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 Emergency Use Authorization (EUA) request to FDA
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, today announced the completion of validation of its COVID-19 molecular diagnostic test, 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 Emergency Use Authorization (EUA) request to FDA.
The T2SARS-CoV-2 Panel is designed to detect SARS-CoV-2, the virus that is responsible for COVID-19 infections. The T2SARS-CoV-2 Panel provides sample-to-answer results in less than two 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 U.S. 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,” said John Sperzel, President and Chief Executive Officer of T2 Biosystems. “Given the susceptibility of critically-ill COVID-19 patients to develop bacterial or fungal co-infections 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.”
The T2Dx Instrument can also run the Company’s FDA-cleared T2Bacteria Panel and T2Candida Panel. These panels can detect sepsis-causing pathogens, both bacterial and fungal respectively, directly from whole blood in three to five hours, without the need to wait for a blood culture, which typically takes days to provide results and is not as sensitive. By providing quicker results, the panels enable clinicians to target therapy faster than ever for their patients suspected of sepsis, leading to better patient outcomes, improved antibiotic stewardship, and reductions in length of stay in the hospital.
Source: Company Press Release