FDA Authorizes Sequencing-Based COVID-19 Test


The authorization is for an amplicon-based next-generation sequencing test from Helix.

Helix, a population genomics biotechnology company, has announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 NGS Test.

The test is an amplicon-based next-generation sequencing (NGS) test. It is used for the detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens such as nasopharyngeal swabs, throat swabs, mid-turbinate nasal swabs, and anterior nasal swabs.

The test is multiplexed to enable a high number of samples to be sequenced on each instrument. The company hopes to raise its COVID-19 testing capacity to 100,000 tests per day.

“As one of the first next-generation sequencing tests authorized by the FDA, the Helix COVID-19 NGS Test will enable Helix to diversify and add redundancy to its existing supply chain for its PCR-based test, the Helix COVID-19 Test, also authorized for emergency use by the FDA,” Helix announced.

"The authorization of our next-generation sequencing-based test is an important step forward in dramatically scaling our COVID-19 testing capacity while maintaining high sensitivity," said Marc Stapley, Helix President and CEO.

"Combined with the recent funding we announced from the NIH RADx program, we will quickly become one of the highest throughput COVID-19 testing labs in the country and help millions of Americans access much-needed tests with next-day turnaround time."

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