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Clear Labs Nanopore Sequencing Coronavirus Test Gets FDA Emergency Use Authorization

NEW YORK — Clear Labs said on Thursday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Clear Dx SARS-CoV-2 novel descriptive diagnostic, the first nanopore sequencing-based test for SARS-CoV-2 to receive EUA.

The Clear Dx test uses RNA extracted from a swab specimen, followed by target amplification, nanopore sequencing on an Oxford Nanopore GridIon sequencer, and bioinformatics analysis. The test is used both for infection diagnosis and the monitoring of mutations that may confer drug resistance, enhance virulence, and cause loss of diagnostic targets for PCR, according to the San Carlos, California-based company.

"The powerful combination of our genomics-based assay and bioinformatics software means that laboratories, hospitals, and pharmaceutical companies have access to accurate, up-to-date molecular data that will help them better understand and therefore combat the virus," Clear Labs Cofounder and CEO Sasan Amini said in a statement.

In May, Clear Labs announced $18 million in strategic funding, part of which it is using to commercialize the SARS-CoV-2 test.