LEGISLATION

Labs Stop VA from Allowing APRNs to Perform Lab Tests

The laboratory sector has successfully fought a Department of Veterans Affairs (VA) rule that would have allowed advanced practice registered nurses (APRNs) to "perform and supervise" lab testing. … [Read more...]

CLIA

CMS Grants International CLIA Certificate to ImmunID for Laboratory in France

Recognizing a trend in the diagnostics industry with an increasing number of global transactions, deals and partnerships, (see “Inside the Laboratory Industry,” Laboratory Industry Report, p. 4, … [Read more...]

CLIA

CLIA Certificate Granted for Laboratory in France

By Kelly A. Briganti, Editorial Director, G2 Intelligence As recently reported in Laboratory Industry Report (see "Inside the Laboratory Industry," Laboratory Industry Report, p. 4, 3/17/16), the … [Read more...]

ENFORCEMENT

Government Scrutiny of Theranos Increases

Theranos continues to face challenges concerning its Newark, Calif., laboratory as its initial response to Centers for Medicare & Medicaid Services (CMS) failed to resolve inspection issues and … [Read more...]

CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective Oct 1, 2015. There are 36 newly waived complexity tests, the latest approved by the FDA. Once again, the list is dominated by drug-related … [Read more...]

ACMG and AMA Coalition Make LDT Oversight Recommendations to Congress

A coalition of organizations including the American Medical Association (AMA) and American College of Medical Genetics and Genomics (ACMG) have recommended to Congress that oversight of laboratory … [Read more...]

FDA and CMS Address LDT Regulation Before Energy and Commerce Committee

Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug … [Read more...]

More FDA Workshops Focus on NGS Technology

Last year the FDA held workshops to discuss analytical standards for next-generation sequencing (NGS) and use of curated databases for establishing clinical relevance of genetic variants. The FDA … [Read more...]

FDA Looks Back at Successes and Details Plans for 2016, Including LDTs

In a series of three recent FDA Voice blog articles, the FDA looks back at its accomplishments in 2015 and highlights issues on the agenda for 2016. The FDA also issued its annual list of guidance … [Read more...]

FDA Report Asserts Case Studies Support Need for More Oversight of LDTs

The U.S. Food and Drug Administration (FDA) released a 30-plus page report detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and exercise … [Read more...]


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