Clinical Laboratory Accuracy and Quality Is under Increased Scrutiny as Precision Medicine Puts Diagnostics in the Spotlight

As the public gains awareness of the role clinical laboratories play in modern healthcare, increased engagement and understanding of the technology underlying many of these advances could create risk for labs without transparent reporting protocols to both patients and the public In recent years, consumers have continually raised the bar in their expectation of quality when they interact with the healthcare system. Not only do patients expect providers—including clinical laboratories and...

Clinical Laboratories May Need to Expand Test Portfolios with Companion and Complementary Diagnostic Assays as More Test-Dependent Drug Therapies Enter Market

However, the distinction between how the two different types of diagnostic tests are intended to be used still confuses many physicians and healthcare professionals Companion diagnostics are well-known to medical laboratorians. However, the new-breed of complementary diagnostics might not be as familiar. As the pharmaceutical pipeline increasingly becomes filled with test-dependent new drug therapies, medical laboratories and anatomic pathology groups may need to sharpen their understanding of...

Could ‘Money Back’ Guarantees Become More Common for Medical Devices, Clinical Laboratory Tests, and Prescription Drugs as Manufacturers Strive to Prove Clinical Value?

Examples already exist of manufacturers agreeing to refund payments if their therapeutic drugs don’t benefit patients; Medical laboratories with proprietary tests may find this strategy effective at guaranteeing the clinical utility of their assays If their medical devices, medical laboratory tests, or prescription drugs are not effective, will payers, patients, and doctors get refunds from the manufacturers of these products? Some experts predict that the increased emphasis on improved...

At Lab Quality Confab in New Orleans this Week, Speakers Addressed Major Issues Faced by Medical Laboratories, including the Need for Labs to Deliver More Diagnostic Value to Physicians

‘Best of class’ clinical laboratories and anatomic pathology groups shared case studies in effective cost-cutting and steps they are taking to add value to lab testing services NEW ORLEANS, LOUISIANA—Here in the Crescent City this week, almost 300 clinical laboratory managers and pathologists gathered to learn and master the latest innovations in managing cost in medical laboratories, while introducing high-value medical laboratory testing services that help physicians deliver...

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...