Trifecta of forces at work that will affect the clinical laboratory and pathology industries have been described as a ‘perfect storm’ requiring lab and practice managers to be well informed Digital pathology, artificial intelligence (AI) in healthcare, and the perfect storm of changing federal regulations, took centerstage at the 29th Executive War College on Diagnostics, […] The post Laboratory Leaders at 2024 Annual Executive War College Discuss Critical Challenges Facing Clinical Laboratory and Pathology Managers for 2024 and Beyond appeared first on Dark Daily ..read more

FDA announces final rule on Lab-Developed Tests LDTs) as Clinical Lab Leaders Meet in New Orleans Regulatory changes were the talk of the 29th Annual Executive War College, with attendees buzzing about Monday’s  US Food and Drug Administration (FDA) announcement that it had finalized the rule on laboratory developed tests (LDTs). The timing was perfect at the first […] The post Big Industry Changes in Focus at the Annual Executive War College appeared first on Dark Daily ..read more

29th Conference Features Information on What Clinical Lab Leaders Need to Know About a ‘Perfect Storm’ of New Compliance Challenges There are signs that the US Food and Drug Administration (FDA) is poised to release the final rule on laboratory developed tests (LDTs)—perhaps even during the 29th annual Executive War College on Diagnostic, Clinical Laboratory, […] The post From Regulations to Innovations: Annual Executive War College Convenes in New Orleans appeared first on Dark Daily ..read more

In a follow-up story, investigative news team in Boston sends a reporter’s cheek swab sample to the same pet DNA testing lab: report states the reporter is part Malamute, Shar Pei, and Labrador Retriever One pet DNA testing company returned results from human cheek swabs showing two different people were in fact part dog. The […] The post Pet Owner Sends Her Own Cheek Swab Samples to a Pet DNA Testing Laboratory and Gets a Report That She is Part Border Collie and Bulldog appeared first on Dark Daily ..read more

Speedy DNA sequencing and on-the-spot digital imaging may change the future of anatomic pathology procedures during surgery Researchers at the Center for Molecular Medicine (CMM) at UMC Utrecht, a leading international university medical center in the Netherlands, have paired artificial intelligence (AI) and machine learning with DNA sequencing to develop a diagnostic tool cancer surgeons […] The post Artificial Intelligence in the Operating Room: Dutch Scientists Develop AI Application That Informs Surgical Decision Making during Cancer Surgery appeared first on Dark Daily ..read more

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