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NEW YORK – Avellino Labs on March 25 received Emergency Use Authorization for its coronavirus real-time PCR diagnostic test from the US Food and Drug Administration.

The assay, called AvellinoCoV2 test, is designed for the detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19, from nasopharyngeal and oropharyngeal swab specimens from individuals suspected by their healthcare provider of being infected with the virus.

According to the EUA, the test may only be performed by Avellino's CLIA laboratory. The company is based in Menlo Park, California.

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.