The T2Biothreat Panel will simultaneously detect six biothreat pathogens including Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis, and Rickettsia prowazekii
US-based in-vitro diagnostics company T2 Biosystems has received the US Food and Drug Administration (FDA) 510(k) approval for the T2Biothreat Panel.
The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-approved T2Dx Instrument and simultaneously detects six biothreat pathogens.
The six biothreat pathogens include Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis, and Rickettsia prowazekii.
The pathogens cause anthrax, tularemia, glanders, melioidosis, plague, and typhus diseases.
They have been identified as threats by the US Centres for Disease Control and Prevention (CDC) and as biological threats by the US Administration for Strategic Preparedness and Response (ASPR).
With the FDA 510(k) approval, the company is allowed to immediately start marketing and selling the T2Biothreat Panel in the US market.
T2 Biosystems chairman and CEO John Sperzel said: “The FDA 510(k) clearance for the T2Biothreat Panel marks a major milestone in our collaboration with the US Government, specifically Biomedical Advanced Research and Development Authority (BARDA).
“With the receipt of the FDA 510(k) clearance, which we believe demonstrates unparalleled sensitivity and specificity in direct-from-blood multi-target biothreat detection, we have immediately shifted our focus to commercialisation of the T2Biothreat Panel.”
T2 Biosystems said that its T2Biothreat Panel is the first and only FDA-approved product to simultaneously detect these six high-priority biothreat pathogens.
The FDA approval is based on the clinical evaluation of the T2Biothreat Panel at MRIGlobal, a BL-3 laboratory specialising in biothreat pathogens, and Ochsner Medical Centre.
The clinical evaluation evaluated the sensitivity and specificity of the panel to detect targets in blood samples containing a range of bacterial concentrations.
In the event of a public health emergency involving biothreat pathogens, rapid and accurate diagnostic testing is expected to play a central role in achieving targeted antimicrobial treatment, improving patient outcomes, and minimising economic impact.
The T2Biothreat Panel can detect the six aforementioned biothreat pathogens within four hours providing clinicians with the needed information to appropriately treat infected patients.
The US Department of Health and Human Services (HHS), ASPR and Biomedical Advanced Research and Development Authority (BARDA) offered financial support for the project.