T2Lyme Panel

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 Borrelia burgdorferi, the bacteria that is the most common cause of Lyme disease in the U.S., directly from a patient’s blood. T2 Biosystems plans to commercialize this panel as a laboratory developed test (LDT). 

The T2Lyme Panel for the T2Dx Instrument was granted Breakthrough Device Designation by the United States Food and Drug Administration (FDA) on July 11, 2022.  

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 on the T2Lyme Panel for the T2Dx suggests that the Panel provides greater accuracy than other diagnostics for identifying Borrelia  infections for patients suspected of having early-stage Lyme disease. 

T2 Biosystems was named a Phase 2 winner in HHS and the Steven & Alexandra Cohen Foundation’s LymeX Diagnostics Prize

We are proud to announce that the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation have announced T2 Biosystems as a Phase 2 winner in the LymeX Diagnostics Prize, a prize competition to accelerate the development of Lyme disease diagnostics. 

Visit LymeXDiagnosticsPrize.com for more information.