Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
Acute HIV Screening With Combo Assay Ups Diagnostic Yield
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Ambry Genetics Launches Public Genetic Database, Takes Stand on Data Sharing
From - Diagnostic Testing & Emerging Technologies
Ambry Genetics (Aliso Viejo, Calif.) took a stance in the debate over sharing of genetic data this week. The genetic testing firm launched…
Transgenomic Announces Two New Tests for Colorectal Cancer, Melanoma
From - Laboratory Industry Report
Transgenomic has released two new liquid biopsy tests for colorectal cancer and metastatic melanoma…
Federal Fraud and Abuse Recoveries Down from Prior Fiscal Year
From - G2 Compliance Advisor
Despite robust enforcement efforts and large scale investigations and takedowns, the overall recovery received in government coffers last year was…
New IOM Report on Biomarker Tests Calls for Improved Evidence, Oversight
From - National Intelligence Report
Few dispute the promise of personalized—or, more recently, "precision"—medicine, but in a world where…
Neoteryx–A Less Ambitious Version of Theranos?
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FDA Issues Informational Queries to Two Startup Labs
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Smaller Publicly-Traded Labs Report Mixed Results
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As Precision Medicine Initiative Evolves, Labs Play Just a Small Role—for Now
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AACC Issues Position Paper on Regulation of Laboratory Developed Tests
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