Lumos Diagnostics receives FDA EUA for ViraDx Rapid POC Test

Lumos Diagnostics (ASX: LDX) has announced that its ViraDx test has been granted Emergency Use Authorization (EUA) and a CLIA Waiver by the US Food and Drug Administration (FDA). The rapid Point-of-Care (POC) test can simultaneously detect COVID-19, influenza A, and influenza B viruses and provides results within 15 minutes. The test received Health Canada’s Interim Order Authorization in June 2022.

The ViraDx test uses either nasal or nasopharyngeal swab samples and yields qualitative results that are easy to read and interpret without additional instruments. It has been authorized for use by healthcare professionals in the United States, including those operating under a CLIA Certificate of Waiver. This authorization means the test poses insignificant risk for incorrect results. As part of the EUA, the FDA has also requested some post-marketing studies, which may require future investments.

Lumos plans to offer ViraDx through its newly established U.S. sales channel aimed at Point-of-Care products for women’s health, STIs, and infectious diseases. This inclusion expands the sales channel’s product menu, which will later feature Lumos’ FebriDx product as well. Considering the fluctuating market demand for rapid antigen tests (RATs) for COVID-19, Lumos will adjust its sales and marketing investment for ViraDx based on end-user demand.

Doug Ward, CEO and Managing Director of Lumos Diagnostics, said, “We are delighted to be granted Emergency Use Authorization to market the three-in-one ViraDx test for acute viral respiratory infections in the US. This is an important addition to the suite of products that we will offer healthcare professionals through our recently established U.S. 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 U.S. regulatory registrations for Lumos’ point-of-care products within the last three months.”