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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.

The Scan

Booster for At-Risk

The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people 65 and older or at increased risk.

Preprints OK to Mention Again

Nature News reports the Australian Research Council has changed its new policy and now allows preprints to be cited in grant applications.

Hundreds of Millions More to Share

The US plans to purchase and donate 500 million additional SARS-CoV-2 vaccine doses, according to the Washington Post.

Nature Papers Examine Molecular Program Differences Influencing Neural Cells, Population History of Polynesia

In Nature this week: changes in molecular program during embryonic development leads to different neural cell types, and more.