The T2Biothreat Panel is said to be a fully automated, direct-from-blood test designed to detect six biothreat pathogens recognised as threats by the US Centres for Disease Control and Prevention
Diagnostic products maker T2 Biosystems has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its T2Biothreat Panel.
The T2Biothreat Panel is said to be a fully automated, direct-from-blood test designed to run on the FDA-cleared T2Dx Instrument.
According to T2 Biosystems, the panel simultaneously detects six biothreat pathogens recognised as threats by the US Centres for Disease Control and Prevention.
It can detect organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii).
The diagnostic products maker said that the rapid detection of these pathogens will help provide appropriate antimicrobial therapy to infected patients and improve clinical outcomes.
The FDA filing comes after the recently concluded US clinical review. It included 350 contrived positive samples and over 470 negative blood samples from both healthy and febrile people.
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 can identify the biothreat pathogens in around four hours, providing clinicians with the knowledge they need to treat affected patients effectively.
The US Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority (BARDA) have funded this project.
T2 Biosystems also provides products like the T2Bacteria Panel, the T2Dx Instrument, the T2Candida Panel, the T2Resistance Panel, and the T2SARS-CoV-2 Panel. The portfolio is powered by the proprietary T2 Magnetic Resonance (T2MR) technology.
The company has an active pipeline of future products like the T2Biothreat Panel, the T2Cauris Panel, and the T2Lyme Panel.
In July 2022, the diagnostic products maker secured the Breakthrough Device Designation from the FDA for its T2Lyme Panel.