NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a SARS-CoV-2 molecular test developed by Helix.
The test is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected without supervision using the Helix COVID-19 Self-Collection Kit by individuals 18 or older who are suspected of having COVID-19 by a healthcare provider.
Testing is limited to Helix's CLIA-certified laboratories in San Diego, the FDA said.
SARS-CoV-2 nucleic acid is first extracted, isolated, and purified from anterior nasal swab specimens, and then the purified nucleic acid is reverse transcribed into cDNA followed by PCR amplification and detection using an authorized RT-PCR instrument.
The Helix COVID-19 Self-Collection Kit provides specimen collection and storage materials as well as materials for the user to drop off the sample at a designated location for shipment to the testing laboratory.
In July 2020, San Mateo, California-based Helix obtained FDA EUA for its COVID-19 Test that detects the SARS-CoV-2 nucleocapsid, ORF1ab, and spike protein genes in upper respiratory specimens, and in August 2020, it obtained FDA EUA for a next-generation sequencing-based COVID-19 test.