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Avellino Labs Receives FDA Emergency Use Authorization for Coronavirus Test

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.

Last fall, Avellino received CLIA certification for its lab, enabling it to process samples for its AvaGen sequencing test for keratoconus and corneal dystrophies.