Sales of Direct-to-Consumer Clinical Laboratory Genetic Tests Soar, as Members of Congress Debate How Patient Data Should be Handled, Secured, and Kept Private

Direct-to-consumer (DTC) genetic testing has been much in the news of late and clinical laboratories, anatomic pathology groups, and biomedical researchers have a stake in how the controversy plays out. While healthcare consumers seem enamored with the idea of investigating their genomic ancestry in growing numbers, the question of how the data is collected, secured, and distributed when and to whom, is under increased scrutiny by federal lawmakers, bioethicists, and research scientists....

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

Media coverage of a recent Orig3n promotion-and intervention from state and federal officials-reveals the level of discomfort public and policymakers have for handling the publics’ protected health information, including genetic test data Is it appropriate to offer free genetic tests to 70,000 fans attending a professional football game? Apparently not, say federal and state healthcare regulators who took steps to block a planned free genetic test giveaway that the Baltimore Ravens and...

Pathologists at South Carolina Hospital Are Preparing to Use Next Generation Gene Sequencing for Cancer Patients

Strategic collaboration promises leap forward in personalized medicine that could be game-changing for medical laboratories One early effort to apply next generation gene sequencing to cancer diagnostics and therapeutics is a collaboration that involves Greenville Hospital System University Medical Center (GHS) in Greenville, South Carolina, and Lab21, Inc., a British company. GHS wants to use next gene sequencing as an integral part of the evaluation of every cancer patient cared for in the...

New IOM Report Calls for Tougher Rules on Physician Relations with the Medical Industry

Goal is to address conflict of interest in clinical studies and CME programs Each year, clinical laboratories and laboratory medicine associations receive less financial support from industry vendors and suppliers. This is a response to tougher Medicare compliance requirements and tighter ethics guidelines. Now comes a report from the Institute of Medicine calling for further reforms on how companies work with physicians to conduct clinical trials and publicize the findings. The IOM...
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