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.