Michael Fuller

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Latest Posts › FDA Approval

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23andMe Receives First FDA Authorization for Direct-to-Consumer Cancer Risk Genetic Test

On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help predict a subject’s risk of developing specific cancers. 23andMe already...more

3/27/2018 / 23andMe , Cancer , FDA Approval , Genetic Testing

FDA Approves Keytruda as First Cancer Treatment Based on a Genetic Biomarker

The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more

6/6/2017 / Cancer , FDA Approval , Food and Drug Administration (FDA) , Genetic Markers , Pharmaceutical Patents , Prescription Drugs

FDA Approval of 23andMe Genomic Test Shows the Way for Direct-to-Consumer Diagnostics

On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more

4/21/2017 / 23andMe , FDA Approval , Food and Drug Administration (FDA) , Human Genome Project , Medical Devices

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