By Kelly A. Briganti, Editorial Director, G2 Intelligence
Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS). The opportunity to speak at the hearing, titled "Examining the Regulation of Diagnostic Tests and Laboratory Operations," was invitation only…
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By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Prostate-specific antigen (PSA) screening rates, along with the incidence of early-stage prostate cancer, have declined since the 2012 U.S. Preventive Services Task Force (USPSTF) recommendation to remove PSA screening from routine care for average-risk men. Some experts remain concerned about the long-term mortality implications of…
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By Ron Shinkman, Editor, Laboratory Industry Report
Circulogene Theranostics has released a finger-stick test that allows clinicians to monitor the progression of cancer with just a drop or so of blood. The assay will analyze 10 kinds of cancer: Breast, colorectal, lung, gastric, gastrointestinal stromal, hematological, melanoma, ovarian, pancreatic and thyroid. It focuses primarily on…
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By Kelly A. Briganti, Editorial Director, G2 Intelligence
HCA Holdings, Inc. (formerly called Hospital Corporation of America) has settled health care fraud allegations relating to diagnostic testing for $2 million—including payment of damages and penalties. The claims stem from a whistleblower or qui tam lawsuit brought by an HCA employee under the…
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