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Helix COVID-19 NGS Test One of the First Sequencing-Based COVID-19 Tests To Secure FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 11 Aug 2020
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Helix (San Mateo, CA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the Helix COVID-19 NGS Test, making it one of the first sequencing-based COVID-19 tests to be granted FDA EUA.

The test is an amplicon-based next-generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider. This test is highly multiplexed to enable a large number of samples to be sequenced on each instrument and is a critical part of Helix's plan to scale its COVID-19 capacity to 100,000 tests per day and potentially further. 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, which has also obtained EUA from the FDA.

"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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