Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Renewed Gain-of-Function Worries

The New York Times writes that the pandemic is renewing concerns about gain-of-function research.

Who's Getting the Patents?

A trio of researchers has analyzed gender trends in biomedical patents issued between 1976 and 2010 in the US, New Scientist reports.

Other Uses

CBS Sunday Morning looks at how mRNA vaccine technology could be applied beyond SARS-CoV-2.

PLOS Papers Present Analysis of Cervicovaginal Microbiome, Glycosylation in Model Archaea, More

In PLOS this week: functional potential of the cervicovaginal microbiome, glycosylation patterns in model archaea, and more.