The debate over the need for genetic testing of all breast cancer patients for germline pathogenic or likely pathogenic variants in BRCA1, BRCA2 and other breast cancer-linked genes continues with the … [Read more...]
FDA WATCH
FDA Watch: Agency Resounds the Alarm on Biotin Test Interference
November 19, 2019
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
Testing Trends: AMP Creates New Quality Guidelines for PGx Laboratory Testing
October 16, 2019
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...]
GENETIC TESTING
LDTs: FDA Cracks Down on Marketing of Non-Approved PGx Medication Response Tests
September 24, 2019
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...]
GENETIC TESTING
Genetics Update: Internet Use Can Help Patients Self-Diagnose Rare Genetic Disorders
September 10, 2019
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...]
COMPLIANCE
Genetic Testing Fraud Prosecutions are on the Rise around the Country. Are Your Genetic Testing Practices Compliant?
September 10, 2019
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...]
TESTING TRENDS
Genetics Update: 23andMe Seeks to Upend the Medical Industry via Genetic Testing Information Sharing
August 27, 2019
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...]
TESTING TRENDS
Genetic Testing Guidelines for Hereditary Cancer Miss Many At Risk
July 28, 2019
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...]
GENETIC TESTING
Expanded Access to Genetic Testing for Cardiomyopathy Is Cost Effective
July 22, 2019
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...]
GENETIC TESTING
Guidelines at a Glance
July 22, 2019
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...]
