Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
LabCorp Launches Hepatitis C Drug Resistance Tests
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Researchers Call for Regulatory Oversight of Genomic Tests
By Kelly A. Briganti, Editorial Director, G2 Intelligence Three researchers have suggested that the success of genomic testing depends on post-market data collection and analysis to help determine its safety and effectiveness. They further claim that Congressional...
New Test Reveals Individual’s Viral History From Drop of Blood
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies A new test can reveal a person's entire viral exposure history from a single drop of blood, according to a study published June 5 in Science. The VirScan test allows for simultaneous, comprehensive...
Natera Confirms Test for Early Detection of Molar Pregnancy
By Ron Shinkman, Editor, Laboratory Industry Report Natera, the California-based molecular diagnostics company, said it has tweaked its Panorama prenatal test to identify so-called molar pregnancies during the first trimester. Molar pregnancies, which occur in...
Consumers Seek Direct Access to Blood Testing; Most Don’t Know Theranos
By Kelly A. Briganti, Editorial Director, G2 Intelligence A May survey of insured consumers (with self- or employer-sponsored insurance) reveals that many want to be able to monitor their health and wellness independently without getting a doctor's order for blood...
Guidance Fails to Stem Use of Low-Value Preoperative Testing
By Stephanie Murg, Managing Director, G2 Intelligence Efforts to discourage the use of high-cost, low-value preoperative tests—those ordered "in the absence of a specific clinical indication or purpose"—have had little effect on utilization, according to a national...
Nanopore Sequencing Improvements Generate Enthusiasm
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Test Offers Hope for Catching Ovarian Cancer Earlier
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Confusion Hampers Adoption of New Prostate Cancer Screening, Biopsy Strategies
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Skin Test May Diagnose Alzheimer’s, Parkinson’s
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