Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial-stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, has seen its share price surging 18.16% in extended trading to $49.90. The rise, which came offsetting the decline of -3.32% the company has faced in the regular session, was all because of approval granted to its Covid-related test.
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Harnessing the intrinsic biology of the immune system is the main point of focus of Adaptive Biotechnologies to transform the way disease is diagnosed and treated. In ADPT’s view, the adaptive immune system is the most finely tuned natural way of detecting and treating most diseases, but as a result of being unable to properly decode its pattern, the system has been unavailable to medical professionals as a diagnostic and therapeutic tool. ADPT has developed three commercial products, and also various types of diseases such as cancer, infectious diseases, and autoimmune conditions, are being targeted by the company through its several product candidates.
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In a press release made on Friday, Adaptive announces that the FDA has approved an Emergency Use Authorization (EUA) of the company’s T-Detect COVID to confirm current as well as previous variants of COVID infection.
- This first-of-its-kind test in a TCR-Antigen Map collaboration with Microsoft (Nasdaq: MSFT) is the first indication from this collaboration.
- Approval of that EUA was based on a clinical validation study showing that T-Detect COVID displayed high sensitivity (97.1%) when used with RT-PCR from the date of diagnosis.
- Sensitivity is the degree to which a test can identify a true positive case correctly.
- T-Detect COVID also demonstrated 100% specificity which is the degree to which a test can identify a true negative case correctly.
- When there are no adequate, approved, and available alternatives to medical products in an emergency, the FDA can grant a EUA for use to diagnose, treat, or prevent serious diseases or conditions.