Skip to main content
Premium Trial:

Request an Annual Quote

Dx Focus: GenMark Submits RV Panel for 510(k) Clearance; CE Mark for Nanosphere Blood Culture Test

Premium

GenMark Diagnostics said this week that it has submitted a respiratory viral panel for use on its eSensor XT-8 system to the US Food and Drug Administration for 510(k) clearance.

The test is designed to identify multiple viruses from individuals showing symptoms of respiratory infection.


Nanosphere said this week that it has obtained a CE IVD Mark for a gram-positive blood culture nucleic acid test that runs on its automated Verigene system.

The BC-GP test provides genus- and species-level detection for a broad panel of clinically significant gram-positive bacteria, as well as markers for antibiotic resistance, including the mecA, vanA, and vanB genes.

The test provides results within two and a half hours, which the company said improves upon current microbiological methods that can take two to three days.

The Scan

Study Finds Sorghum Genetic Loci Influencing Composition, Function of Human Gut Microbes

Focusing on microbes found in the human gut microbiome, researchers in Nature Communications identified 10 sorghum loci that appear to influence the microbial taxa or microbial metabolite features.

Treatment Costs May Not Coincide With R&D Investment, Study Suggests

Researchers in JAMA Network Open did not find an association between ultimate treatment costs and investments in a drug when they analyzed available data on 60 approved drugs.

Sleep-Related Variants Show Low Penetrance in Large Population Analysis

A limited number of variants had documented sleep effects in an investigation in PLOS Genetics of 10 genes with reported sleep ties in nearly 192,000 participants in four population studies.

Researchers Develop Polygenic Risk Scores for Dozens of Disease-Related Exposures

With genetic data from two large population cohorts and summary statistics from prior genome-wide association studies, researchers came up with 27 exposure polygenic risk scores in the American Journal of Human Genetics.