T2 Biosystems T2SARS-CoV-2™ Panel Detects Omicron Variant

Rhea-AI Summary

T2 Biosystems (NASDAQ:TTOO) announced that its T2SARS-CoV-2™ Panel successfully detects the Omicron COVID-19 variant (B.1.1.529). The Omicron variant, designated as a 'variant of concern' by the WHO, has over 30 mutations and has spread to 20 countries. The T2SARS-CoV-2 Panel shows 95% sensitivity and 100% specificity, providing results in under two hours. This capability supports clinicians in managing sepsis-related complications during the pandemic. T2 Biosystems aims to enhance patient care while reducing healthcare costs with its innovative diagnostic solutions.

Positive

• T2SARS-CoV-2 Panel detects Omicron variant, expanding clinical relevance.
• Demonstrated clinical sensitivity of 95% and specificity of 100%.
• Results are available in under two hours, aiding faster healthcare decisions.
• T2Dx Instrument processes multiple tests simultaneously, increasing efficiency.

Negative

• None.

LEXINGTON, Mass., Dec. 01, 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 detects the Omicron COVID-19 variant (B.1.1.529).

The World Health Organization has designated the Omicron variant as a SARS-CoV-2 “variant of concern” with more than 30 mutations in the spike protein region. The variant was initially identified in South Africa and has already been detected across 20 countries.

To confirm that the T2SARS-CoV-2 Panel would detect the new Omicron (B.1.1.529) variant, in silico analysis was performed using sequences in the GISAID database. SARS-CoV-2 (B.1.1.529) sequences were evaluated for alignment with primer and probe sequences from T2SARS-CoV-2 Panel. These analyses demonstrated that none of the new B.1.1.529 mutations occur within the region targeted by the T2SARS-CoV-2 Panel.

“We are proud to announce our technology is capable of detecting additional COVID-19 variants including Omicron, enabling healthcare providers with the confidence to make more informed decisions about their patients’ health,” said T2 Biosystems’ Chairman and CEO, John Sperzel.

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.

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

FAQ

What is the significance of T2 Biosystems detecting the Omicron variant with T2SARS-CoV-2™ Panel?

The detection indicates T2 Biosystems' capability to identify new COVID-19 variants, which assists healthcare providers in making informed treatment decisions.

What are the sensitivity and specificity of the T2SARS-CoV-2 Panel?

The T2SARS-CoV-2 Panel has a clinical sensitivity of 95% and a specificity of 100%.

How quickly can T2SARS-CoV-2 testing provide results?

Results from the T2SARS-CoV-2 Panel can be obtained in under two hours.

How does T2 Biosystems' technology contribute to combating sepsis in COVID-19 patients?

By providing quick and accurate results for detecting pathogens, the technology enables clinicians to initiate targeted therapy faster, potentially improving patient outcomes.

What other panels can be run on the T2Dx Instrument?

The T2Dx Instrument can also run the T2Bacteria® Panel and T2Candida® Panel, addressing various sepsis-causing bacterial and fungal pathogens.