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FDA Grants EUAs for Coronavirus At-Home Kit, Tests From Everlywell, Fulgent, Assurance Scientific

NEW YORK — The US Food and Drug Administration on Friday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Fulgent Therapeutics and Assurance Scientific Laboratories, as well as for an at-home nasal swab collection kit from Everlywell that can be used with the two tests.

Fulgent's COVID-19 by RT-PCR test is designed to detect regions in the SARS-CoV-2 nucleocapsid gene, using methods adapted from the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel, in nasal, nasopharyngeal, and oropharyngeal swabs. It can be used with Qiagen's QIAamp Viral RNA Mini Kit or Zymo Research's Quick-RNA Viral Kit RNA Extraction Kits, and runs on Thermo Fisher Scientific's QuantStudio 6 or QuantStudio 7 Real-Time PCR systems.

Assurance's SARS-CoV-2 Panel is designed to detect the SARS-CoV-2 E gene in nasal, nasopharyngeal, or oropharyngeal swabs. Nucleic acid extraction is performed using Zymo QuickRNA Viral Kit RNA Extraction Kit with Abnova's Precipitor 32 or Indical Biosciences' Indimag 48 systems. The test runs on Bio-Rad's CFX384 or CFX96 RT-PCR instruments using CFX Maestro software.

According to the FDA, both tests are limited to use by the CLIA-certified labs of their developers. 

Everlywell's COVID-19 Test Home Collection Kit includes sample registration instructions, sample collection instructions, sample preparation and shipping instructions, a nasal swab, saline in a tube, shipping materials, and return labels. It is only authorized for distribution to individuals who meet inclusion criteria based on information provided through an online questionnaire and reviewed by the Physician Wellness Network.

Fulgent's and Assurance's tests are both authorized for use with Everlywell's nasal swab collection kit.

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