Skip to main content
Premium Trial:

Request an Annual Quote

Phosphorus Diagnostics Gets FDA EUA for Direct-to-Consumer Coronavirus Test, Sample Collection Kit

NEW YORK — Phosphorus Diagnostics on Monday received Emergency Use Authorization from the US Food and Drug Administration for a direct-to-consumer version of its saliva-based SARS-CoV-2 assay, as well as for an at-home sample collection kit that can be used with the test.

The Phosphorous COVID-19 RT-qPCR Test DTC is designed to detect the N gene of the virus in saliva samples collected at home, including in a community-based setting. It runs on Bio-Rad Laboratories' CFX384 Touch Real-Time PCR Detection System and may be used only by Phosphorus-designated labs that are CLIA-certified to perform high-complexity tests, according to the FDA.

Samples used with the test are self-collected using the Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC, which also received FDA EUA on Monday. The kit includes a sample collection device, instructions for use, and shipping materials.

The prescription-only version of Phosphorus' DTC test, which uses saliva samples collected at home using OraSure Technologies' DNA Genotek Oragene Dx OGD-510 collection kit, received EUA from the FDA in mid-2020. A few months later, Secaucus, New Jersey-based Phosphorus inked a deal to offer this test at Albertsons Companies' in-store pharmacies.

The Scan

Foxtail Millet Pangenome, Graph-Based Reference Genome

Researchers in Nature Genetics described their generation of a foxtail millet pangenome, which they say can help in crop trait improvement.

Protein Length Distribution Consistent Across Species

An analysis in Genome Biology compares the lengths of proteins across more than 2,300 species, finding similar length distributions.

Novel Genetic Loci Linked to Insulin Resistance in New Study

A team reports in Nature Genetics that it used glucose challenge test data to home in on candidate genes involved in GLUT4 expression or trafficking.

RNA Editing in Octopuses Seems to Help Acclimation to Shifts in Water Temperature

A paper in Cell reports that octopuses use RNA editing to help them adjust to different water temperatures.