CMS

FDA Watch: Agency Okays EIA Technology-Based Lyme Assays

Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]

EMERGING TESTS

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...]

REIMBURSEMENT

Medicare Reimbursement: MIPS Bonuses Are Easy to Earn, IF You Can Get into the Program

On July 11, CMS announced the results of 2018, Year 2 under the Merit-based Incentive Payment System (MIPS). Bottom line: The total number of clinicians participating declined from 1.06 million to … [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...]

FDA

LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims

The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]


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