New Data Suggests T2 Biosystems’ T2Lyme Panel is More Accurate than Other Diagnostics for Identifying Borrelia Infections for Patients Suspected of Having Early Lyme Disease

- September 26th, 2018

T2 Biosystems (NASDAQ:TTOO), a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, announced today new data suggesting the T2Lyme Panel is more accurate than other diagnostics for identifying Borrelia infections for patients suspected of having early Lyme disease. Run on the fully automated FDA-cleared T2Dx® Instrument, the T2Lyme Panel is … Continued

T2 Biosystems (NASDAQ:TTOO), a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, announced today new data suggesting the T2Lyme Panel is more accurate than other diagnostics for identifying Borrelia infections for patients suspected of having early Lyme disease. Run on the fully automated FDA-cleared T2Dx® Instrument, the T2Lyme Panel is designed to detect Lyme disease-causing bacteria in 3 to 5 hours.

As quoted in the press release:

The data from a 2017 pre-clinical study evaluated 21 patients enrolled with an erythema migrans (EM) rash with suspected early Lyme disease and assessed with multiple Lyme diagnostics. The study compares various diagnostic methods with the T2Lyme Panel, in determining a definitive Borrelia infection, using tissue biopsy culture from the EM rash. Of all the diagnostics tested, the T2Lyme Panel blood test was the most accurate compared to tissue culture with a 78% positive percent agreement (PPA) and 100% negative percent agreement (NPA). Two-tier serology, the currently recommended diagnostic, had a 56% PPA and 92% NPA compared to tissue culture, while blood polymerase chain reaction (PCR) did not correctly identify any positives. Eight (38%) patients were negative for all diagnostics. The 100% NPA of the T2Lyme Panel indicates greater specificity over serology resulting in less incidence of false positive results. Overall, the T2Lyme Panel has been evaluated against 558 negative samples with no false-positive results.

“We are excited that the pre-clinical data is promising as the T2Lyme Panel performed better than all other diagnostics tested and suggests the panel can improve upon existing Lyme diagnostic tests,” said Dr. Nitin Damle, co-author of the study and Clinical Associate Professor of Medicine, Alpert Medical School at Brown University. “The strong specificity suggests clinicians can have a high degree of confidence that a T2Lyme positive is a true infection.”

Click here to read the full press release.

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