Johns Hopkins University Study Finds Laboratory-Developed Liquid Biopsy Tests Can Give Different Results; Call for ‘Improved Certification’ of Medical Laboratories That Develop These LDTs

Liquid biopsy tests hold much promise. But inconsistencies in their findings provoke scrutiny and calls from researchers for further development before they can be considered reliable enough for diagnostic use Many commercial developers of liquid biopsy tests tout the accuracy and benefits of their diagnostic technology. However, there are an equal number of medical laboratory experts who believe that this technology is not yet reliable enough for clinical use. Critics also point out that...

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...

Pathology Testing for Molecular Genetics “Not Ready for Prime Time”

Experts at National Comprehensive Cancer Network conference voice opinions It may surprise many pathologists and clinical laboratory managers to learn that a number of prominent healthcare leaders recently voiced significant reservations about the current status of molecular genetics testing. In their view, clinical pathology laboratory testing that incorporates genetic and molecular technologies needs further refinement, improved billing codes, and additional regulation before it can fulfill...

UnitedHealthcare to Grade Oncologists on Compliance with Care Guidelines

Appropriate use of clinical pathology laboratory tests to detect and treat cancer will be a scorecard factor One primary goal of pay-for-performance programs is to reduce or eliminate the variability of care that physicians provide to their patients. Getting physicians to follow the recommended care protocols 100% of the time with 100% of their patients would contribute to improved outcomes, while reducing overall healthcare costs. Pathologists and clinical laboratory professionals are well...
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