Genetics 1 min read

23andMe Seeks FDA Approval, 3-D Mammography Gains Ground, CF Drugs Show Promise

By Rhonda Reinhart featured image

FDA to review first health report from 23andMe: In November of last year, the U.S. Food and Drug Administration told genetics company 23andMe to stop offering health-related genetic reports as part of its $99 home DNA kit. But now the company has taken a first step toward FDA approval by submitting for review a health report on a rare condition called Bloom syndrome. In a recent blog post, 23andMe’s chief legal and regulatory officer, Kathy Hibbs, called the submission an “important step” in the company’s work with the FDA: “Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions.”

Study finds that 3-D mammography improves cancer detection: According to a new study published in The Journal of the American Medical Association, tomosynthesis — a test that uses multiple X-rays to create a three-dimensional image of the breast — improved cancer detection and reduced false alarms when used in addition to digital mammograms. Millions of women will undergo 3-D mammography this year, but some experts caution that while these results are promising, they are not definitive.

Drug combo improves lung function in cystic fibrosis patients: Vertex Pharmaceuticals announced this week that a two-drug combination improved lung capacity in cystic fibrosis patients in a pair of late-stage trials. One of the drugs, Kalydeco, is already approved to treat CF in patients who have the rare G551D mutation, but this drug combo targets a genetic mutation that is found in half of CF patients.