T2 Biosystems has filed a 510(k) premarket notification with the US Food and Drug Administration (FDA) for its T2Biothreat Panel.
The FDA submission comes after a recent US clinical evaluation showed that the panel has high sensitivity and specificity.
The trial involved testing 350 contrived positive samples and more than 470 negative blood samples that were taken from both healthy individuals and febrile subjects.
T2 Biosystems chairman and CEO John Sperzel said: “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.
“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-owned company and we look forward to working through the FDA premarket review process to obtain clearance.”
The T2Biothreat Panel is a fully automated and direct-from-blood test that operates on the FDA-approved T2Dx instrument.
It can simultaneously identify six biothreat pathogens, including organisms that cause tularemia (Francisella tularensis), glanders (Burkholderia mallei), anthrax (Bacillus anthracis), typhus (Rickettsia prowazekii), plague (Yersinia pestis) and melioidosis (Burkholderia pseudomallei).
These pathogens are recognised as potential dangers by the US Centers for Disease Control and Prevention and can be detected by the T2Biothreat Panel within four hours. The panel provides essential information to clinicians to better treat infected patients.
Biomedical Advanced Research and Development Authority Administration for Strategic Preparedness and Response and the US Department of Health and Human Services provided financial support for this project.