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
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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
Wearable Technology Noninvasively Samples, Analyzes Sweat Markers
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Some Common Diagnostic Tests for CKD Unnecessary
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HDL Expects to Enter Settlement With Feds About Doctor Payments
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CMS Pulls Back on Blood Glucose Monitor Regs
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Smaller Esoteric Labs Heading in Different Financial Directions
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The FDA Is Seen as an Unwelcome Guest in the Lab Sector, But Its Presence Is Likely to Grow
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Quest Diagnostics, Vermillion Enter Into New Marketing Agreement for Ovarian Cancer Test
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Rapid Diagnostics Play Prominent Role in Federal Plan to Combat Antibiotic Resistance
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The White House recently unveiled a comprehensive, federal plan to combat the growing threat of antibiotic-resistant bacteria. Diagnostics play a prominent role in the national action plan. The...
CAP, AMP, ASCP and ASCO Welcome Public Comment on Colorectal Cancer Guidelines
By Kelly A. Briganti, Editorial Director, G2 Intelligence Clinical practice guidelines addressing colorectal cancer testing were released for public comment, through the joint efforts of the American Society for Clinical Pathology (ASCP), the College of American...
Rosetta Genomics Obtains Patent for Kidney Cancer Test
By Ron Shinkman, Editor, Laboratory Industry Report New Jersey-based Rosetta Genomics has received a patent for its kidney cancer assay, the company announced this week. Rosetta received a patent for its gene expression test, which can identify four types of kidney...