T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Company’s T2Biothreat Panel. The FDA submission follows the recently completed U.S. clinical evaluation that demonstrated very high sensitivity and specificity, and included 350 contrived positive samples and over 470 negative blood samples from both healthy and febrile subjects.
The T2Biothreat Panel is a fully-automated, direct-from-blood test designed to run on the FDA-cleared T2Dx Instrument and simultaneously detects six biothreat pathogens identified as threats by the U.S. Centers for Disease Control and Prevention, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii). Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.
“This FDA submission marks an important milestone in our commitment to protect Americans from the threat of deliberate or naturally occurring outbreaks of biothreat pathogens,” says John Sperzel, chairman and CEO of T2 Biosystems. “We believe the T2Biothreat Panel demonstrates very high sensitivity and specificity for a direct-from-blood multi-target biothreat product, the only such product developed by a U.S.-owned company, and we look forward to working through the FDA premarket review process to obtain clearance.”
In a public health emergency involving biothreat pathogens, rapid and accurate diagnostic testing is expected to play a central role in minimizing health and economic impact. If not treated promptly, infections with these pathogens can result in mortality rates of 40-90%, as described in Medical Aspects of Biological Warfare and by the Center for Food Security and Public Health. The T2Biothreat Panel is able to detect the aforementioned biothreat pathogens within 4 hours and provide clinicians with the needed information to appropriately treat infected patients.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50119C00053.