T2 Biosystems Announces the Initiation of the T2Resistance® Panel Clinical Trial
T2 Biosystems, a leader in rapid sepsis detection, has initiated a U.S. clinical trial for its T2Resistance® Panel, which identifies 13 antibiotic resistance genes directly from blood in 3-5 hours. This move aims to support an FDA submission in 2022, following the evaluation of up to 1,500 patients across 10 hospitals. The trial is projected to cost $2.5 million. With FDA's 'Breakthrough Device' designation, the T2Resistance® Panel could revolutionize treatment for antibiotic-resistant infections, addressing a major public health threat.
- Initiation of U.S. clinical trial for T2Resistance® Panel ahead of schedule.
- Potential for rapid identification of antibiotic resistance directly from blood, enhancing treatment efficacy.
- FDA's 'Breakthrough Device' designation indicates strong regulatory support.
- Clinical trial costs estimated at $2.5 million, impacting financial resources.
- Dependence on successful trial outcomes to support FDA submission for commercialization.
LEXINGTON, Mass., Jan. 11, 2022 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced the initiation of a U.S. multi-site clinical trial evaluating the performance of its T2Resistance® Panel designed to support a submission to the U.S. Food and Drug Administration (FDA).
The T2Resistance® Panel, which runs on T2 Biosystems’ T2Dx® Instrument, is a direct-from-blood test panel that detects 13 antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens, which are known to cause antibiotic-resistant infections that may lead to sepsis, and provides results in 3-5 hours without the need to wait for blood culture. The T2Resistance® Panel is commercially available in Europe under a CE mark and was granted “Breakthrough Device” designation from the FDA, which provides for a prioritized FDA review process.
The Company plans to file the FDA submission for the T2Resistance® Panel in 2022 following completion of the clinical trial, which will include up to 1,500 patients across 10 U.S. hospitals. The trial is estimated to cost T2 Biosystems
“We are pleased to have initiated the U.S. clinical trial for the T2Resistance® Panel ahead of schedule, which should provide a path to file the FDA submission during 2022,” said John Sperzel, Chairman and CEO at T2 Biosystems. “We believe the detection of antibiotic resistant genes directly from whole blood in 3-5 hours would be a game changer in the U.S., as data show that each hour of delayed targeted treatment increases mortality risk by up to
Antimicrobial resistance is considered one of the greatest threats to global health. The U.S. Centers for Disease Control and Prevention estimates at least 2.8 million people are infected with antimicrobial-resistant bacteria or fungi in the U.S. each year, and more than 35,000 die as a result. Prudent use of antimicrobials reduces the risk of developing antimicrobial resistance and leads to a positive public health impact. Current standard of care therapy, blood culturing and the use of broad spectrum antibiotics, contributes to the overuse of antimicrobials and drives increases in global drug resistance rates. A culture-independent diagnostic would save critical time, improve therapeutic decision making by clinicians and improve patient outcome.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50119C00053.
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, 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, T2Candida® Panel, the T2Bacteria® 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 T2Cauris™ Panel, and T2Lyme™ Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.
Forward-Looking Statements
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 T2’s culture-independent diagnostics to allow clinicians to achieve appropriate targeted therapy for their patients, faster than is possible with blood culture, the current standard of care, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “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, 2020, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2021, and other filings the Company makes with the SEC from time to time. 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.
Media Contact:
Meagan Dominick, Vault Communications
mdominick@vaultcommunications.com
773-369-4255
Investor Contact:
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415-937-5406
FAQ
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