GENETIC TESTING

Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs

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...]

INSIDE THE INDUSTRY

Government Report Casts Doubt on Cost-Effectiveness of Leading Genetic Colorectal Cancer Screening Test

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

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

Genetic Testing: Multigene Panel Testing Detects Hereditary Risk Variants in Metastatic Breast Cancer Patients

The clinical value of performing multigene panel for inherited cancer in patients with metastatic breast cancer has been the subject of considerable debate. Those who believe in the value of such … [Read more...]

INDUSTRY TRENDS

Adoption Quickening for Genomic Cancer Testing in Community Settings

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

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?

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

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

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

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...]


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