Eurofins’ Clinical Enterprise gains EUA for at-home COVID-19 test kit
Category: #health  By Pankaj Singh  Date: 2021-03-02
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Eurofins’ Clinical Enterprise gains EUA for at-home COVID-19 test kit

Eurofins, a testing laboratories company, has reportedly announced that Clinical Enterprise, Inc. has obtained the EUA (Emergency Use Authorization) from the U.S. FDA. This EUA has been received for a DTC (direct-to-customer) version of the EmpowerDX at-home COVID-19 nasal PCR test kit.

This Eurofins COVID-19 test kit is among the 1st over-the-counter, at-home test kits to have received EUA for use against SARS-CoV-2. Following this authorization, the company will be able to directly market the test kit to consumers without prescription. Currently, the product is available through empowerDX, Eurofins’ subsidiary, and can be purchased online at $99. It has also been made available in pharmacies in the U.S.

The test kit includes a shallow nasal swab, step-by-step instructions, test tube, as well as prepaid FedEx package to ensure easy return of the samples. Customers are expected to obtain their test results through a secure patient portal in 48 hours.

Eurofins Viracor, an infectious disease testing laboratory, has developed the test, which is based on its SARS-CoV-2 RT-PCR assay authorized by the FDA’s EUA. This assay has been ranked as one of the most sensitive tests examined by the FDA SARS-CoV-2 Reference Panel.

According to Gilles Martin, CEO of Eurofins, the company’s test kit will play a major role in increasing the rate of COVID-19 testing among the population. In addition, it is closely collaborating with the European authorities to gain approval for similar other direct-to-consumer products.

Despite being authorized by the U.S. FDA under the EUA for at-home collection & maintenance of the nasal swab specimens to effectively detect nucleic acid from the SARS-CoV-2, the Eurofins COVID-19 test kit has not been fully approved by the FDA. The product must not be used for testing other pathogens or viruses but only for the declaration period of circumstances justifying the EUA of the medical devices under Section 564 of the Federal FD&C (Food, Drug & Cosmetic) Act, 21 U.S.C. § 360bbb-3(b)(1), until and unless the declaration has been terminated or authorization has been revoked.

Source credit:

https://www.businesswire.com/news/home/20210228005064/en/Eurofins-Announces-the-launch-of-an-At-Home-COVID-19-PCR-Test-kit-available-direct-to-consumers-without-prescription



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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