The T2Lyme™ Panel is designed to provide greater accuracy in the diagnosis of Lyme disease, which may help improve patient care, lead to better outcomes, and reduce or eliminate the significant costs associated with the disease. The Panel is being developed through a partnership between T2 Biosystems and Canon U.S. Life Sciences. It helps to identify the bacteria that cause Lyme disease directly from a patient’s blood. T2Lyme runs on the FDA-cleared and CE-marked T2Dx® Instrument, the same instrument currently used to run the FDA-cleared and CE-marked T2Bacteria® and T2Candida® Panels.
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 360,000.1
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. T2 Biosystems is currently enrolling patients in an FDA clinical trial for the T2Lyme Panel to evaluate the clinical performance of T2Lyme compared to skin biopsy and/or detection of the C6 antigen. The clinical trial will continue in 2019.