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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
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Trastuzumab Deruxtecan Receives FDA Approval for HER2-Positive Solid Tumors
April 5th 2024FDA granted accelerated approval to trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.
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