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.
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.