T2 Biosystems Announces U.S. Launch of COVID-19 Diagnostic Test
June 30 2020 - 4:06PM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens, today announced the
completion of validation of its COVID-19 molecular diagnostic test,
the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems
under a license agreement with the Center of Discovery and
Innovation at Hackensack Meridian Health and is being commercially
distributed after validation meeting requirements for an Emergency
Use Authorization (EUA) request to FDA.
The T2SARS-CoV-2 Panel is designed to detect SARS-CoV-2, the
virus that is responsible for COVID-19 infections. The T2SARS-CoV-2
Panel provides sample-to-answer results in less than two hours,
utilizing a nasopharyngeal swab sample. Clinical testing on known
positive and negative patient samples showed a sensitivity of 95%
and specificity of 100%. The T2SARS-CoV-2 Panel runs on the
Company’s FDA-cleared T2Dx® Instrument, which is a fully-automated,
random access system capable of performing seven tests
simultaneously.
“We are proud to announce the U.S. launch of our molecular
diagnostic test, the T2SARS-CoV-2 Panel, which has demonstrated
excellent clinical performance. Adding this test to our existing
sepsis-related portfolio illustrates our commitment to
transformative diagnostics that improve the lives of patients,”
said John Sperzel, President and Chief Executive Officer of T2
Biosystems. “Given the susceptibility of critically-ill COVID-19
patients to develop bacterial or fungal co-infections and secondary
infections that can lead to sepsis, we believe our platform can be
used to identify acute COVID-19 infections, and optimize outcomes
for patients under intensive care.”
The T2Dx Instrument can also run the Company’s FDA-cleared
T2Bacteria® Panel and T2Candida® Panel. These panels can detect
sepsis-causing pathogens, both bacterial and fungal respectively,
directly from whole blood in three to five hours, without the need
to wait for a blood culture, which typically takes days to provide
results and is not as sensitive. By providing quicker results, the
panels enable clinicians to target therapy faster than ever for
their patients suspected of sepsis, leading to better patient
outcomes, improved antibiotic 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, as well as 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, 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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