1. Direct-to-consumer genetic testing company 23andMe received FDA clearance for its DNA test that helps detect a hereditary colorectal cancer syndrome. The DNA test will search user’s DNA for two genetic variants that influence MUTYH-associated polyposis, a rare condition linked to an increased risk of colorectal cancer.
2. Verily Study Watch received FDA clearance as a prescription-only device that records, stores, transfers and displays wearers’ heart rhythms via an on-demand electrocardiogram feature.
3. Aptima Mycoplasma genitalium Assay is the first test to help diagnose Mycoplasma genitalium, also known as M. gen., a sexually transmitted infection.
4. The FDA approved the 0.5 milliliter dose of Fluzone Quadrivalent to include children between 35 months old and age 6.
5. ImmunoCAP Specific IgE was approved as a new blood test for in vitro use. It detects peanut sensitivity.
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23andMe gets FDA approval for another direct-to-consumer cancer test
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