Helix announced today that it received FDA emergency use authorization (EUA) for its Helix COVID-19 next-generation sequencing (NGS) test.
San Mateo, Calif.-based Helix’s NGS test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 (the virus causing coronavirus) in upper respiratory specimens from individuals suspected of having COVID-19 by their healthcare provider, according to a news release.
The company said its test is highly multiplexed to enable a large number of samples to be sequenced on each instrument as part of its plan to scale its COVID-19 testing capacity to 100,000 tests per day, with eyes on even more down the road.
Helix developed the test on the back of Octant’s “SwabSeq” protocol and is set to diversify the company’s existing supply chain for its PCR-based Helix COVID-19 test which also has EUA. The company was recently selected as part of the National Institutes of Health’s Rapid Acceleration of Diagnostics program which includes a $249 million investment in COVID-19 testing.
“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,” Helix president & CEO Marc Stapley said in the release. “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.”