T2 Biosystems Announces the Initiation of the T2Biothreat® Panel Clinical Trial
T2 Biosystems, Inc. (NASDAQ:TTOO) has initiated a U.S. clinical trial for its T2Biothreat® Panel, aimed at detecting six biothreat pathogens in blood samples within 3-5 hours. This panel, which operates on the T2Dx® Instrument, targets pathogens identified as threats by the U.S. Government, such as B. anthracis and Y. pestis. The company plans to submit for FDA approval in 2022, with trial costs estimated between $400,000 to $500,000. T2 Biosystems expresses confidence in the trial's success and emphasizes the importance of their technology in national safety.
- Initiation of a clinical trial for T2Biothreat® Panel, addressing national biothreat concerns.
- Expected FDA submission for the T2Biothreat® Panel in 2022, signaling progress in product development.
- Positive results could enhance the company's market position in rapid diagnostics.
- Clinical trial costs estimated between $400,000 and $500,000, which may impact short-term finances.
- Potential for delays in FDA submission and approval process could affect market entry plans.
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 initation of a U.S. clinical trial evaluating the performance of its T2Biothreat® Panel designed to support a submission to the U.S. Food and Drug Administration (FDA).
The T2Biothreat® Panel, which runs on T2 Biosystems’ T2Dx® Instrument, is a direct-from-blood test panel that provides results in 3-5 hours and simultaneously detects six biothreat pathogens identified as threats by the U.S. Government, including B. anthracis, F. tularensis, Burkholderia spp., Y. pestis, and R. prowazekii.
The Company plans to file the FDA submission for the T2Biothreat® Panel in 2022 following completion of the clinical trial, which includes positive samples being prepared and analyzed at a high-containment Biosafety Level 3 laboratory and negative samples being analyzed at a single site, and is estimated to cost T2 Biosystems
“We are pleased to initiate the clinical trial for our novel T2Biothreat® Panel as we continue to advance our product development strategy ahead of schedule,” said John Sperzel, Chairman and CEO at T2 Biosystems. “We are confident that the results will highlight the versatility of our technology, including our T2Dx® Instrument, and its unique ability to help protect our nation in the face of a biothreat incident. We thank BARDA for its continued support and collaboration as we expand our portfolio of blood culture independent rapid diagnostic products.”
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 Biosytems’ products to help protect our nation in the face of a biothreat incident, 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:
Philip Trip Taylor, Gilmartin Group
philip@gilmartinIR.com
415-937-5406
FAQ
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