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FDA Grants EUAs for Direct-to-Consumer Coronavirus Sample Collection Kit, Two Molecular Tests

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorizations allowing for the direct-to-consumer sale of Everlywell's at-home nasal swab collection kit, as well as molecular SARS-CoV-2 tests developed by Gravity Diagnostics and Assurance Scientific Laboratories.

The Everlywell COVID-19 Test Home Collection Kit DTC comprises sample registration instructions, sample collection instructions, sample preparation and shipping instructions, a nasal swab, saline in a tube, shipping materials, and return labels.

The kit was first authorized by the FDA in May for distribution only to individuals who meet inclusion criteria based on information provided through an online questionnaire and reviewed by the Physician Wellness Network. With the latest EUA, the kit may also be purchased over the counter by adults without COVID-19 symptoms or suspected exposure to SARS-CoV-2, according to the Austin, Texas-based company.

The Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits is designed to detect the N, ORF1ab, and S genes of the virus in anterior nasal swab specimens self-collected using Everlywell's DTC collection kit or Kroger Health's authorized COVID-19 Test Home Collection Kit. It runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 12K Flex or QuantStudio 7 instruments and may performed only at Gravity's CLIA-certified lab.

In November, Covington, Kentucky-based Gravity received FDA EUA for a version of the assay that uses nasal, nasopharyngeal, and oropharyngeal swab specimens collected by healthcare providers. 

Assurance Scientific's Assurance SARS-CoV-2 Panel DTC is designed to detect the virus's N gene in anterior nasal swab specimens self-collected using its Simplicity COVID-19 Home Collection Kit or Everlywell's DTC kit. It runs on Bio-Rad Laboratories' CFX96 or CFX384 instruments and may be used only by CLIA-certified labs designated by Assurance Scientific.

In mid-2020, Birmingham, Alabama-based Assurance Scientific received FDA EUA for a SARS-CoV-2 panel that detects the virus E gene in nasal, nasopharyngeal, or oropharyngeal swabs.

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