T2 Biosystems, Lexington, Mass, has announced the completion of validation of its covid-19 molecular diagnostic, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an FDA emergency use authorization.

John J. Sperzel III, T2 Biosystems.

John J. Sperzel III, T2 Biosystems.

The T2SARS-CoV-2 Panel provides sample-to-answer results in less than 2 hours, utilizing a nasopharyngeal swab sample. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%. The T2SARS-CoV-2 Panel runs on the Company’s FDA-cleared T2Dx Instrument, which is a fully-automated, random access system capable of performing seven tests simultaneously. “We are proud to announce the US launch of our molecular diagnostic test, the T2SARS-CoV-2 Panel, which has demonstrated excellent clinical performance. Adding this test to our existing sepsis-related portfolio illustrates our commitment to transformative diagnostics that improve the lives of patients,” says John Sperzel, president and chief executive officer of T2 Biosystems. “Given the susceptibility of critically-ill covid-19 patients to develop bacterial or fungal coinfections and secondary infections that can lead to sepsis, we believe our platform can be used to identify acute covid-19 infections and optimize outcomes for patients under intensive care.” For more information, visit T2 Biosystems.