Palmetto GBA’s Chief Medical Officer will cover how clinical laboratories billing for genetic testing should prepare for Z-Codes at the upcoming Executive War College in New Orleans After multiple delays, UnitedHealthcare (UHC) commercial plans will soon require clinical laboratories to use Z-Codes when submitting claims for certain molecular diagnostic tests. Several private insurers, including UHC, […] The post Preparing for Z-Codes as DEX Genetic Testing Registry Rolls Out to Commercial Health Plans appeared first on Dark Daily ..read more

Tim Stenzel, MD, PhD, will discuss what clinical laboratories need to know about the draft LDT rule, FDA memo on assay reclassification, and ISO-13485 harmonization Many clinical laboratories anxiously await a final rule from the US Food and Drug Administration (FDA) that is expected to establish federal policies under which the agency will regulate laboratory […] The post Former FDA Director to Speak at Executive War College on FDA’s Coming Regulation of Laboratory Developed Tests appeared first on Dark Daily ..read more

New biomarker may lead to new clinical laboratory testing and treatments for long COVID Researchers studying long COVID at the University Hospital of Zurich (UZH) and the Swiss Institute of Bioinformatics (SIB), both in Switzerland, have discovered a protein biomarker in blood that indicates a component of the body’s innate immune system—called the complement system—remains […] The post Swiss Research Study into Long COVID Promises New Diagnostic and Therapeutic Possibilities appeared first on Dark Daily ..read more

Tim Stenzel, MD, PhD, will discuss what clinical laboratories need to know about the draft LDT rule, FDA memo on assay reclassification, and ISO-13485 harmonization Many clinical laboratories anxiously await a final rule from the US Food and Drug Administration (FDA) that is expected to establish federal policies under which the agency will regulate laboratory […] The post Former FDA Director to Speak at Executive War College on FDA’s Coming Regulation of Laboratory Developed Tests appeared first on Dark Daily ..read more

Biomarker may lead to clinical laboratory testing that enables clinical pathologists and urologists to diagnose risk for diabetic kidney failure years before it occurs Clinical laboratories working with nephrologists and urologists to diagnose patients experiencing urinary system difficulties know that albumin (excessive protein found in the urine) is a common biomarker used in clinical laboratory […] The post Scientists at UT Health San Antonio Discover New Biomarker for Diabetic Kidney Disease appeared first on Dark Daily ..read more

Research could lead to similar treatments for other diseases, as well as creating a demand for a new line of oncology tests for clinical labs and pathology groups Cancer treatment has come a long way in the past decades, and it seems poised to take another leap forward thanks to research being conducted at Rice […] The post Rice University Researchers Develop ‘Molecular Jackhammer’ That Kills Cancer Cells appeared first on Dark Daily ..read more

Switching from non-profit to for-profit may affect how clinical laboratories operate in the new healthcare system Shifting away from fee-for-service payment models and towards value-based healthcare is the goal of many non-profit hospital systems. One such transformation is underway at Summa Health, one of the largest integrated delivery networks (IDNs) in Ohio. On January 17, […] The post Private Equity Firm General Catalyst to Buy Integrated Delivery Network Summa Health as Testing Ground for New Venture appeared first on Dark Daily ..read more

Forces in play will directly impact the operations and financial stability of many of the nation’s clinical laboratories With significant regulatory changes expected in the next 18 to 24 months, experts are predicting a “Perfect Storm” for managers of clinical laboratories and pathology practices. Currently looming are changes to critical regulations in two regulatory areas […] The post Perfect Storm of Clinical Lab and Pathology Practice Regulatory Changes to Be Featured in Discussions at 29th Annual Executive War College appeared first on Dark Daily ..read more

Following the loss of its histology accreditation, pressure on APS laboratory continues to mount Government-run healthcare systems around the world often under-invest as demand grows and new healthcare technologies enter clinical practice. One such example is taking place in New Zealand, where public pathology and medical laboratory services are under extreme stress as physician test […] The post Increased Testing Demands from Physicians is Putting New Zealand Clinical Laboratories Under Severe Stress appeared first on Dark Daily ..read more

New non-invasive test could replace traditional painful spinal taps and clinical laboratory fluid analysis for diagnosis of Parkinson’s disease Scientists at AXIM Biotechnologies of San Diego have added another specimen that can be collected non-invasively for rapid, point-of-care clinical laboratory testing. This time it is tears, and the diagnostic test is for Parkinson’s disease (PD). […] The post AXIM Biotechnologies Develops Diagnostic Test for Parkinson’s Disease That Uses Tear Drop Specimens and Returns Results in Less than 10 Minutes at the Point of Care appeared first on Dark Daily ..read more