First EUA In US For OTC Test To Detect COVID-19, Flu, RSV Granted To Labcorp
Executive Summary
Agency issued an emergency use authorization to Labcorp for its OTC that detects COVID-19, flu and respiratory syncytial virus.
The US Food and Drug Administration has granted an emergency use authorization to Laboratory Corporation of America (Labcorp) for its Seasonal Respiratory Virus RT-PCR DTC test for people with COVID-19 symptoms. It can be purchased OTC online or in stores.
Labcorp’s test which received an EUA on 16 May is the first direct-to-consumer diagnostic the FDA has authorized that allows for the collection of at-home nasal swabs that can identify and differentiate multiple viruses, including COVID-19, flu and respiratory syncytial virus (RSV), a common infection of the lungs.
“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," said Jeff Shuren, director of the agency’s device center, said in a 16 May announcement of the EUA.
The test's labeling usage instructions state samples can be self-collected by consumers 18 and older and by adolescents 14 to 17 with adult supervision, but should be collected by adults for children under 14.
Test results are delivered via an online portal with follow-up from a health care provider.
The FDA cautions, however, that the test is not intended to be a substitute for visits to a health care provider and that those taking the test should not use the results to “start, stop or change” any course of treatment unless advised to do so from a health care professional.
This article was reported and initially published by Informa Pharma Intelligence's Medtech Insight newsletter.