NEW YORK – Helix said on Monday that the US Food and Drug Administration has granted Emergency Use Authorization for the firm's next-generation sequencing-based COVID-19 test.
Helix's in vitro diagnostic assay is designed to detect the SARS-CoV-2 spike protein gene (and an internal human control, RPP30) in upper respiratory specimens including nasopharyngeal swabs, oropharyngeal swabs, mid-turbinate nasal swabs, and anterior nasal swabs.
The EUA specifies that the test will be performed on the Illumina NovaSeq 6000 instrument using the Xp workflow and must be performed at Helix's San Diego-based CLIA-certified lab. The assay uses nucleic acid isolation and amplification kits from Thermo Fisher Scientific and custom primers from Integrated DNA Technologies. The EUA allows for liquid handling with the Hamilton Microlab Star instrument and the STP Labtech Mosquito HV.
"This test will enable Helix to scale rapidly to 100,000 tests per day while maintaining next-day turnaround time and high sensitivity — ultimately making it one of the country’s highest-throughput COVID-19 labs," a company spokesperson said in an email. The firm expects to launch the test in the fall as part of an end-to-end system that includes sample collection and delivery of results.
Last month, Helix received EUA for a PCR-based COVID-19 test.
Illumina has already received EUA for its own NGS-based test run on the NovaSeq platform. Fulgent Genetics and Clear Labs have also submitted EUA applications for their NGS-based COVID-19 tests.
Helix has partnered with San Diego County to provide as many as 2,000 molecular tests per day.
On July 31, Helix was selected as one of seven companies to receive funding from the National Institutes of Health to address COVID-19 diagnostics. NIH awarded the firm $33.4 million and expects it to process up to 100,000 samples per day by the end of the year.