T2 Biosystems announces launch of COVID-19 diagnostic test
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T2 Biosystems, Inc. announced the launch of T2SARS-CoV-2 Panel, a COVID-19 molecular diagnostic test, according to a press release issued by the company.
“We are proud to announce the U.S. launch of our molecular diagnostic test, the T2SARS-CoV-2 Panel, which has demonstrated excellent clinical performance,” John Sperzel, President and CEO of T2 Biosystems, said in a press release. “Adding this test to our existing sepsis-related portfolio illustrates our commitment to transformative diagnostics that improve the lives of patients.”
According to the press release, the panel, which uses nasopharyngeal swab samples to provide results in less than 2 hours, is being commercially distributed after validation-meeting requirements for an Emergency Use Authorization request to the FDA. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%.
“Given the susceptibility of critically ill [patients with] COVID-19 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,” Sperzel said.
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