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Thermo Fisher Scientific, Access Bio, LumiraDx Get FDA EUAs for SARS-CoV-2 Tests

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for a molecular SARS-CoV-2 test from Thermo Fisher Scientific, an antigen test from Access Bio, and a serology test from LumiraDx.

Thermo Fisher's TaqPath COVID-19 MS2 Combo Kit 2.0 is a PCR-based test designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal swabs, mid-turbinate nasal swabs, and anterior nasal swabs. The test may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

Last week, Waltham, Massachusetts-based Thermo Fisher received FDA EUA for its TaqPath COVID-19 Fast PCR Combo Kit 2.0, which tests for SARS-CoV-2 in saliva samples.

Access Bio's CareStart COVID-19 Antigen Home Test is a chromatographic, digital immunoassay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab specimens in individuals with or without symptoms when tested twice over two or three days with at least 24 hours and not more than 48 hours between tests.

The nonprescription test may be self-administered at home and provides results within 10 minutes.

In June, Somerset, New Jersey-based Access Bio received EUA from the FDA for a point-of-care SARS-CoV-2 antibody assay.

The LumiraDx SARS-CoV-2 Ab Test is designed to detect total antibodies against SARS-CoV-2 in serum, plasma, or fingerstick or venous whole blood. For serum, plasma, and venous whole-blood testing, it may be used by any lab CLIA-certified to perform moderate- or high-complexity tests.

Testing of fingerstick whole-blood samples may be performed by labs CLIA-certified to perform high-, moderate-, or waived-complexity tests, or at point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Last month, London-based LumiraDx received FDA EUA for a PCR-based SARS-CoV-2 test.

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