T2 Biosystems Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test
T2 Biosystems, Inc. (NASDAQ:TTOO) has received Emergency Use Authorization (EUA) from the FDA for its COVID-19 diagnostic test, the T2SARS-CoV-2™ Panel. This test detects the SARS-CoV-2 virus and delivers results in under two hours from a nasopharyngeal swab. It demonstrated a sensitivity of 95% and specificity of 100%. The company is increasing manufacturing capacity to meet anticipated demand. The T2Dx® Instrument can also conduct tests for sepsis-causing pathogens, aiding in the timely treatment of critically ill patients.
- FDA granted Emergency Use Authorization for the T2SARS-CoV-2™ Panel.
- The test provides results in under two hours with high sensitivity (95%) and specificity (100%).
- Expansion of manufacturing capacity to meet increased demand.
- T2Dx® Instrument can perform multiple tests simultaneously, enhancing efficiency.
- None.
LEXINGTON, Mass., Aug. 31, 2020 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its COVID-19 molecular diagnostic test, the T2SARS-CoV-2™ Panel.
The T2SARS-CoV-2 Panel is a molecular diagnostic test that detects SARS-CoV-2, the virus responsible for COVID-19 infections, and provides results in under two hours utilizing a nasopharyngeal swab sample. The test runs on the Company’s FDA-cleared and fully-automated T2Dx® Instrument, which is capable of performing seven tests simultaneously. Clinical testing on both positive and negative patient samples demonstrated a sensitivity of
“We believe the Emergency Use Authorization for our COVID-19 molecular diagnostic test will lead to greater adoption of our technology by U.S. hospitals, and we are expanding manufacturing capacity to meet the anticipated demand,” said John Sperzel, President and Chief Executive Officer of T2 Biosystems. “As critically-ill COVID-19 patients are susceptible to bacterial or fungal co-infections and secondary infections that can lead to sepsis, we believe our platform can be an effective tool to identify acute COVID-19 infections, and optimize outcomes for hospitalized patients under intensive care.”
The T2Dx Instrument can also run the Company’s FDA-cleared T2Bacteria® Panel and T2Candida® Panel. These panels are the only FDA-cleared assays for the detection of sepsis-causing bacterial and fungal pathogens directly from whole blood in three to five hours, without the need to wait days for blood culture results. By providing quicker results, the panels enable clinicians to target therapy faster for their patients suspected of sepsis, often before the second dose of antimicrobial is administered, leading to better patient outcomes, improved antimicrobial stewardship, and reductions in length of stay in the hospital.
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 T2SARS-CoV-2 Panel’s results and its adoption by U.S. hospitals, the T2Dx® Instrument’s simultaneous testing capacity, the ability to target patients under intensive care, the benefit of early identification of bacterial or fungal infections, 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, 2019, filed with the U.S. Securities and Exchange Commission, or SEC, on March 16, 2020, 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:
Gina Kent, Vault Communications
gkent@vaultcommunications.com
610-455-2763
Investor Contact:
Philip Trip Taylor, Gilmartin Group
philip@gilmartinIR.com
415-937-5406
FAQ
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