T2 Biosystems (TTOO.Q) announced today that its T2SARS-CoV-2™ Panel is capable of detecting the Mu (B.1.621) (“Mu”) and Iota (B.1.526) (“Iota”) variants of the SARS-CoV-2 virus, which were recently confirmed to be present in the United States.
“We are proud to announce our technology is capable of detecting additional COVID-19 variants including Mu and Iota, enabling healthcare providers with the confidence to make more informed decisions about their patients’ health,” said T2 Biosystems’ Chairman and CEO, John Sperzel.
T2 Biosystems is a leader in the rapid detection of sepsis-causing pathogens, dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients efficiently. Aside from not having the most original name, the Company’s T2-SARS-CoV-2™ Panel is a test designed for the direct detection of SARS-CoV-2. The Panel is commercially available and was awarded Emergency Use Authorization (EUA) by the FDA on August 31, 2020. Prior analyses have demonstrated T2 Biosystems’ Panel to be capable of detecting the Delta (B.1.617.2) variant along with the B.1.1.7, B.1.351, and P.1 variants identified in the United Kingdom, South Africa, and Brazil respectively. With this in mind, in silico analyses performed using genome sequences demonstrated that the Panel should be capable of detecting the Mu and Iota variants of SARS-CoV-2.
Furthermore, the T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95% and specificity of 100%, is able to provide results in under two hours utilizing an upper respiratory swab sample. The test itself runs on the Company’s FDA approved and fully-automated T2Dx® Instrument, which is capable of performing seven tests simultaneously and up to sixty samples per day. As previously mentioned, T2 Biosystems in a leader in the rapid detection of sepsis-causing pathogens. Why? Well, T2 Biosystems’ T2Dx® Instrument is also capable of running the Company’s FDA-cleared T2Bacteria® Panel and T2Candida® Panel. These panels are the only FDA approved assays for the detection of sepsis-causing bacterial and fungal pathogens directly from whole blood in three to five hours.
T2 Biosystem recently reported its Q2 2021 Financial Results, boasting some impressive revenue growth. In fact, the Company achieved Q2 2021 revenue of $6.7 million, including product revenue of $3.7 million, representing growth of 162% and 253%, respectively, year-over-year. Considering T2 Biosystem has several marketed products under its belt, this isn’t too surprising. Looking forward, the Company expects revenue for the full year 2021 to be between $24 million and $26 million. As of June 30, 2021, T2 Biosystems’ cash and cash equivalents were sitting at $32,708,000. As the need for diagnostic tools capable of detecting the Mu and Iota variants of SARS-CoV-2 increases, T2 Biosystems in well positioned to experience growth relative to this demand.
T2 Biosystems’ share price opened at $1.07, up from a previous close of $0.86. The Company’s shares are up 18% and were trading at $1.025 as of 10:06 AM ET.