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FDA Issues EUAs for Gravity Diagnostics Coronavirus Test, Sample Self-Collection Kit from RapidRona

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test from Gravity Diagnostics and a sample self-collection kit from RapidRona.

The FDA also said it has reissued EUAs for SARS-CoV-2 tests developed by Roche and Express Gene to reflect their authorized use with additional sample types.

The Gravity Diagnostics SARS-CoV-2 RT-PCR assay is designed to detect the N, ORF1ab, and S genes of the virus in nasal, nasopharyngeal, and oropharyngeal swab specimens collected by healthcare providers from both symptomatic and asymptomatic individuals. It may also be used with nasal swab specimens self-collected using either the Everlywell COVID-19 Test Home Collection Kit or the Kroger Health COVID-19 Test Home Collection Kit, and with saliva specimens collected in a healthcare setting using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.

The test uses Thermo Fisher Scientific's KingFisher Flex instrument and Hamilton's Microlab STAR system for nucleic acid isolation. It runs on Thermo Fisher's Applied Biosystems QuantStudio 12k Flex and QuantStudio 7 instruments. The test may be performed only by Gravity.

In June, the Covington, Kentucky-based company received FDA EUA for its COVID-19 Assay.

The RapidRona Self-Collection Kit is designed for the at-home collection of nasal swab specimens. Specimens are sent to authorized labs designated by the Chicago-based company for molecular testing, according to the FDA.

"We offer CLIA-certified laboratories the opportunity to participate in the US testing effort as their capacity ebbs and flows," RapidRona Cofounder and CEO Heather Mlodinow said in a statement. "That flexibility to match lab supply with patient demand in real-time is what enables RapidRona to consistently deliver test results within 48 business hours of taking the sample."

Roche received a reissued EUA for its Cobas SARS-CoV-2 test, which was originally authorized in March for the detection of SARS-CoV-2 nucleic acid in in nasopharyngeal and oropharyngeal swab samples from patients who meet the clinical and epidemiological criteria for testing. 

Under the reissued EUA, the RT-PCR-based test may now be used with pooled samples containing up to six individual samples, including self-collected nasal swab specimens collected in a healthcare setting and clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens.

Express Gene received a reissued EUA for its 2019-nCoV RT-PCR Diagnostic Panel, which was first authorized in May for the detection of the SARS-CoV-2 ORF1ab, N, and S genes in respiratory tract specimens such as nasopharyngeal swabs and bronchoalveolar lavage. 

Under the reissued EUA, the Palmetto Bay, Florida-based company's test may also be used with saliva samples collected in a healthcare setting using the mLife True Oral Fluid/Viral Collection Kit.

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