NEW YORK – Helix Diagnostics has received Emergency Use Authorization from the US Food and Drug Administration for its multiplex SARS-CoV-2 test for serial testing, the FDA said on Monday.
The Helix Diagnostics SARS nCoV-2019 Multiplexed Assay is a laboratory-developed test and is only authorized for use at the company's laboratory in Waterford, Michigan. The RT-PCR test detects SARS-CoV-2 RNA from anterior nasal swab samples that have either been collected by a healthcare provider or self-collected under the supervision of a healthcare provider when tested at least once per week, according to the EUA document.
The FDA noted that the clinical performance of the test may vary depending on the circulating variants, including newly emerging strains of the virus, and their prevalence. It added that a study to determine the clinical performance of the test in people without symptoms or other reasons to suspect COVID-19 will be completed.
The test received EUA under the umbrella EUA for serial testing, which allows authorized tests to be used with individual or pooled specimens to test people at least once per week regardless of symptoms or exposure to COVID-19, such as in serial testing programs implemented by schools or workplaces.
Helix Diagnostics is not related to Helix, which also has multiple COVID-19 tests that have received FDA EUA.