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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
News at a Glance – Apr 2015
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LabCorp Jumping into DTC Testing, Exploring Drugstore Partnership
By Stephanie Murg, Managing Director, G2 Intelligence Earlier this month, the state of Arizona removed all limits on the kinds of laboratory tests that could be ordered by patients with a bill shepherded into law (it takes effect in July) by Theranos (Palo Alto,...
Physician Practice Agrees to $3.2 Million Settlement of Stark and False Claims Allegations
By Kelly A. Briganti, Editorial Director, G2 Intelligence Laboratory services are at the center of another False Claims Act settlement—this time in an arrangement involving a dermatology practice and its dermatopathology laboratory. A Georgia-based dermatology...
Tumor-Only Sequencing Plagued by False Positives
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Many of the genetic changes detected by sequencing tumor tissue are not actually associated with the cancer, but reflect inherited germline mutations that are also present in non-cancer cells of...
Millennium Pays Ameritox $8.6 Million for Patent Infringement
By Christopher P. Young, Editor, G2 Compliance Advisor In an April 21 award of damages in a patent infringement lawsuit filed by Ameritox and Marshfield Clinic against Millennium Health (MH), formerly Millennium Laboratories, jurors decided that $8,652,760 would...
Study Says Cleveland HeartLab Test Can Cut Heart Attacks, Strokes
By Ron Shinkman, Editor, Laboratory Industry Report A new study by the Cleveland HeartLab and the personalized medicine firm MDVIP concluded that the former's cardiac inflammation assay could significantly reduce the occurrence of heart attacks and strokes....
New Study IDs Income as Significant Barrier to Molecular Testing
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Labs Anxiously Await Pricing for Genome Sequencing Codes
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New Sequencing CPT Codes
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Ambry Acquires Florida Lab Software Firm
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