Panel is capable of detecting 99.99% of all currently identified SARS-CoV-2 viruses based on sequence alignments and in silico analysis
LEXINGTON, Mass., Feb. 04, 2021 (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—a molecular diagnostic test that detects SARS-CoV-2, the virus responsible for COVID-19 infections—is capable of detecting the Brazil (P.1) variant of the SARS-CoV-2 virus, which was recently confirmed to be present in the United States.
“We continue to actively monitor new variants of the COVID-19 virus to confirm that our technology remains a useful and reliable diagnostic tool for the many health care systems and people that need it during this time,” said T2 Biosystems’ President and CEO, John Sperzel.
Like the variants identified in the United Kingdom (B.1.1.7) and South Africa (B.1.351), the Brazil variant contains multiple mutations, most reflected in the S gene, which encodes the spike protein. A specific analysis of sequences for the Brazil variant 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 B.1.1.7 and B.1.351 variants.
To confirm that the T2SARS-CoV-2 Panel would detect the new Brazil (P.1) variant, an in silico analysis was performed using genome sequences available in the GISAID database. SARS-CoV-2 (P.1) sequences were evaluated for alignment with primer and probe sequences from T2SARS-CoV-2 Panel. This analysis demonstrated that the T2SARS-CoV-2 Panel should detect the Brazilian variant 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 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.
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 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.
Gina Kent, Vault Communications
Philip Trip Taylor, Gilmartin Group
Source: T2 Biosystems, Inc.