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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
Corgenix Gets FDA Clearance for Emergency Use of Its Ebola Test
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In Public Comments, Lab Lobbies Want FDA to Back Off on LDT Regs
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Children’s Hospital Los Angeles Invests $50 Million in Genomic Initiative
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C. Diff Testing Transitioning as Cases Rise
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Test Improves Prediction of Knee Arthritis Progression
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With Technology Advances, Saliva Tests Hold Greater Promise
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OIG Highlights Top 25 Unimplemented Recommendations
By Kelly A. Briganti, Editorial Director, G2 Intelligence The HHS Office of Inspector General (OIG) has issued its opinion on the top things the government isn’t doing that could generate cost savings and improve quality of HHS programs and thus should be an...
Urine Biomarker Test Promises Early Detection of Kidney Cancer
By Stephanie Murg, Managing Director, G2 Intelligence A noninvasive screening method may hold the promise of improved outcomes for patients with kidney cancer, which affects approximately 65,000 people each year in the United States. The key is early diagnosis: If...
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...