Nanōmix has obtained CE mark for its Covid-19 rapid point-of-care (POC) antigen panel, which is used with the company’s eLab analyser.
The eLab Covid-19 antigen test cartridge provides results in 15 minutes using an anterior nasal swab.
It enables qualitative detection of the SARS-CoV-2 virus nucleocapsid antigen from the swabs.
Nanōmix chief commercial officer John Hardesky said: “Receiving the CE mark for our Covid-19 rapid antigen test is a key milestone, which further validates our rapid and accurate POC testing technology.
“This assay complements our S1 Critical Infection Panel which provides valuable insight to clinicians as they diagnose and monitor severe, co-infections, including those of Covid-19 patients.”
A swab and sample collection tube included with the panel are used to collect nasal swab samples, which are then transferred to the single-use, microfluidic cartridge.
This cartridge is run on the Nanōmix eLab, which can print or send results electronically through Bluetooth.
The eLab system can also publish the test results output as a QR code, providing increased privacy.
Nanōmix president and CEO David Ludvigson said: “The Nanōmix eLab is a comprehensive diagnostic platform that has enormous potential in time-sensitive diagnostic applications.”
Federal funds from the Department of Health and Human Services, the Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority were used to fund the project in whole or in part.
Last February, Nanōmix submitted an Emergency Use Authorization request to the US Food and Drug Administration (FDA) for the portable, handheld eLab Covid-19 rapid antigen test.