FDA Warns DTC Genetic Test Firms
This article was originally published in The Tan Sheet
The warning letters are the first FDA sent since it carved out a de novo risk category for DTC carrier screening tests, clearing the path for 23andMe Inc. to relaunch its Personal Genome Service in October.
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Two years of conversations with FDA lead 23andMe back to the health care market with the launch of its Personal Genome Service, focused on carrier screening tests. The firm says its close engagement with FDA improved its customer communication and quality control.
The Google-backed firm's carrier screening assay for a rare disease called Bloom syndrome is the first DTC genetic test to achieve sign off from FDA. More importantly, the marketing authority was awarded in a manner that could significantly streamline the path to market for future DTC carrier-screening assays.
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