Skip to main content
Premium Trial:

Request an Annual Quote

Helix Diagnostics SARS-CoV-2 Test Nabs FDA EUA for Serial Testing

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.

The Scan

Cell Signaling Pathway Identified as Metastasis Suppressor

A new study in Nature homes in on the STING pathway as a suppressor of metastasis in a mouse model of lung cancer.

Using Bees to Gain Insights into Urban Microbiomes

As bees buzz around, they pick up debris that provides insight into the metagenome of their surroundings, researchers report in Environmental Microbiome.

Age, Genetic Risk Tied to Blood Lipid Changes in New Study

A study appearing in JAMA Network Open suggests strategies to address high lipid levels should focus on individuals with high genetic risk and at specific ages.

Study Examines Insights Gained by Adjunct Trio RNA Sequencing in Complex Pediatric Disease Cases

Researchers in AJHG explore the diagnostic utility of adding parent-child RNA-seq to genome sequencing in dozens of families with complex, undiagnosed genetic disease.