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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
Veracyte Obtains $40 Million in a Private Placement
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Pathway Genomics Introduces Comprehensive Colorectal Cancer Panel
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Highmark Blue Shield Will Make Metamark Assays Available to Enrollees
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Repeal of the SGR Brings Some Uncertainty to the Future Practice of Pathology
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Color Genomics Offers $249 BRCA Test
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At ACLA Meeting, Relief and Resolve in the Wake of Major Policy Changes
By Stephanie Murg, Managing Director, G2 Intelligence What a difference a year makes. That was the prevailing sentiment at the opening sessions of the 20th annual meeting of the American Clinical Laboratory Association (ACLA), which runs through today at the Grand...
Health Care Entities Getting Hit with Costs for Information Security Incidents
By Kelly A. Briganti, Editorial Director, G2 Intelligence As an Oregon health care insurer just experienced, if your lab suffers an information security breach, even due to a lost laptop or flash drive, the Health Insurance Portability and Accountability Act...
Aetna Sues Troubled Laboratory for “Tens of Millions” for Fraud
By Christopher P. Young, Editor, G2 Compliance Advisor Aetna alleges Health Diagnostic Laboratory, Inc. (HDL), and Bluewave Healthcare Consultants, Inc. used kickbacks and inducements to redirect referrals for laboratory testing to HDL, an out-of-network...
Adaptive Biotechnologies, MD Anderson Create Assay to Detect Hodgkin’s Disease
By Ron Shinkman, Editor, Laboratory Industry Report Adaptive Biotechnologies has said it has developed an assay to help detect Hodgkin's disease through a blood draw. The Seattle-based Adaptive worked with the University of Texas MD Anderson Cancer Center in...
Large Survey Finds Return of Research Sequencing Results Desired
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Although there is general interest in receiving genomic results from sequencing study participation, most people do not expect researchers to go out of their way to screen for incidental findings...