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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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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ACLA Meeting Spotlights Value of Clinical Diagnostics in Face of Reimbursement, Regulatory Challenges
From - National Intelligence Report
Despite the looming challenges of a proposed overhaul of the Medicare payment system for clinical laboratory services and…
Kickback Case Settles for Record-breaking $646 Million
From - G2 Compliance Advisor
It has been billed as the largest total amount in U.S. history paid for alleged violations of the Anti-kickback Statute by…
Veritas Launches Below-$1,000 Whole Genome Test
From - Laboratory Industry Report
Veritas Genetics is launching a whole genome test under the four-figure price point…