Former FDA Director to Speak at Executive War College on FDA’s Coming Regulation of Laboratory Developed Tests
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)...
Swiss Research Study into Long COVID Promises New Diagnostic and Therapeutic Possibilities
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...
Scientists at UT Health San Antonio Discover New Biomarker for Diabetic Kidney Disease
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...
Rice University Researchers Develop ‘Molecular Jackhammer’ That Kills Cancer Cells
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...
Private Equity Firm General Catalyst to Buy Integrated Delivery Network Summa Health as Testing Ground for New Venture
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...
San Diego University Researchers Believe Bacteriophages May Be the Future of Eradicating Multi-Drug Resistant Superbugs
Clinical laboratories and microbiologists may soon have new powerful tools for fighting antimicrobial resistant bacteria that saves lives Superbugs—microbes that have developed multidrug resistance—continue to cause problems for clinical laboratories and hospital...
Perfect Storm of Clinical Lab and Pathology Practice Regulatory Changes to Be Featured in Discussions at 29th Annual Executive War College
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...
Increased Testing Demands from Physicians is Putting New Zealand Clinical Laboratories Under Severe Stress
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...
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
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,...
Scientists Close in on Elusive Goal of Adapting Nanopore Technology for Protein Sequencing
Technology could enable medical laboratories to deploy inexpensive protein sequencing with a handheld device at point of care and remote locations Clinical laboratories engaged in protein testing will be interested in several recent studies that suggest scientists may...
Tufts Medicine Study Shows Rapid Whole Genome Sequencing Highly Successful at Screening Newborns for Cancer in Children’s Hospitals
Pathologists and clinical laboratories have an opportunity to help create newborn rWGS programs in their parent hospitals and health systems Diagnosing disease in infants is particularly difficult using typical clinical laboratory testing and modalities. Thus, the use...
Stanford University Scientists Discover New Lifeform Residing in Human Microbiome
Though they are a mystery, once solved, Obelisks could lead to new biomarkers for clinical laboratory testing Microbiologists and clinical laboratories know that human microbiota play many important roles in the body. Now, scientists from Stanford University have...
Change Healthcare Cyberattack Disrupts Pharmacy Order Processing for Healthcare Providers Nationwide
Initially thought to be an attack by a nation-state, actual culprit turned out to be a known ransomware group and each day brings new revelations about the cyberattack Fallout continues from cyberattack on Change Healthcare, the revenue cycle management (RCM) company...
New Zealand Clinical Laboratories to Undergo Health and Safety Checks after Workers Contract Typhoid, Others Exposed to Chemicals
This comes on top of months of strikes by NZ medical laboratory workers seeking fair pay and safe working conditions Te Whatu Ora (aka, Health New Zealand, the country’s publicly funded healthcare system) recently ordered health and safety checks at multiple clinical...
BMJ Oncology Study Shows 79% Increase in Cancer among People under 50 Years of Age
Findings suggest new medical guidelines may be needed to determine when to perform clinical laboratory cancer screenings on people under 50 From 1990-2019, new diagnoses of early-onset cancer in individuals under 50 years of age increased by 79%, according to a...
A Dark Daily Extra!
This is the third of a three-part series on revenue cycle management for molecular testing laboratories and pathology practices, produced in collaboration with XiFin Inc. Automation and AI-Powered Workflow Paves the Way for Consistent, Optimized Molecular Diagnostics...
New Federal Rules on Sepsis Treatment Could Cost Hospitals Millions of Dollars in Medicare Reimbursements
Some hospital organizations are pushing back, stating that the new regulations are ‘too rigid’ and interfere with doctors’ treatment of patients In August, the Biden administration finalized provisions for hospitals to meet specific treatment metrics for all patients...
UK Study Claims AI Reading of CT Scans Almost Twice as Accurate at Grading Some Cancers as Clinical Laboratory Testing of Sarcoma Biopsies
Radiological method using AI algorithms to detect, locate, and identify cancer could negate the need for invasive, painful clinical laboratory testing of tissue biopsies Clinical laboratory testing of cancer biopsies has been the standard in oncology diagnosis for...
Stanford Researchers Use Text and Images from Pathologists’ Twitter Accounts to Train New Pathology AI Model
Researchers intend their new AI image retrieval tool to help pathologists locate similar case images to reference for diagnostics, research, and education Researchers at Stanford University turned to an unusual source—the X social media platform (formerly known as...
University of Gothenburg Study Findings Affirm Accuracy of Clinical Laboratory Blood Test to Diagnose Alzheimer’s Disease
Already-existing clinical laboratory blood test may be new standard for detecting Alzheimer’s biomarkers In Sweden, an independent study of an existing blood test for Alzheimer’s disease—called ALZpath—determined that this diagnostic assay appears to be “just as good...
UCLA Researchers Discover Organisms in Semen Microbiome That Affect Sperm Motility and Male Fertility
Study findings could lead to new clinical laboratory testing biomarkers designed to assess for male infertility Clinical laboratories are increasingly performing tests that have as their biomarkers the DNA and enzymes found in human microbiota. And microbiologists and...
Separate Reports Shed Light on Why CDC SARS-CoV-2 Test Kits Failed During Start of COVID-19 Pandemic
HHS Office of Inspector General was the latest to examine the quality control problems that led to distribution of inaccurate test to clinical laboratories nationwide Failure on the part of the Centers for Disease Control and Prevention (CDC) to produce accurate,...
Australia Moves to Fully Eliminate Cervical Cancer by 2035, Especially in Underserved and Diverse Populations
By emphasizing HPV vaccinations while having clinical laboratories continue to perform Pap smears, Australia’s rate of cervical cancer has dropped notably There is currently a global push to completely eradicate cervical cancer and Australia is leading the way with...
Rice University Researchers Are Developing an Implantable Cancer Therapeutic Device That May Reduce Cancer Deaths by Half
Immunotherapy device could also enable clinical laboratories to receive in vivo biomarker data wirelessly Researchers from Rice University in Houston and seven other states in the US are working on a new oncotherapy sense-and-respond implant that could dramatically...
Scientists in Italy Develop Hierarchical Artificial Intelligence System to Analyze Bacterial Species in Culture Plates
New artificial intelligence model agrees with interpretations of human medical technologists and microbiologists with extraordinary accuracy Microbiology laboratories will be interested in news from Brescia University in Italy, where researchers reportedly have...
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