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FDA Grants EUAs for Coronavirus Tests From Clinomics, Princeton BioMeditech, UPenn, Inno Diagnostics

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorizations for a PCR-based SARS-CoV-2 test developed by Clinomics and a combination SARS-CoV-2/influenza point-of-care antigen test from Princeton BioMeditech. In addition, last month it granted EUAs for PCR-based SARS-CoV-2 tests developed by the University of Pennsylvania and Inno Diagnostics Reference Laboratory.

The Clinomics TrioDx RT-PCR COVID-19 Test is designed to detect the RdRp, E, and N genes of SARS-CoV-2 in nasopharyngeal, oropharyngeal, mid-turbinate, and anterior nasal swabs collected by healthcare providers.

Nucleic acid extraction is performed manually using Qiagen's QIAamp Viral RNA Mini Kit or in an automated process with either Promega's Maxwell RSC 48 instrument or Thermo Fisher Scientific's King Fisher Flex system, according to San Diego-based Clinomics. The test runs on Thermo Fisher's Applied Biosystems QuantStudio 6 Flex instrument.

Clinomics' test may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

Princeton BioMeditech's Status COVID-19/Flu test is designed for the qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A, and influenza B using nasopharyngeal swab specimens collected by a healthcare provider. The lateral flow immunochromatographic assay is a modified version of the Monmouth Junction, New Jersey-based company's Status Flu A&B test, which received FDA clearance in 2010.

The test may be used by labs CLIA-certified to perform high-, moderate-, or waived complexity tests, according to the FDA. It may also be used in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The University of Pennsylvania's BD Max COVID-19 Assay is designed to detect the ORF1a gene of SARS-CoV-1 in nasopharyngeal swab specimens. It runs on Becton Dickinson's BD Max Open System and may only be performed at the university, the FDA said.

Inno Diagnostics' test is designed to detect the SARS-CoV-2 N gene in upper respiratory specimens. Nucleic acid extraction is performed using Qiagen's QIAamp Viral RNA kit and the test runs on Roche's LightCycler 480 II instrument. The test may only be performed by Inno Diagnostics, which is part of Puerto Rico-based Ponce Medical School.