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FDA Grants EUAs for SARS-CoV-2 Tests, Kits From Exact Sciences, BioGx, Bio-Rad, Everlywell

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorization for molecular SARS-CoV-2 tests from Exact Sciences and BioGx, an immunoassay for detecting the virus from Bio-Rad Laboratories, and an at-home specimen collection kit from Everlywell.

Exact's COVID-Flu Multiplex Assay is designed for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B in anterior nasal swabs self-collected in a healthcare setting.

The RT-PCR-based test may also be used with anterior nasal swab specimens self-collected at home using the Exact Sciences Nasal Swab Home Collection Kit or the newly authorized Everlywell COVID-19 & Flu Test Home Collection Kit.

Exact's test may be performed only at the Madison, Wisconsin-based company's CLIA lab, according to the FDA. Everlywell's collection kit is only for use by CLIA labs designed by Everlywell.

The BioGx Xfree COVID-19 Direct RT-PCR assay is designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate, or nasal aspirates collected by a healthcare provider.

According to Birmingham, Alabama-based BioGx, patient samples can be added directly to a vial containing all RT-PCR reagents without the need for preprocessing or nucleic acid extraction.

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

Bio-Rad's BioPlex 2200 SARS-CoV-2 IgG is designed for the qualitative and semi-quantitative detection of immunoglobulin G against SARS-CoV-2 in serum and plasma. The automated assay, which runs on the Hercules, California-based firm's BioPlex 2200 system, may be used by any lab CLIA-certified to perform moderate- or high-complexity tests.

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