FDA Authorizes First Nanopore Sequencing-Based Test for SARS-CoV-2

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to the Clear Dx SARS-CoV-2 novel descriptive diagnostic from Clear Labs (San Carlos, CA, USA), making it the first nanopore sequencing-based test for SARS-CoV-2 to receive EUA.

Clear Dx offers a fully automated, nanopore-based NGS solution for simultaneous high-volume diagnosis of SARS-CoV-2 and deeper genomic characterization of the virus. At a price comparable to qPCR, Clear Dx simultaneously improves test accuracy while providing end-to-end results in hours, instead of days. The sequencing analysis enables monitoring for mutations that may confer drug resistance, enhance virulence, and cause loss of diagnostic targets for PCR. Data from the platform will also help advance emerging pharmaceutical interventions which are intended to target COVID-19.

Clear Labs’ proprietary NGS platform leverages the latest technology in automation, molecular testing, machine learning and a proprietary bioinformatics pipeline. Visualized with intuitive software reporting and data analysis, the flexible architecture has allowed the company to quickly develop a turn-key genomics assay to provide more accurate COVID-19 testing. Based on technology which has revolutionized the food safety testing market, the company’s novel descriptive diagnostic addresses current testing limitations, including high false negative rates and binary results that cannot differentiate RNA viruses and subtypes.

“We’re encouraged by the rapid response of the testing market to stop the global spread of COVID-19, and knew that our technology is serving an unmet need,” said Sasan Amini, CEO of Clear Labs. “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.”

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