Digital Biology & Genetics

FDA announces new market pathway for genetic health risk tests

FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an

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Intermountain partners with 10x Genomics for precision health research

Intermountain Precision Genomics will add 10x Genomics Chromium Genome Solution to Intermountains Translational Science Center.The center already houses several of the latest high-throughput, next-generation sequencing instruments for large-scale whole genome sequencing.The instruments in the Translational Science Center coupled with the technology solutions provided by 10x Genomics, support Intermountain Healthcares initiative to advance precision health to

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FDA advisers urge approval for first gene therapy for inherited disease

A Food and Drug Administration advisory committee unanimously endorsed an experimental gene therapy Thursday for patients with a rare kind of hereditary blindness, setting the stage for a historic approval.If the agency agrees with the recommendation, the one-time treatment would be the first gene therapy cleared in the United States for an inherited disorder.Made by

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Regenerative medicine, gene editing markets are growing

21st Century Cures Act is helping drive expansion in the cellular therapies, with the field valued at $25 billion.When the U.S. Food and Drug Administration issued new guidance earlier this month on how companies who handle human cells, tissues and cellular and tissue-based products should report problems to the agency, it was a recognition that

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