Eurofins U.S. Clinical Diagnostics Network Receives EUA Approval of At Home COVID-19 Test

Nachrichtenquelle: Business Wire (engl.)
19.10.2020, 07:00  |  157   |   |   

Regulatory News:

Eurofins U.S. Clinical Diagnostics (Paris:ERF), announced that Clinical Enterprise Inc. has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their At Home COVID-19 Nasal PCR Test. 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 reviewed by a licensed physician and provided via email within 24 hours of sample receipt.

Available through the Eurofins direct-to-consumer company, empowerDX, the at home test can be easily ordered online (https://empowerdxlab.com/) for $89. After completing a simple online questionnaire, consumers will receive the sample collection kit via FedEx. The user-friendly kit includes a small nasal swab, collection tube, easy to follow step-by-step instructions and a pre-paid, pre-addressed FedEx package. The nasal swabs for the empowerDX at Home COVID-19 Test are a less invasive alternative than more common nasal pharyngeal swabbing techniques.

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 U.S. Clinical Diagnostics network has been at the forefront of COVID-19 testing – launching its first RT-PCR (real-time reverse-transcriptase polymerase chain reaction) assay for SARS-CoV-2 on March 13. Since then, Eurofins has rolled out several highly sensitive and specific, active infection and antibody assays to thousands of clients nationwide, including hospitals, physicians’ offices, nursing homes, government entities, sports organizations and employers. At-home COVID-19 testing adds an additional capability to an already robust group of assays 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 to ensure 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 than 18 hours from receipt in the lab.

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Eurofins U.S. Clinical Diagnostics Network Receives EUA Approval of At Home COVID-19 Test Regulatory News: Eurofins U.S. Clinical Diagnostics (Paris:ERF), announced that Clinical Enterprise Inc. has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their At Home COVID-19 Nasal PCR Test. …

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