Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
Already a Subscriber? Log in Here
Lab Industry Advisor Subscription
Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
Additional Business Intelligence Offerings
Clinical Diagnostics Insider
Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies
Virtual Events & Webinars
Virtual events & webinars offer a variety of solutions and strategies for dealing with key issues labs face.
Lab Industry Advisor Subscriptions Include
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
ACMG Adds Overused Genetic Tests to the Choosing Wisely Campaign
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The American College of Medical Genetics and Genomics (ACMG) has released a list of five commonly misordered genetic tests that patients and providers should discuss prior to ordering. The...
CAP Accreditation Checklist Update Addresses LDTs
By Kelly A. Briganti, Editorial Director, G2 Intelligence Proactively responding to the debate about laboratory developed tests (LDTs), the College of American Pathologists (CAP) has added new requirements relevant to LDTs to its accreditation checklists. On July...
Roche Seeks FDA Approval of Companion Lung Cancer Test
By Ron Shinkman, Editor, Laboratory Industry Report Pharmaceutical and testing giant Roche has submitted to the U.S. Food and Drug Administration a companion diagnostic for non-small cell lung cancer. The assay, known as the cobas EGFR mutation test, would be used...
AACC Calls for Accuracy, Transparency in Direct-to-Consumer Testing
By Stephanie Murg, Managing Director, G2 Intelligence With the market and media momentum of direct-to-consumer (DTC) testing showing no signs of slowing, the American Association for Clinical Chemistry (AACC; Washington, D.C.) issued a position statement on...