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BD Gets FDA OK for Group B Strep MDx Assay

NEW YORK (GenomeWeb News) – Becton Dickinson today said that the US Food and Drug Administration has cleared for marketing its BD Max Group B Streptococcus Assay for detection of GBS DNA in Lim Broth cultures.

BD said that the test, which runs on its second-generation BD Max System, received CLIA moderate complexity test categorization. It said that the test is the only automated IVD method for PCR detection of GBS from Lim Broth with a moderate complexity categorization.

Gregory Meehan, VP of BD Diagnostics – Diagnostic Systems, Molecular Diagnostics, said in a statement that the FDA clearance "moves BD closer to our goal of providing a next-generation molecular testing system designed to offer and accommodate a broad range of assays."

The firm is developing methicillin-resistant Staphylococcus aureus and Clostridium difficile assays to run on the system.

The Scan

Panel Votes for COVID-19 Pill

A US Food and Drug Administration panel has voted to support the emergency use authorization of an antiviral pill for COVID-19 from Merck and Ridgeback Biotherapeutics, CNN says.

But Not Harm

New Scientist reports that UK bioethicists say that though gene editing may improve food production, it should not harm livestock welfare.

Effectiveness Drop Anticipated

Moderna's Stéphane Bancel predicts that that current SARS-CoV-2 vaccines may be less effective against the Omicron variant, the Financial Times reports.

Cell Studies of Human Chromatin Accessibility, SARS-CoV-2 Variants, Cell Signaling Networks

In Cell this week: chromatin accessibility maps of adult human tissues, modeling to track SARS-CoV-2 variants of concern, and more.