NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for molecular SARS-CoV-2 tests from PathogenDx and Southern California Permanente Medical Group, or SCPMG, as well as a serological test for antibodies against the virus from Inova Diagnostics.
PathogenDx's DetectX-Rv is a real-time PCR and DNA microarray hybridization test designed to detect the SARS-CoV-2 N gene in nasopharyngeal, oropharyngeal, midturbinate, and anterior nasal swabs, as well as nasal aspirates, nasopharyngeal wash/aspirates, and bronchoalveolar lavage, collected by a healthcare provider.
The assay uses Thermo Fisher Scientific's Applied Biosystems MiniAmp thermocycler, Sensovation's Sensospot microarray scanner, and PathogenDx's Augury analysis software. It may be performed only by labs CLIA certified to perform high-complexity tests, according to the FDA.
Earlier this month, Scottsdale, Arizona-based PathogenDx won a contract from the US National Institutes of Health to develop a high-throughput test targeting multiple genetic sites to detect and identify SARS-CoV-2 variants.
SCPMG's Kaiser Permanente High Throughput SARS-CoV-2 Assay leverages RT-PCR technology and is designed to detect the N, S, and ORF1b genes of the virus in saliva samples self-collected using Spectrum Solutions' FDA-authorized SDNA-1000 Saliva Collection Device. It runs on Thermo Fisher's Amplitude Solution, a modular system for high-throughput SARS-CoV-2 testing that recently received FDA EUA.
The test may only be performed by Chino Hills, California-based SCPMG's regional reference lab, according to the FDA.
Inova's Quanta Flash SARS-CoV-2 IgG is a chemiluminescent immunoassay designed to detect immunoglobulin G against the virus in serum and plasma using the San Diego-based company's Bio-Flash analyzer.
It may be used by any lab CLIA certified to perform moderate- or high-complexity tests, the FDA said.