T2 Biosystems Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test
August 31 2020 - 4:05PM
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 95% and
specificity of 100%.
“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
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