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FDA Grants Emergency Use Authorizations for SARS-CoV-2 Tests From Harvard, NowDiagnostics

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for a molecular SARS-CoV-2 test developed by Harvard University and a point-of-care immunoassay for the virus from NowDiagnostics.

Harvard's Quaeris SARS-CoV-2 Assay is designed to detect the virus's N and RdRP genes in anterior nasal swab specimens either self-collected or healthcare provider-collected using the COVID-19 Self-Swab Collection Kit for Harvard University Clinical Laboratory.

The test does not require nucleic acid extraction and runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 7 RT-PCR instrument. It may only be performed by the Harvard University Clinical Laboratory in Cambridge, Massachusetts.

NowDiagnostics' AdexusDx COVID-19 Test is a lateral flow immunoassay designed to detect total antibodies against SARS-CoV-2 in whole blood, plasma, and serum when used by laboratories CLIA-certified to perform moderate- or high-complexity tests.

The assay may also be used with fingerstick blood samples by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests, and at the point of care in settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

According to Springdale, Arkansas-based NowDiagnostics, the test provides results within 15 minutes and will be offered in CLIA-waived settings such as pharmacies, clinics, and hospital emergency departments.

The test, which received CE marking in mid-2020, was developed with $695,500 in funding from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

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