a patient’s blood. Antibodies are specific proteins produced by the body in response to an 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. Now, a direct-from-blood molecular diagnostic test that simultaneously detects the bacteria causing Lyme disease can provide clinicians with a valuable tool to detect Lyme disease earlier.

T2 Biosystems, Inc.’s (Lexington, MA, USA) T2Lyme Panel simultaneously detects the bacteria that cause Lyme disease directly from a patient’s blood. The T2Lyme Panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease. Designed to run on the FDA-cleared T2Dx Instrument, the test provides greater accuracy in the diagnosis of early Lyme disease, which may help improve care and lead to better patient outcomes.

Approximately 3.4 million 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. Because current diagnostic testing for Lyme disease is so poor, the CDC recommends that the diagnosis remain a clinical one, based on a patient’s symptoms and history, with additional tests only used to provide supporting evidence for the diagnosis. For patients who are infected with the bacteria that cause Lyme disease, early diagnosis and appropriate treatment can prevent or reduce these complications and the significant associated costs. Preclinical data suggests that the T2Lyme Panel provides greater accuracy than other diagnostics for identifying Borrelia infections for patients suspected of having early-stage Lyme disease. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the T2Lyme Panel.

“We are pleased with the FDA’s decision to grant Breakthrough Device Designation for the T2Lyme Panel, as it brings us one step closer to providing clinicians with a valuable tool to detect Lyme disease earlier. Similar to the value proposition of our sepsis panels, we believe the T2Lyme Panel will allow clinicians to ensure patients receive the appropriate therapy faster, and prevent the negative impact of a delay in delivery of appropriate therapy and the overuse of antibiotics,” said John Sperzel, Chairman and CEO of T2Biosystems. “This achievement follows the decision by the U.S. Patent and Trademark Office to grant T2 Biosystems a patent covering the T2Lyme Panel, ‘NMR Methods and Systems for the Rapid Detection of Tick-Borne Pathogens’ and we look forward to further advancements with our T2Lyme Panel.”

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T2 Biosystems, Inc. 

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