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MDxHealth's Irvine Laboratory Receives ISO 9001:2008 Certification

NEW YORK (GenomeWeb News) – MDxHealth today said that it has received ISO 9001:2008 certification of its Irvine, Calif.-based laboratory.

The laboratory is CLIA-certified and CAP-accredited, and ISO 9001:2008 certification "confirms that MDxHealth Quality Management System consistently meets customer and regulatory requirements for research, product design, assay development, and clinical molecular diagnostic services and pharmaco clinical trials testing," MDxHealth said.

"As companion diagnostic assays play an increasingly important role in the development and validation of new cancer therapies, pharmaceutical companies recognize the importance of quality control even at the earliest stages of research and development," MDxHealth CEO Jan Groen said in a statement. "The ISO certification of our Irvine facility further strengthens our position as a global partner for PharmacoMDx test development."

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.