This post originally appeared on The Conversation on May 3, 2018. The Food and Drug Administration recently announced its authorization that permits genetics testing company 23andMe to market a test for gene mutations associated with risk of breast and ovarian cancer. In response, 23andMe CEO Anne Wojcicki asserted that...
Tag: Clinical Care Standards
Hawaii’s New End-of-Life Law: Do the Additional Safeguards Withstand Scrutiny?
posted by: Katherine Drabiak, J.D.
This post originally appeared on The Hastings Center Bioethics Forum on May 4, 2018. Last month, Hawaii became the seventh state, with the District of Columbia, to legalize physician-assisted suicide. Similar to some of the other state laws, Hawaii’s Our Care, Our Choice Act permits competent adults with...
Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment
posted by: Katherine Drabiak, J.D.
March 8, 2016
In November 2015, FDA published a startling report, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests, which enumerated serious concerns with the current framework it uses to oversee laboratory developed tests (LDTs). LDTs are tests used by physicians to diagnose disease, predict...