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Adaptive Biotechnologies Secures FDA EUA For COVID-19 T-Cell Response Test

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The FDA issued the Emergency Use Authorization (EUA) to Adaptive Biotechnologies Corp's (NASDAQ: ADPT) T-Detect COVID-19 Test on Friday. It will be used to determine whether an individual had been infected with SARS-CoV-2 in the past.

  • This T cell-based test is the first indication resulting from Adaptive's TCR-Antigen Map collaboration with Microsoft Corporation (NASDAQ: MSFT).
  • Unlike other tests that detect blood-based antibodies to determine the prior infection with the virus, the T-Detect COVID-19 Test leverages immune repertoire sequencing technology to identify individuals with an adaptive T-cell response to SARS-CoV-2, indicating recent or prior infection.
  • The EUA was issued based on a clinical validation study demonstrating a sensitivity of 97.1% from the date of COVID-19 diagnosis with RT-PCR. The test also showed a specificity of 100%.
  • The FDA noted that the test should not be used to diagnose current SARS-CoV-2 infection.
  • The blood-based test is for use by healthcare professionals on samples from individuals who experienced COVID-19 symptoms at least 15 days earlier, the FDA said. 
  • Price Action: ADPT shares are up 15.7% at $48.84 in the premarket session on the last check Monday.
 

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Posted-In: Covid-19Biotech News Health Care FDA General

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