US FDA Grants Emergency Use Authorization For ViraDx™
11 September 2023
Lumos Diagnostics (ASX: LDX) had today announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) for Lumos’ combined COVID-19/Flu A/Flu B rapid POC test, ViraDx™.
ViraDx is a rapid point-of-care 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 now been authorised for use by healthcare professionals in the US including for use at any healthcare site operating under a CLIA Certificate of Waiver.
In the 2022-23 influenza season (October-April), the Center for Disease Control (CDC) estimated that between 12 – 26 million Americans visited their doctor with flu symptoms.
Lumos 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.
CEO and MD of Lumos Diagnostics, Doug Ward, commented:
“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. 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.”
Click here to read the announcement
ViraDx is a rapid point-of-care 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 now been authorised for use by healthcare professionals in the US including for use at any healthcare site operating under a CLIA Certificate of Waiver.
In the 2022-23 influenza season (October-April), the Center for Disease Control (CDC) estimated that between 12 – 26 million Americans visited their doctor with flu symptoms.
Lumos 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.
CEO and MD of Lumos Diagnostics, Doug Ward, commented:
“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. 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.”
Click here to read the announcement
