The US Preventive Services Task Force (USPSTF) issued updated recommendations for BRCA-related cancer risk assessment, genetic counseling and testing in the Aug. 20 issue of the Journal of the … [Read more...]
GENETIC TESTING
Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs
September 30, 2019
INSIDE THE INDUSTRY
Government Report Casts Doubt on Cost-Effectiveness of Leading Genetic Colorectal Cancer Screening Test
September 24, 2019
Few of the newfangled consumer genetic testing products have had greater commercial success and visibility than Exact Science's Cologuard colorectal cancer screening test. But a troubling new … [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...]
INDUSTRY TRENDS
Adoption Quickening for Genomic Cancer Testing in Community Settings
September 16, 2019
Clinicians are increasingly using genomic cancer testing in community health care settings, although there are lingering questions about the utility of results. These are the findings of several … [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 … [Read more...]
EMERGING TESTS
Nonculture Molecular Tests Speed Diagnosis of Bloodstream Infections
August 19, 2019
The T2Bacteria Panel (T2Biosystems; Lexington, Mass.) can rapidly and accurately diagnoses bloodstream infections (BSIs) caused by five common bacteria, according to a study published May 14 in the … [Read more...]
TESTING STRATEGY
Upfront Next-Generation Sequencing for Lung Cancer Patients Saves Time, Money
August 5, 2019
Use of upfront next-generation sequencing (NGS) testing at diagnosis of patients with metastatic non-small-cell lung cancer (mNSCLC) is associated with substantial cost savings, according to a study … [Read more...]
WHISTLEBLOWERS
Billing & Coding: Myriad Genetics Pays $9.1 Million to Settle Claims of Falsely Billing Medicare for Hereditary Cancer Tests
July 30, 2019
In March 2018, Myriad Genetics got a piece of mail no lab provider ever wants to see in its inbox: an OIG subpoena asking for billing records in connection with "an investigation into possible false … [Read more...]
