The T2Lyme™ Panel is designed to provide greater accuracy in the diagnosis of early Lyme disease, which may help improve care and lead to better patient outcomes, The T2Lyme™ Panel identifies the bacteria that cause Lyme disease directly from a patient’s blood. T2Lyme runs on the FDA-cleared T2Dx® Instrument, the same instrument currently used to run the FDA-cleared T2Bacteria® and T2Candida® Panels. The T2Lyme Panel was granted Breakthrough Device Designation by the United States Food and Drug Administration (FDA) on July 11, 2022. This designation brings us one step closer to providing clinicians with a valuable tool to detect Lyme disease earlier.
Undetected, underdiagnosed, and undertreated: Lyme disease is a tick-borne bacterial infection that, if left untreated, can cause chronic joint inflammation, neurological disorders, and cognitive defects. According to the Centers for Disease Control and Prevention (CDC), approximately 30,000 cases of Lyme disease are reported in the United States each year. However, due to poor diagnostic testing, the CDC estimates the actual number is closer to 476,000.1
Inadequate testing tools: 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.2 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.
A new assay for an accurate 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 data3 suggests that the T2Lyme Panel provides greater accuracy than other diagnostics for identifying Borrelia infections for patients suspected of having early-stage Lyme disease.