NEW YORK — The US Food and Drug Administration has reissued an Emergency Use Authorization for Helix's PCR-based SARS-CoV-2 test, allowing its use with self-collected specimens and in asymptomatic individuals for screening or population-based testing, the company said on Monday.
The Helix COVID-19 Test is designed to detect the SARS-CoV-2 nucleocapsid, ORF1ab, and spike protein genes. It first received EUA from the FDA in July for use with upper respiratory specimens collected by healthcare providers from individuals suspected of SARS-CoV-2 infection.
San Mateo, California-based Helix said that this EUA has now been reissued, expanding it to include unsupervised specimen collection in people with or without COVID-19 symptoms.
"Being able to broadly test individuals irrespective of symptoms is critical to ensure we're able to prevent and mitigate outbreaks and identify people as early as possible in the course of infection," Helix Cofounder and President James Lu said in a statement. "Further, reducing the barriers to testing enables us to reach some of the most vulnerable and underserved populations in the US."
In August, Helix received EUA from the FDA for a next-generation sequencing-based SARS-CoV-2 test.