T2 Biosystems T2SARS-CoV-2™ Panel Proves Capable of Detecting the Mu B.1.621 and Iota B.1.526 Variants of the SARS-CoV-2 Virus
September 09 2021 - 4:52PM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens, today announced that its
T2SARS-CoV-2™ Panel—a molecular diagnostic test that detects
SARS-CoV-2, the virus responsible for COVID-19 infections—is
capable of detecting the Mu (B.1.621) and Iota (B.1.526) variants
of the SARS-CoV-2 virus, which were recently confirmed to be
present in the United States.
“We are proud to announce our technology is capable of detecting
additional COVID-19 variants including Mu and Iota, enabling
healthcare providers with the confidence to make more informed
decisions about their patients’ health,” said T2 Biosystems’
Chairman and CEO, John Sperzel.
Like the variants identified in the United Kingdom (B.1.1.7),
South Africa (B.1.351), and Brazil (P.1), the Mu and Iota variants
contain multiple mutations, most reflected in the S gene, which
encodes the spike protein. Specific analyses of sequences for the
Mu and Iota variants confirmed that the T2SARS-CoV-2 Panel should
be able to detect this variant with high confidence and
reliability. This analysis expands the proven utility of the panel
beyond the previously announced capability to detect the Delta
(B.1.617.2) variant along with the B.1.1.7, B.1.351, and P.1
variants.
To confirm that the T2SARS-CoV-2 Panel would detect the new Mu
(B.1.621) and Iota (B.1.526) variants, in silico analyses was
performed using genome sequences available in the GISAID database.
SARS-CoV-2 (B.1.621) and (B.1.526) sequences were evaluated for
alignment with primer and probe sequences from T2SARS-CoV-2 Panel.
These analyses demonstrated that the T2SARS-CoV-2 Panel should
detect the Mu and Iota variants of SARS-CoV-2.
The T2SARS-CoV-2 Panel, which has demonstrated clinical
sensitivity of 95 percent and specificity of 100 percent, provides
results in under two hours utilizing an upper respiratory swab
sample. The test runs on the Company’s FDA-cleared and
fully-automated T2Dx® Instrument, which is capable of performing
seven tests simultaneously and up to sixty samples per day.
The same T2Dx Instrument is also capable of running the
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 medicine is
administered, leading to better patient outcomes, improved
antimicrobial stewardship, and reductions in length of stay in the
hospital.
These additional panels remain especially clinically relevant
during the pandemic, as data suggests that the COVID-19 virus can
lead to sepsis, and death.
About T2 BiosystemsT2 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 StatementsThis 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
the T2SARS-CoV-2 Panel to detect multiple variants of the
SARS-CoV-2 virus, 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
Communicationsgkent@vaultcommunications.com 610-455-2763
Investor Contact:Philip Trip Taylor, Gilmartin
Groupphilip@gilmartinIR.com415-937-5406
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