Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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
MEDCAC Meeting Set for Molecular Pathology Testing
By Christopher P. Young, Editor, G2 Compliance Advisor The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) is meeting on March 24 to consider evidence about the prognostic capability of certain molecular pathology tests that may have...
Exact Sciences Lands Major Payer Coverage for Cologuard Test
By Ron Shinkman, Editor, Laboratory Industry Report Exact Sciences, the Wisconsin-based molecular laboratory, has added an impressive list of names to its roster that are providing some form of coverage or support to its colon cancer assay. Anthem, one of the...
Personal Genome Diagnostics, VA Partner for Precision Oncology Program
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Personal Genome Diagnostics' CancerSelect targeted gene profiling panel has been selected for use in all newly-diagnosed lung cancer patients in the U.S. Department of Veterans Affairs (VA) New...
At Lab Revolution Conference, a Peek Inside Quest’s ‘Lab of the Future’
By Stephanie Murg, Managing Director, G2 Intelligence What does the lab of the future look like? This question was addressed by a broad range of experts at G2 Intelligence’s Lab Revolution 2015 conference, held March 11-13 in Orlando, Florida. Among the speakers...
Coverage for Electron Microscopy Left to MACs
By Christopher P. Young, Editor, G2 Compliance Advisor The Centers for Medicare and Medicaid Services (CMS) has removed the national coverage determination (NCD) for electron microscopy (EM) from the Medicare National Coverage Determinations Internet only manual...
FDA, AACR and ASCO Seeking to Harmonize Companion Diagnostics for Cancer Treatments
By Kelly A. Briganti, Editorial Director, G2 Intelligence Concerned that cancer patients may not receive "optimal care" when there are "multiple targeted therapy-companion diagnostic pairs," the U.S. Food and Drug Administration (FDA), American Association for...