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Alphadera Labs Nabs FDA Emergency Use Authorization for COVID-19 RT-PCR Test

NEW YORK – Alphadera Labs obtained Emergency Use Authorization from the US Food and Drug Administration last week for a PCR assay to detect SARS-CoV-2.

The assay, named Alphadx SARS-CoV-2 RT-PCR Test, is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and mid-turbinate nasal swab specimens from individuals suspected of having COVID-19 by their healthcare provider.

Testing is limited to Alphadera’s CLIA facility, which is authorized to perform high-complexity testing, according to the FDA's letter of authorization.

Based in Houston, Alphadera offers COVID-19 testing for healthcare providers, travelers, individual patients, and public or private organizations, according to the company’s website.

The Scan

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