T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel

Original from: T2 Biosystems

T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel. 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 FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat pathogens, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii). These pathogens have been identified as threats by the U.S. Centers for Disease Control and Prevention and identified as material biological threats under section 319-2(c)(2)(A)(ii) of the Public Health Service Act.

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 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 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,” stated John Sperzel, Chairman and CEO at T2 Biosystems. “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.”

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. 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.

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services(HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50119C00053.  

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Source: T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel