Week in Review: FDA fall IVD roundtable | Next-generation test collaboration | 23andMe layoff

Dear LabPulse Reader,

This week, the lab community's attention turned to the U.S. Food and Drug Administration's fall IVD roundtable meeting, which happened on Tuesday, November 12. The meeting focused on IVD quality system requirements, complaint and adverse event reporting, and corrective and preventive actions -- mostly avoiding the controversial topic of laboratory-developed tests (LDTs).

Collaborative work on testing was also an important topic in the news this week: Mainz Biomed and Thermo Fisher announced an agreement to jointly develop and commercialize Mainz's next-generation colorectal cancer screening test, while Flatiron Health said that it will incorporate Tempus AI's genetic testing directly into its cloud-based electronic medical record platform. Meanwhile, Veravas and Phanes Biotech announced that they will jointly develop a blood-based Alzheimer's disease tau pathology test.

Research funding was prominent as well this week. Brain Tumor Funders' Collaborative issued a request for proposals for a two-year, $500,000 research grant focused on liquid biopsy for primary brain tumors in pediatric, adolescent, young adult, and/or adult patients.

Additionally, embattled genetics firm 23andMe announced that it would lay off approximately 200 employees, 40% of its workforce, as well as discontinuing its therapeutics programs as part of a restructuring plan.

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