NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a GetMyDNA's nasal swab specimen self-collection kit, which is used with a PCR-based SARS-CoV-2 test from affiliate Gravity Diagnostics.
The GetMyDNA COVID-19 Test Home Collection Kit is designed for the self-collection of anterior nasal swab specimens and is available without a prescription, according to GetMyDNA. Collected samples are tested using Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits.
Gravity's test kit, which detects the SARS-CoV-2 N, ORF1ab, and S genes, received FDA EUA in February for use with Everlywell's DTC collection kit or Kroger Health's authorized COVID-19 Test Home Collection Kit. This week, that EUA was reissued to include the use of samples collected with the GetMyDNA kit.
Both Gravity and GetMyDNA are based in Covington, Kentucky, and are headed by Cofounder and CEO Tony Remington.