T2 Biosystems (TTOO) T2SARS-CoV-2 Panel Proves Capable of Detecting the Brazil P.1 Variant of the SARS-CoV-2 Virus

February 4, 2021 4:18 PM EST
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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.

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