The T2Biothreat Panel is the first and only FDA-cleared product able to simultaneously detect these six high-priority biothreat pathogens, and the only FDA-cleared multi-target biothreat product developed and manufactured by a U.S. owned company. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.
The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the T2Dx instrument. The test can detect and differentiate between six biothreat pathogens in a single sample, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and epidemic typhus (Rickettsia prowazekii). These biothreat pathogens are categorized as high-priority threats to U.S. health security.
The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Ochsner Medical Center. The clinical evaluation assessed the sensitivity and specificity of the panel to detect targets in blood samples containing a range of bacterial concentrations. The positive percent agreement for all targets at 1-3 times the limit of detection was 100% for all targets except F. tularensis, which was 94.3%. The negative percent agreement for all six targets in healthy or febrile blood containing no bacteria was 100%.
The Biomedical Advanced Research and Development Authority (BARDA) began supporting T2 Biosystems in September 2019 to develop highly sensitive diagnostic assays to detect biothreat pathogens and genes conferring resistance to antimicrobials, made possible by T2’s Magnetic Resonance (T2MR) detection technology. The program included development of assays for use with the existing T2Dx instrument, along with a next-generation high-throughput instrument and assays. This effort is part of BARDA’s mission to prepare for potential future biothreat outbreaks.
“The FDA 510(k) clearance for the T2Biothreat Panel marks a major milestone in our collaboration with the U.S. Government, specifically Biomedical Advanced Research and Development Authority (BARDA), and our commitment to protect Americans from the consequences of deliberate or naturally occurring outbreaks of these biothreat pathogens. With 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 commercialization of the T2Biothreat Panel, which we intend to sell to commercial markets and governments.”John Sperzel, Chairman and CEO at T2 Biosystems
If not treated promptly, infections with the pathogens included on the T2Biothreat Panel can result in mortality rates of 40-90%, according to Medical Aspects of Biological Warfare and The Center for Food Security and Public Health (CFSPH). 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 minimizing economic impact. The T2Biothreat Panel is able to detect the six aforementioned biothreat pathogens within four hours providing clinicians with the needed information to appropriately treat infected patients.
The six biothreat pathogens detected by the T2Biothreat Panel are identified as biological threats by the U.S. Administration for Strategic Preparedness and Response (ASPR). ASPR engages partners through Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) activities to share information and coordinate plans and actions to ensure the nation has and can use medical countermeasures to protect Americans during disasters and emergencies resulting from known and unknown chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases.