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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
Shift to Gene Panels to Assess Hereditary Cancer Risk Forges Ahead
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies A virtually unlimited number of genes tied to hereditary cancer risk can be simultaneously assessed in commercially available tests given both advances in technology and the Supreme Court's...
Two FDA Workshops Focus on Precision Medicine Issues
By Kelly A. Briganti, Editorial Director, G2 Intelligence Building on discussions started in February this year, the FDA has announced two workshops it will be holding this fall regarding next-generation sequencing standards and use of databases to establish...
Trovagene Develops Urine-Based Liquid Biopsy Test for Lung Cancer Patients
By Ron Shinkman, Editor, Laboratory Industry Report San Diego-based genomic laboratory Trovagene is developing an unconventional approach to liquid biopsies for lung cancer patients, relying on specimens of urine rather than blood. According to Trovagene's...
Air Force Expands Longitudinal Genomics Study
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The Air Force Medical Service (AFMS) in partnership with the Coriell Institute for Medical Research (Camden, N.J.) have launched phase II of the longitudinal Clinical Utility Study (CUS). CUS...
CMS Reports Latest ACO Performance Results Demonstrate Continuing Success
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AHRQ Funding Cuts Threaten Evidenced-Based Testing Advances
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OIG Says Most COOP Health Plans Are Underperforming
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FTC Issues Guidance on Unfair Competition Enforcement
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Shift to Gene Panels to Assess Hereditary Cancer Risk Forges Ahead Despite Reimbursement Hurdles and Concerns About Clinical Utility
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Millenium Health Gets Win on Appeal of POCT Cup Litigation; But What’s Next?
By Kelly A. Briganti, Editorial Director, G2 Intelligence It's been several years but Millenium won an appeal in a lawsuit Ameritox brought against the company arguing Millenium's point-of-care testing (POCT) cup program violated unfair competition laws and the...