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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
Theranos Adds Compliance Focused Executives and Board Committee
From - G2 Compliance Advisor
While still facing serious sanctions from CMS, Theranos has been taking steps to rehabilitate its compliance image. The company announced the appointment of…
New FDA Draft Guidance Addresses Companion Diagnostics
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) released another draft guidance document last week that addresses…
U.S. Colorectal Cancer Screening Capacity Exists, Although Actual Rates Remain Low
From - Diagnostic Testing & Emerging Technologies
The United States has the screening capacity to meet colorectal screening goals, but this capacity has so far not translated into increased screening rates, according to a…
Penalties for False Claims Aren’t the Only FCA Risk to Avoid
From - G2 Compliance Advisor
In the last two issues of Lab & Pathology Insider we highlighted new developments concerning the False Claims Act (FCA): the U.S. Supreme Court decision recognizing the…
Use of Cologuard Test Will Be Placed in 2017 HEDIS Guidelines
From - Laboratory Industry Report
Exact Sciences' molecular colorectal cancer test will be included in the National Committee for Quality Assurance's (NCQA) updated guidelines for screening for…