T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced that its T2SARS-CoV-2™ Panel detects Omicron COVID-19 subvariants BA.1, BA.2, and BA.3.
LEXINGTON, Mass., Feb. 03, 2022 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced that its T2SARS-CoV-2™ Panel detects Omicron COVID-19 subvariants BA.1, BA.2, and BA.3.
According to the Centers for Disease Control and Prevention, the Omicron variant of the SARS-CoV-2 virus now accounts for 99.9% of all COVID-19 infections currently circulating in the United States.1 Although still considered an Omicron variant, there has recently been a worldwide increase in the Omicron subvariant BA.2. Since the Company’s November 30, 2021 announcement that the T2SARS-CoV-2 Panel detects the Omicron variant based on in silico analysis, T2 Biosystems has continued to monitor the ability of the T2SARS-CoV-2 Panel to detect all reported Omicron subvariants.
To confirm that the T2SARS-CoV-2 Panel would detect the new Omicron subvariants (BA.1, BA.2, and BA.3), T2 Biosystems performed in silico analysis using genetic sequences in the GISAID database. Based on the sequences that were available on February 1, 2022, over 5,000 BA.1, 2368 BA.2, and 266 BA.3 sequences were evaluated. This in silico analysis demonstrated that the T2SARS-CoV-2 Panel would be able to detect all Omicron subvariants.
“We are proud to announce that the T2SARS-CoV-2 Panel is capable of detecting all Omicron subvariants, enabling healthcare providers to make accurate decisions about their patients’ health,” said John Sperzel, Chairman and CEO at T2 Biosystems. “Despite the broad use of at-home COVID-19 antigen tests, hospitals continue to rely on molecular or PCR tests, including the T2SARS-CoV-2 Panel, to identify acute COVID-19 infections. As such, we are seeing high demand by U.S. hospitals for our T2SARS-CoV-2 Panel.”
The T2SARS-CoV-2 Panel, which has demonstrated a clinical sensitivity of 95 percent and a specificity of 100 percent, provides results in under two hours utilizing an upper respiratory swab sample. The test runs on the Company’s fully-automated T2Dx® Instrument, which is capable of performing seven tests simultaneously and up to sixty tests per day.
The T2Dx Instrument is also capable of running the FDA-cleared T2Bacteria® Panel and T2Candida® Panel, the only FDA-cleared assays able to detect sepsis-causing pathogens directly from whole blood in three to five hours, without the need to wait days for blood culture results. By providing timely results, the panels enable clinicians to target therapy faster for their patients suspected of sepsis, often before the second dose of antimicrobials are administered, leading to better patient outcomes, improved antimicrobial stewardship, and reductions in length of stay in the hospital.
The T2Bacteria® and T2Candida® Panels remain especially relevant during the pandemic, as data suggests that the COVID-19 virus is highly correlated with bacterial and fungal co-infections that may lead to sepsis, and death.
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, T2Bacteria® Panel, T2Resistance® Panel, and T2SARS-CoV-2™ Panel and are powered by the Company’s proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris™ Panel, 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 the T2SARS-CoV-2 Panel to detect multiple subvariants 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, 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
1http://dx.doi.org/10.15585/mmwr.mm7050e1
