Helix, which specializes in population genomics, announced that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Helix COVID-19 NGS Test, according to a press release from the company.
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 sequencing of a large number of samples on each instrument, the company said.
The FDA EUA is for testing of specimens at the Helix lab in San Diego, which is certified for high-complexity testing. The company said it plans to offer next-day turnaround times on returning test results to the ordering healthcare professional, the patient, and public health agencies, as necessary.
Helix was one of seven biomedical companies that received funding from the National Institutes of Health (NIH) in July to support development of a range of lab-based and point-of-care (POC) tests to detect SARS-CoV-2.
