T2 Biosystems 2Q 2020
August 11, 2020
I would now like to provide an update on our COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel, which we launched commercially in the United States on June 30, 2020, the last day of the second quarter. We believe this new test will have a significant positive impact on our business by providing a new growth vehicle and driving increased sales of T2Dx Instruments in the U.S., which are being pre-positioned for future adoption of our existing sepsis products.
The T2SARS-CoV-2 Panel uses a nasopharyngeal swab sample and runs on our FDA-cleared T2Dx Instrument – which can perform seven tests simultaneously and provides results in less than two hours. Based upon testing in a clinical setting using known positive and negative patient samples, the T2SARS-CoV-2 Panel demonstrated sensitivity of 95% and specificity of 100%.
To understand how we plan to succeed in a growing COVID-19 diagnostic testing market, it’s important to understand the types of tests currently available, as well as the locations where COVID-19 testing is being performed.
The FDA issued a document in July 2020 titled “Coronavirus Testing Basics” describing two types of tests: diagnostic tests and antibody tests. According to the FDA, diagnostic tests can show if you have an active infection – and include molecular tests that detect the virus’s genetic material, such as the T2SARS-CoV-2 Panel, and antigen tests, that detect specific proteins on the surface of the virus. Antibody, or serology tests, look for antibodies that are made by your immune system in response to a threat such as a specific virus, not the actual virus. Antibodies can take several days or weeks to develop after an infection and may stay in your blood for several weeks or more after recovery.
According to the FDA, molecular tests can be used to diagnose an active COVID-19 infection. While antigen tests may also be used to diagnose active COVID-19 infections, the FDA cautions that antigen tests are more likely to miss an active infection, compared to molecular tests, and therefore should not be used to definitively rule out an active COVID-19 infection. Finally, according to the FDA, antibody tests cannot be used to diagnose active COVID-19 infections.
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