Eurofins U.S. Clinical Diagnostics issued the following announcement on Dec. 7.
Eurofins announces that its FDA-authorized At-Home COVID-19 Nasal PCR Test is now being covered by Medicare, Medicaid and commercial insurance providers. The Emergency Use Authorization ("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 link within 24 hours of sample receipt.
Available through the Eurofins at-home health testing company, Clinical Enterprise Inc., through its empowerDX business line, the At-Home test can be ordered online (https://empowerdxlab.com/) and will ship to your home or business. After completing a questionnaire, qualified consumers will receive the sample collection kit via FedEx. Patients who are enrolled in Medicare, Medicaid, or other valid third-party health insurance and meet qualifying COVID-19 exposure and symptomatic criteria, may be eligible for full coverage with no out of pocket costs. EmpowerDX allows patients to input their insurance information online for a seamless ordering and payment experience, or they can alternatively choose the $99.00 out-of-pocket option.
Eurofins' infectious disease center for excellence, Viracor, developed the test based on its highly sensitive, FDA EUA-authorized SARS-CoV-2 RT-PCR assay. Viracor's SARS-CoV-2 assay offers the best sensitivity of the 118 laboratories that have submitted results to FDA's SARS-CoV-2 Reference Panel, with a limit of detection of 180 NAAT Detectable Units/mL1.
The Eurofins U.S. 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, alongside pooled, antibody, wastewater, used-mask, saliva and combined COVID-19, Influenza and RSV tests.
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 diagnostic testing capacity has ramped up to over 500,000 samples per week. Recent turnaround time for results has averaged less than 18 hours from specimen receipt in the lab.
This home-collection kit has not been FDA cleared or approved; rather it has been authorized by FDA under an EUA only for the self-collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens, and only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in medical devices during the COVID-19 outbreak under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The At-Home COVID-19 Nasal PCR Test is currently not available for those patients residing in the States of New York, New Jersey, Rhode Island, and Maryland.
Original source can be found here.
