Federal Regulators Issue Notice to DTC Test Company Orig3n That Its Purchase of Interleukin Genetics Could Involve CLIA Compliance Issues

CMS sends letter to Orig3n notifying the genetic test company that it may not have the required certifications to market its genetic tests Orig3n’s recent ill-fated “DNA Day” promotion to offer free genetic tests during an NFL football game this past fall pushed Orig3n into the media spotlight. The Massachusetts-based biotech company—which sells 18 different DNA tests on its website—suspended the promotion due to questions from the Centers for Medicare and Medicaid Services (CMS) and the...

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...

Recent Study Confirms that Clinical Laboratories and Pathologists Have an Opportunity to Help Educate Consumers in Key Health Information, such as Cholesterol, and Blood Glucose Levels

Reviewing medical laboratory test results online is a popular resource among consumers, says a different study by Kaiser Permanente More than half of patients and consumers have trouble understanding their health information, along with the steps needed to further improve their health, according to a recent study conducted by HealthMine. This gap in consumer understanding represents a great opportunity for clinical laboratories and pathology groups that want to forge stronger bonds with...

Clinical Pathology Laboratories File Petition Against Threat of Regulation of Laboratory-Developed Tests

FDA intends to pursue regulation of laboratory-developed tests (LDTs) as medical devices, according to FDA Commissioner Hamburg FDA regulation of laboratory-developed tests (LDTs) is getting attention again. In recent weeks, FDA Commissioner Margaret Hamburg, M.D. put the clinical laboratory industry on notice that the commission intends to pursue regulation of LDTs. Pathologists and clinical laboratory scientists have long used LDTs to solve clinical diagnostic problems and as a way to use...