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katherine-drabiakKatherine Drabiak, JD is a legal scholar and Assistant Professor at the University of South Florida College of Public Health. She focuses her research in areas where biotechnology and medical research precede the law. She is interested in how a lack of regulation or circumvention of existing regulation impacts patients and consumers on an individual level; poses conflicts or risks to individuals; and raises questions we must ask as a society about appropriate oversight and utilization of emerging science.

 

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Read Drabiak’s posts from PredictER News, an online publication from Indiana University Center for Bioethics at Indiana University School of Medicine

Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment

Posted by on Mar 8, 2016 in FDA Regulation, Genetic Test, Genomics, Health Law, Regulation of Emerging Technology | Comments Off on Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment

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 risk of disease, and guide critical therapy decisions. This report revealed grave shortcomings in test accuracy, reliability, and ability to provide clinically meaningful information to physicians and patients in a number different tests,...

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