Research & Development
Eurofins US Clinical Diagnostics Network Receives EUA Approval of At Home COVID-19 Test
19 October 2020 - - Luxembourg-based laboratory group Eurofins Scientific's Eurofins US Clinical Diagnostics' Clinical Enterprise Inc. has received an Emergency Use Authorization (EUA) from the US Food and Drug Administration for their at Home COVID-19 Nasal PCR Test, the group said.

The EUA authorized self-collection kit gives consumers a minimally invasive, convenient and quick option to test from the comfort of their home. Results are provided via email within 24 hours of sample receipt.

Available through the Eurofins direct-to-consumer company, empowerDX, the at home test can be ordered online for USD 89.

After completing a questionnaire, consumers will receive the sample collection kit via FedEx.

Eurofins' infectious disease centre for excellence, Viracor, developed the test based on its highly sensitive, FDA EUA-authorized SARS-CoV-2 RT-PCR assay.

The Eurofins US Clinical Diagnostics network has been at the forefront of COVID-19 testing launching its first RT-PCR assay for SARS-CoV-2 on March 13.

Since then, Eurofins has rolled out several highly sensitive and specific assays to thousands of clients nationwide, including hospitals, physicians' offices, nursing homes, government entities, sports organizations and employers.

At-home COVID-19 testing adds additional capability to an already robust menu including pooled testing, antibody testing, wastewater, used-mask, and soon to be launched saliva testing.

Concurrent to ongoing COVID-19 assay innovation, Eurofins has increased capacity throughout its network of labs to ensure sufficient capacity is available for consistency of turnaround time should COVID-19 infections continue to increase in the upcoming weeks.

Since March, Eurofins US Clinical Diagnostics testing capacity has ramped up to over 500,000 samples per week. The turnaround time for results has averaged less than18 hours from receipt in the lab.

The at Home COVID-19 Nasal PCR Test is currently not available in New York, New Jersey, Rhode Island, and Maryland.
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