Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants EUAs for SARS-CoV-2 Tests From Thermo Fisher Scientific, Phase Scientific International

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test from Thermo Fisher Scientific and a point-of-care antigen test for the virus from Phase Scientific International.

Thermo Fisher's TaqPath COVID-19 Fast PCR Combo Kit 2.0 is designed to detect SARS-CoV-2 nucleic acid in saliva samples collected without preservatives by a healthcare provider. It is authorized for use by any lab CLIA-certified to perform high-complexity tests.

The test, which received CE marking in June, uses eight targets across three genomic regions to ensure accurate detection even with SARS-CoV-2 variants, according to Carlsbad, California-based Thermo Fisher.

Phase's Indicaid COVID-19 Rapid Antigen Test is a lateral flow immunoassay designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from potentially infected individuals within five days of symptom onset. Samples may be collected by a healthcare provider or self-collected under supervision.

According to Hong Kong-based Phase, the test provides results within 20 minutes. It may be used by any lab CLIA-certified to perform moderate-, high-, or waived-complexity tests. It is also authorized for use in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, according to the FDA.

The Scan

Removal Inquiry

The Wall Street Journal reports that US lawmakers are seeking additional information about the request to remove SARS-CoV-2 sequence data from a database run by the National Institutes of Health.

Likely to End in Spring

Free lateral flow testing for SARS-CoV-2 may end in the UK by next spring, the head of Innova Medical Group says, according to the Financial Times.

Searching for More Codes

NPR reports that the US Department of Justice has accused an insurance and a data mining company of fraud.

Genome Biology Papers on GWAS Fine-Mapping Method, COVID-19 Susceptibility, Rheumatoid Arthritis

In Genome Biology this week: integrative fine-mapping approach, analysis of locus linked to COVID-19 susceptibility and severity, and more.