T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel
The only FDA-cleared multi-target biothreat product developed and manufactured by a U.S. owned company
News provided byT2 Biosystems, Inc.
Sep 19, 2023, 9:00 AM ET
LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- 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).1 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.
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, the T2Biothreat™ 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 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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the ability of the T2Biothreat Panel to simultaneously detect six biothreat pathogens, product demand, the ability of the T2Biothreat Panel to protect Americans from the threat of deliberate or naturally occurring outbreaks of biothreat pathogens, and our ability to sell the T2Biothreat Panel to commercial markets and Governments, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Philip Trip Taylor, Gilmartin Group
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