Pioneering Nanopore Sequencing-Based COVID Diagnostic Bags Emergency Use Approval

By Rajaneesh K. Gopinath, Ph.D.

Menlo Park, California-based Next-Generation Sequencing (NGS) company, Clear Labs, announced that its descriptive, diagnostic SARS-CoV-2 test (Clear Dx™ SARS-CoV-2) obtained the FDA’s emergency use authorization (EUA), becoming the world’s first FDA-approved use of nanopore sequencing SARS-CoV-2 detection technology.

Clear Dx’s detection method involves extracting RNA from a swab sample, then amplify the target and use the Oxford Nanopore GridION gene sequencer developed by Oxford Nanopore Technologies for nanopore gene sequencing to analyze the results. The test is a fully automated NGS, often used for infection diagnosis and disease mutation monitoring.

Clear Dx can simultaneously diagnose a high volume of SARS-CoV-2 and achieve an in-depth analysis of the virus, mainly to track potential mutants that are resistant, highly pathogenic, or difficult to be detected by PCR. The following data could provide crucial information on how to design future treatments for COVID-19. Besides, Clear Dx detection is more accurate than quantitative real-time polymerase chain reaction (qPCR) and can provide data results within a few hours, optimizing detection time efficiency.

“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.”

In May 2020, Clear Labs raised US$ 18 million to commercialize its food safety platform and to also reappropriate its NGS technology for the clinical market that includes COVID-19 diagnostic tests. Clear Labs’ NGS technology can provide high-precision SARS-CoV-2 virus detection. This can help hospitals and biotech industries in the developing treatment methods to respond to the evolution of RNA viruses in real-time, thereby effectively suppressing the spread and mutation of the virus.

Clear Labs is the only company in the world with an automated and intelligent diagnostic next-generation gene sequencing platform. It uses gene sequencing, bioinformatics, and mechanized instruments to solve common testing challenges, such as high false-negative rates and binary results that cannot differentiate RNA viruses and their subtypes.

Related Article: Scientists Further Powerful Gene Editing Tech’s Caliber with Rapid, Low Cost COVID-19 Diagnosis

References

1. https://www.fda.gov/media/142419/download
2. https://www.prweb.com/releases/clear_labs_granted_eua_by_fda_for_sars_cov_2_novel_descriptive_diagnostic/prweb17421553.htm

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Author

Rajaneesh K. Gopinath