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

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.