Skip to main content
Premium Trial:

Request an Annual Quote

FDA Issues First EUA for Non-Prescription COVID-19/Flu/RSV Test

NEW YORK – On Monday, The US Food and Drug Administration issued an Emergency Use Authorization to Laboratory Corporation of America's Seasonal Respiratory Virus RT-PCR DTC test for use without a prescription by individuals with symptoms of COVID-19.

The test can detect and differentiate between SARS-CoV-2, influenza A and B, and respiratory syncytial virus and is the first multianalyte direct-to-consumer test authorized by the FDA.

Users self-collect nasal swab samples and then send those samples to Labcorp for testing. The sample kit can be purchased online or in a store without a prescription.

"While the FDA has now authorized many COVID-19 tests without a prescription, this is the first test authorized for flu and RSV, along with COVID-19, where an individual can self-identify their need for a test, order it, collect their sample, and send it to the lab for testing, without consulting a health care professional," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home."

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.