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December 2, 2021

Nanomix resubmits EUA application to FDA for Covid-19 rapid antigen test

The eLab Covid-19 rapid antigen test delivers results within 15 minutes.

Nanomix has resubmitted an application to the US F ood and Drug Administration (F DA) seeking emergency use authorization (EUA) for its eLab COVID-19 rapid antigen test.

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The latest move follows the submission of an application for EUA to the F DA for the same product in F ebruary.

The new application from Nanomix includes clinical development documentation as well as additional analytical data in response to review comments from the F DA.

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 F DA’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 F DA, 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.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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