Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants Emergency Use Authorizations for Quadrant Biosciences, KimForest Coronavirus Tests

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Quadrant Biosciences and KimForest Enterprise.

Quadrant's Clarifi COVID-19 Test Kit is designed to detect two sequences of the SARS-CoV-2 RdRp gene in saliva swab specimens collected by a healthcare provider using DNA Genotek's ORACollect RNA kit.

Nucleic acid extraction is performed using Zymo Research's Quick-RNA Viral 96 Kit and the test runs on either Bio-Rad Laboratories' CFX96 or CFX384 Touch RT-PCR Detection Systems or Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 RT-PCR System, according to Syracuse, New York-based Quadrant.

Gene On Link's KimForest SARS-CoV-2 Detection Kit v1 is designed to detect the RdRp gene of the virus in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasopharyngeal washes, nasopharyngeal or nasal aspirates, and bronchoalveolar lavage specimens collected by a healthcare provider.

The test uses Qiagen's QIAamp Viral RNA Mini Kit for nucleic acid purification and runs on Thermo Fisher's Applied Biosystems StepOne or StepOnePlus RT-PCR Systems, according to New Taipei City, Taiwan-based KimForest. It is distributed in the US by Diamond Bar, California-based Arbelos Genomics.

Both tests may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

The Scan

Sick Newborns Selected for WGS With Automated Pipeline

Researchers successfully prioritized infants with potential Mendelian conditions for whole-genome sequencing or rapid whole-genome sequencing, as they report in Genome Medicine.

Acne-Linked Loci Found Through GWAS Meta-Analysis

Researchers in the European Journal of Human Genetics find new and known acne vulgaris risk loci with a genome-wide association study and meta-analysis, highlighting hair follicle- and metabolic disease-related genes.

Retina Cell Loss Reversed by Prime Editing in Mouse Model of Retinitis Pigmentosa

A team from China turns to prime editing to correct a retinitis pigmentosa-causing mutation in the PDE6b gene in a mouse model of the progressive photoreceptor loss condition in the Journal of Experimental Medicine.

CRISPR Screens Reveal Heart Attack-Linked Gene

Researchers in PLOS Genetics have used CRISPR screens to home in on variants associated with coronary artery disease that affect vascular endothelial function.