 |
| Image created by Dr. Michael J. Miller |
T2 Biosystems, Inc., 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 multiple variants of the SARS-CoV-2 virus most recently identified in the United Kingdom, South Africa, and the United States.
“As new strains of the COVID-19 virus emerge, it is critical that we ensure our technology continues to be an effective diagnostic solution during the ongoing pandemic,” said T2 Biosystems’ President and CEO, John Sperzel. “I’m proud that we can confidently say, after extensive analysis, that our T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent, can continue to help impact lives by detecting multiple variants of the SARS-CoV-2 virus.”
Both the variants identified in the United Kingdom (B.1.1.7) and South Africa (B.1.351) contain multiple mutations, most reflected in the S gene, which encodes the spike protein. To confirm that the T2SARS-CoV-2 Panel would detect these variants and other potential mutations of SARS-CoV-2 viruses, an in silico analysis was performed using genome sequences available in the National Center for Biotechnology Information (NCBI) nucleotide database and GISAID database.
Over 42,000 genome sequences for SARS-CoV-2 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 99.99% of all SARS-CoV-2 viruses based on sequence alignments. A specific analysis of sequences for B.1.1.7 and B.1.351 variants confirmed that the T2SARS-CoV-2 Panel should be able to detect these variants.
The T2SARS-CoV-2 Panel 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.