Advances U.S. Clinical Trials and FDA Submission for T2Resistance and T2Biothreat Panels
T2 Biosystems’ products include the T2Dx Instrument, T2Bacteria Panel, T2Candida Panel, T2Resistance Panel, and T2SARS-CoV-2 Panel. (Credit: T2 Biosystems, Inc.)
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, is providing an additional $3.7 million in funding for the multiple-year cost-share contract between BARDA and T2 Biosystems. The total potential BARDA funding if all contract options are exercised is $62.0 million, reflecting a reduction in the scope of work under contract option 3.
The additional funding will be used to advance the U.S. clinical trials for the T2Resistance Panel and T2Biothreat Panel and file submissions to the U.S. Food and Drug Administration (FDA) for U.S. regulatory clearance.
T2Resistance Panel: a direct-from-blood test panel designed to run on the T2Dx Instrument and simultaneously detect thirteen antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens, which are known to cause antibiotic-resistant infections.
T2Biothreat Panel: a direct-from-blood test panel designed to run on the T2Dx Instrument and simultaneously detect six biothreat pathogens, including: Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis, and Rickettsia prowazekii.
“We are pleased to advance the U.S. clinical trials for the T2Resistance Panel and T2Biothreat Panel, in collaboration with BARDA, and subsequently file submissions with FDA for U.S. regulatory clearance,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “These new products will expand the test menu on our T2Dx Instrument and have the potential to reduce the threat of antimicrobial resistance and protect the nation from biothreat pathogens.”
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50119C00053.
Source: Company Press Release