Nanomix has resubmitted an application to the US Food and Drug Administration (FDA) seeking emergency use authorization (EUA) for its eLab COVID-19 rapid antigen test.
The latest move follows the submission of an application for EUA to the FDA for the same product in February.
The new application from Nanomix includes clinical development documentation as well as additional analytical data in response to review comments from the FDA.
The portable, handheld eLab COVID-19 rapid antigen test, which runs on the portable Nanomix eLab analyser, delivers results within 15 minutes.
It delivers laboratory-quality results in any setting to help expand the access and availability of testing for Covid-19.
The assay uses nasal swab samples and detects nucleocapsid antigens from SARS-CoV-2.
A swab and nasal sample collection tube are used to collect samples from the user and transferred to the single-use, microfluidic cartridge.
The cartridge can print or deliver results electronically through Bluetooth.
The point-of-care antigen system can also publish the test results as a QR code for privacy.
Nanomix president and CEO David Ludvigson said: “We look forward to the FDA’s review of our application and are proud of the work our team has done to develop a rapid, portable Covid-19 antigen test during this critical time.
“If authorised by the FDA, we believe our mobile point-of-care system will greatly increase accessibility to Covid-19 testing.”
The company stated that the development project secured federal funds, either in whole or in part, from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response , and Biomedical Advanced Research and Development Authority (BARDA) Division of Research Innovation and Ventures.