Population genomics company Helix has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its sequencing-based Covid-19 test.
Helix Covid-19 NGS test, an amplicon-based next-generation sequencing (NGS) test, has been designed for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens from individuals suspected of Covid-19 by their healthcare provider.
The specimens comprise of nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs.
The multiplexed test enables to sequence a large number of samples on each instrument
Helix’s multiplexed test allows to sequence a large number of samples on each instrument, helping to extend the company’s capacity to 100,000 tests per day and further.
Developed based on Octant’s SwabSeq protocol, the Helix Covid-19 NGS test is claimed to be one of the first next-generation sequencing tests authorised by the FDA.
The test is part of the company’s end-to-end test system, which comprises a non-invasive collection kit.
Helix will process the samples at its high-complexity laboratory in San Diego, and provides the results to the ordering healthcare professional with next-day turnaround time.
Helix president and CEO Marc Stapley said: “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.
“Combined with the recent funding we announced from the NIH RADx program, we will quickly become one of the highest throughput Covi-19 testing labs in the country and help millions of Americans access much-needed tests with next-day turnaround time.”
Recently, Siemens Healthineers has secured EUA status from the FDA for its SARS-CoV-2 IgG (COV2G) antibody test.
