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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
OIG Issues Mid-Year Work Plan Update
By Kelly A. Briganti, Editorial Director, G2 Intelligence Each year, the U.S. Department of Health and Human Services' Office of Inspector General's (OIG's) Work Plan highlights the projects and reviews it will pursue in the coming year. At the end of May, the OIG...
Walgreens to Offer OraSure’s Hepatitis C Test Free of Charge for Some Store Patrons
By Ron Shinkman, Editor, Laboratory Industry Report The Chronic Liver Disease Foundation has teamed up with retail giant Walgreens to offer free testing for hepatitis C at the latter's drugstores. The testing will start this August and will run through January 2016...
Genomics ‘Nonexceptional’ Compared to Adoption of Other Technologies
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Contrary to wide-held belief, there is nothing exceptional about genomic medicine that would preclude physicians from readily incorporating genetic assessment and testing into routine clinical...
Genomic Sequencing Sheds New Light on Advanced Prostate Cancer
By Stephanie Murg, Managing Director, G2 Intelligence A precision medicine approach is yielding valuable new insights into a common, aggressive form of prostate cancer. Researchers sequenced the DNA and RNA of tumor biopsy samples from 150 men with metastatic,...
Palmetto GBA Issues Proposed Draft LCD for Oncotype DX® Prostate Cancer Assay
By Kelly A. Briganti, Editorial Director, G2 Intelligence Prostate cancer testing has received significant attention lately as the industry seeks to find reliable ways of identifying the appropriate treatment strategy for patients diagnosed with such cancer. A new...