In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The … [Read more...]
Testing Trends: AMP Creates New Quality Guidelines for PGx Laboratory Testing
Pharmacogenetic (PGx) testing has recently come under fire from both the scientific and regulatory community for its lack of self-policing. But the new Association for Molecular Pathology (AMP) … [Read more...]
LDTs: FDA Cracks Down on Marketing of Non-Approved PGx Medication Response Tests
Laboratory Developed Tests (LDTs) are back in the FDA's enforcement crosshairs. This time the target is marketing claims related to the medication predictive qualities of pharmacogenetics (PGx) tests … [Read more...]
Genetics Update: Internet Use Can Help Patients Self-Diagnose Rare Genetic Disorders
The notion of empowering patients to take control over their own health care is particularly powerful within the realm of genomic diagnostics to the extent that patients can theoretically seek their … [Read more...]
Genetic Testing Fraud Prosecutions are on the Rise around the Country. Are Your Genetic Testing Practices Compliant?
By Robert Liles bio Over the last year, a number of genetic testing fraud investigations and prosecutions have been initiated by Medicare, Medicaid and TRICARE investigators and auditors. While the … [Read more...]
Genetics Update: 23andMe Seeks to Upend the Medical Industry via Genetic Testing Information Sharing
Can one company disrupt the entire lab industry? 23andMe seems determined to find out. The Mountain View, California-based personal genomics and biotechnology company, which first marketed its … [Read more...]
Genetic Testing Guidelines for Hereditary Cancer Miss Many At Risk
The National Comprehensive Cancer Network genetic testing criteria for hereditary cancer miss almost one in five at-risk for breast and ovarian cancer, and more than one in three at-risk for Lynch … [Read more...]
Expanded Access to Genetic Testing for Cardiomyopathy Is Cost Effective
Expansion of genetic testing in asymptomatic relatives of patients with dilated cardiomyopathy (DCM) to guide clinical surveillance is cost-effective, according to a study published in Genetics in … [Read more...]
Guidelines at a Glance
Screening for HIV Published June 11 in the Journal of the American Medical Association. The U.S. Preventive Services Task Force (USPSTF) recommends screening for HIV infection in adolescents and … [Read more...]
Routine Urine Test Can Screen for Medication Adherence at Primary Care Visit
A single urine spot sample can be used to objectively screen for nonadherence to diabetes medications in the primary care setting, according to a study published in the June issue of Diabetes Care. … [Read more...]