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


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

For Better Odds

Bloomberg reports that a child has been born following polygenic risk score screening as an embryo.

Booster Decision Expected

The New York Times reports the US Food and Drug Administration is expected to authorize a booster dose of the Pfizer-BioNTech SARS-CoV-2 vaccine this week for individuals over 65 or at high risk.

Snipping HIV Out

The Philadelphia Inquirer reports Temple University researchers are to test a gene-editing approach for treating HIV.

PLOS Papers on Cancer Risk Scores, Typhoid Fever in Colombia, Streptococcus Protection

In PLOS this week: application of cancer polygenic risk scores across ancestries, genetic diversity of typhoid fever-causing Salmonella, and more.