Lumos Diagnostics (ASX:LDX) has announced that the US FDA has granted Emergency Use Authorisation (EUA) and a CLIA Waiver (Clinical Laboratory Improvement Amendments) for the ViraDx test, which is a combined COVID-19/Flu A/Flu B rapid POC test.
ViraDx is a rapid point-of-care (POC) test that simultaneously tests for acute respiratory infections caused by the COVID-19, influenza A, and influenza B viruses.
The test uses nasal or nasopharyngeal swab samples and provides a result within 15 minutes.
ViraDx has been authorised for use by healthcare professionals in the US, including for use at any healthcare site operating under a CLIA Certificate of Waiver, which means it is of insignificant risk for an incorrect result.
The company said that, as part of the EUA, the FDA has requested some post-marketing studies that may require additional investment.
Lumos said it intends to offer ViraDx to healthcare providers in the US through its recently established sales channel for POC products for women’s health, STI’s and infectious diseases.
“We are delighted to be granted Emergency Use Authorisation to market the three-in-one ViraDx test for acute viral respiratory infections in the US,” said Doug Ward, CEO and managing director of Lumos. “This is an important addition to the suite of products that we will offer healthcare professionals through our recently established US sales channel. It is also a credit to the expertise and capabilities of Lumos’ clinical and regulatory teams that they have managed to secure two US regulatory registrations for Lumos’ point-of-care products within the last three months.”