As originally posted at WSJ.com
LEXINGTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced positive results upon completion of the U.S. clinical evaluation for the T2Biothreat™ Panel.
“We believe the T2Biothreat Panel demonstrates very high sensitivity and specificity for a direct-from-blood multi-target biothreat product and is the only such product developed by a U.S. owned company,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We are extremely pleased with the results of the clinical evaluation. We have now shifted our attention to filing the submission with FDA for U.S. regulatory clearance and subsequently pursuing commercial sales, with the goal of protecting Americans from the threat of deliberate or naturally occurring outbreaks of biothreat pathogens.”
The T2Biothreat Panel is a fully-automated, direct-from-blood test designed to run on the T2Dx® Instrument and simultaneously detects six biothreat pathogens identified as threats by the U.S. Centers for Disease Control and Prevention, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii). Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.
In the event of a public health emergency involving biothreat pathogens, rapid and accurate diagnostic testing is expected to play a central role in minimizing health and economic impact. If not treated promptly, infections with these pathogens can result in mortality rates of 40-90%, as described in Medical Aspects of Biological Warfare and The Center for Food Security and Public Health. The T2Biothreat Panel is able to detect the aforementioned biothreat pathogens within 4 hours and provide clinicians with the needed information to appropriately treat infected patients.
The clinical evaluation was designed to support a U.S. Food and Drug Administration (FDA) submission and included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in working with biothreat pathogens, and Oschner Medical Center. Testing included over 470 negative blood samples from both healthy and febrile subjects and 350 contrived positive samples. The results of the clinical trial demonstrated very high sensitivity and specificity across all six targets.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50119C00053.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com.