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finance.yahoo.com/news/...-t-detect-covid-test-075215276.html
Adaptive’s T-Detect COVID Test Cleared For Emergency Use In US; Shares Pop 18%
support@smarteranalyst.com (Ben Mahaney)
Sun, March 7, 2021, 8:52 AM
"Adaptive Biotechnologies’ T-Detect COVID diagnostic test, which was designed to confirm a recent or prior COVID-19 infection, has been authorized for emergency use by the US Food and Drug Administration (FDA). Shares of the biotech company surged 18.2% in after-hours trading on March 5, after closing 3.3% lower on the day.
T-Detect is the first-in-class clinical T cell-based test introduced by Adaptive (ADPT) for detecting the SARS-CoV-2 virus infection in patients. Notably, T cells are the fastest responders in the immune system for detecting any virus.
The US regulator’s decision was based on a clinical validation study that demonstrated the test has a sensitivity of 97.1% from the date of diagnosis using RT-PCR and a specificity of 100%. Sensitivity refers to the identification of a correct positive case (true positive), while the specificity of the test identifies a negative case (true negative).
Adaptive CEO Chad Robins said, “The authorization of T-Detect COVID represents a true breakthrough for patients and a pivotal milestone for the diagnostic testing paradigm.”
“We have proven that it is possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications,” Robins added..."
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