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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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”
HHS Declares Enterovirus D68 Significant Potential for Public Health Emergency
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence The U.S. Department of Health and Human Services Secretary issued a notice declaring the enterovirus D68 (EV-D68) poses a “significant potential for a public health emergency that has a significant...
Oncotype DX Use Consistent With Guidelines, Study Finds
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Oncotype DX assay (Genomic Health; Redwood City, Calif.), to assess a patient's risk of recurrence, was adopted quickly in clinical practice after Medicare's positive coverage decision,...
Castle Biosciences Study Reaffirms Efficacy of Predictive Melanoma Test
By Ron Shinkman, Editor, Laboratory Industry Report A new clinical study conducted in conjunction with the Texas-based Castle Biosciences, Inc. suggests that its molecular assay for melanoma patients can assist in determining whether their particular cancer will...
Annual Physician Fee Schedule Game Begins
By Christopher P. Young, Editor, G2 Compliance Advisor The Medicare physician fee schedule (MPFS) will be adjusted to reflect a 21.2 percent negative update effective April 1 unless Congress acts to override or delay the cut as has been the case in previous years....
AMP Releases Tools to Calculate Cost, Demonstrate Value of Genome Sequencing
By Stephanie Murg, Managing Director, G2 Intelligence No discussion of next-generation sequencing (NGS) is complete without a reference to the swiftly plummeting cost of the technology, and yet little effort has made to put a dollar figure on the value of this type...