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FDA Authorizes Sale of First Direct-to-Consumer Genetic Test
Developed by the company 23andMe, the test identifies carriers of a gene mutation that could determine the susceptibility of a person's offspring to Bloom Syndrome.
The U.S. Food and Drug Administration today authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder.
Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market.
Read the FDA press release: http://1.usa.gov/185XnWe
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Impact of Amivantamab-Lazertinib on EGFR, MET Resistance Alterations in NSCLC: Danny Nguyen, MD
September 15th 2025The combination of amivantamab and lazertinib in first-line non–small cell lung cancer (NSCLC) significantly reduces resistance mechanisms with implications for second-line treatment, said Danny Nguyen, MD, of City of Hope.
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