T2 Biosystems (TTOO) Announces FDA 510(k) Submission for T2Biothreat Panel
T2 Biosystems, Inc. (TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the United States Food and Drug Administration (FDA) for the company’s T2Biothreat™ Panel. The FDA submission follows the recently completed US clinical evaluation which demonstrated very high sensitivity and specificity, and included 350 contrived positive samples and over 470 negative blood samples from healthy and febrile subjects.
The T2Biothreat Panel is a fully automated, direct-from-blood test designed to operate on the FDA-cleared T2Dx® instrument and simultaneously detects six biothreat pathogens identified as threats by the Centers for Disease Control and Prevention of United States, including organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), snot (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis)And typhus (Rickettsia prowazekii). Rapid detection of these pathogens is essential to put infected patients on appropriate antimicrobial therapy and improve clinical outcomes.
“This submission to the FDA marks an important milestone in our commitment to protect Americans from the threat of deliberate or natural outbreaks of biothreat pathogens,” said John Sperzel, president 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 US company, and we look forward to going through the testing process. FDA premarket review for clearance.
In a public health emergency involving bio-threat pathogens, rapid and accurate diagnostic testing should play a central role in minimizing health and economic impact. If not treated promptly, infections with these pathogens can lead to mortality rates of 40-90%, as described in Medical Aspects of Biological Warfare and by the Center for Food Safety and Public Health. The T2Biothreat panel is able to detect the above mentioned biothreat pathogens within 4 hours and provide clinicians with the information needed to appropriately treat infected patients.
This project was funded in whole or in part by 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.