Attention Pathologists! New Prostate Cancer Test Has CPT Code, NCCN Guideline Recommendation, and Potential Market of One Million Prostate Biopsies Annually

OPKO Health’s 4Kscore test predicts the rate of high-risk prostate cancer and may become a useful business case study for other labs developing proprietary diagnostic tests Clinical laboratories and biotech companies with new medical laboratory tests are struggling to win coverage by Medicare and private payers. How big is this problem? There are currently tens of thousands of molecular diagnostic assays and genetic tests offered for clinical use. Any lab company seeking to obtain an...

Why Public Disclosure of Anatomic Pathology Errors in Canada, But No Similar Events Reported in the United States?

As healthcare systems make patient safety a greater priority, the public reporting of pathology errors in Canada has no comparable track record in the United States Errors in anatomic pathology  testing in the Canadian provinces of Nova Scotia and Saskatchewan made media headlines this summer. In each case, it was just a limited number of cases where errors at pathology labs resulted in inaccurate diagnoses and, in at least one case, a needless mastectomy for a patient. At a time when health...
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