UW Medicine Researchers Identify Blood Cell Genetic Mutations That Can Disrupt Liquid Biopsy Results
The discovery is yet another factor that must be considered when developing a liquid biopsy test clinical laboratories can use to detect cancer How often do disruptive elements present in Liquid biopsies result in misdiagnoses and unhelpful drug therapies for cancer?...
Former Wall Street Journal Reporter John Carreyrou Reveals Ex-Theranos CLIA Laboratory Director and Pathologist Was Main Source for 2015 Investigation into Theranos
WSJ reporter affirms that the pathologist was his “first and most important source” in confirming the problems at the now-defunct medical lab testing company During the federal fraud trial of Theranos Founder and former-CEO Elizabeth Holmes, no one has spent more days...
Researchers Identify Antibodies That Could Be Protective Against Multiple Sarbecoviruses, Including SARS-CoV-2 and Its Variants
The antibodies target portions of the SARS-CoV-2 spike protein that resist mutation, potentially leading to better treatments and vaccines One challenge in the battle against COVID-19 is the emergence of SARS-CoV-2 variants, especially the Delta variant, which may be...
UCSD Researchers Develop a Wearable Skin Patch That Monitors Blood Pressure, Glucose Levels, and Other Biomarkers in Human Sweat
Skin patch technologies could enable clinical laboratories to monitor patients’ vitals and report to medical professionals in real time Pathologists and clinical laboratory leaders have read many Dark Daily ebriefings on the development of skin patches over the years...
Former Theranos Lab Director and Staff Testify in Ongoing Elizabeth Holmes Fraud Trial That They Voiced Concerns about Reliability and Accuracy of Edison Blood-Testing Device
Four-star general Jim Mattis testified that he eventually “didn’t know what to believe about Theranos anymore,” The Wall Street Journal reported Former-Theranos CEO Elizabeth Holmes was known for her obsession with Steve Jobs, imitating not only the late Apple CEO’s...
India’s Neuberg Diagnostics Embraces AI and Digital Pathology While Opening Its First Clinical Laboratory in the US
One of the world’s fastest growing medical laboratory companies in India is using digital pathology systems and AI to replace older diagnostic technologies Artificial intelligence (AI) is gaining acceptance around the world and use of AI to analyze digital pathology...
Text Messages Between Theranos Founder Elizabeth Holmes and Ex-Boyfriend Ramesh “Sunny” Balwani Grab Headlines in Early Days of Fraud Trial
Romantic musings between the now-defunct Theranos’ CEO and COO may be introduced to undercut Holmes’ claims of ‘intimate partner abuse’ Medical laboratory professionals did not have to wait long for the first prosecution bombshell to explode during the opening week of...
Lithuanian Researchers Develop Novel Noninvasive Method for Diagnosing Melanoma That Has Greater than 90% Accuracy
Computer-aided diagnostic system combines optical dermatoscopy, spectrophotometry and high-frequency ultrasound imaging techniques to differentiate malignant lesions from benign moles Detecting skin cancer via the use of skin biopsies is the bread and butter of many...
New Star Trek-like Handheld Device under Development That Can Detect SARS-CoV-2 in People and on Surfaces
Intriguing technology may find immediate value in assisting the detection and tracking of COVID-19 worldwide Pathologists and clinical laboratory personnel old enough to have watched Star Trek on television will recall the tricorder, a multi-functional handheld device...
Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults
The ongoing study shows promise in the general development of self-powered wearable biosensors, the researchers say, in a development that has implications for clinical laboratory testing Years back, it would be science fiction to describe a wearable garment that can...
Proof-of-Concept Study at University of Colorado Boulder Shows Dynamic Tattoos Can Help Detect and Track Health Issues
If tattoos can accurately be used in the diagnostic process, might clinical laboratories soon offer these types of diagnostic tattoos at their patient service centers? Could color-changing tattoos help diagnose illnesses? Researchers at the ATLAS Institute at the...
German Feasibility Study Shows Cerenkov Luminescence Imaging May Provide New Technique for Identifying Positive Margins during Prostatectomies
Prostate cancer currently has the highest positive surgical margin rate of any cancer in men, with 21% of patients left with cancer cells at the resection site Cancer surgeons may soon have a new technology to help them completely remove cancerous tissue during...
Department of Justice Recovers $1.8B from Medical Laboratory Owners and Others Accused of Alleged Healthcare Fraud During COVID-19 Pandemic
It did not take long for fraudsters to pursue hundreds of billions of federal dollars designated to support SARS-CoV-2 testing and it is rare when federal prosecutors bring cases only a few months after illegal lab testing schemes are identified As if the COVID-19...
Proof of Concept Study Demonstrates Machine Learning and AI Can Identify Cancer Cells Based on pH Levels; May Have Applications in Surgical Pathology
The new method employs a pH sensitive dye and AI algorithms to ‘distinguish between cells originating from normal and cancerous tissue, as well as among different types of cancer’ the researchers said Might a pH-sensitive dye in tandem with an image analysis solution...
Theranos Founder and Former CEO Elizabeth Holmes’ Federal Criminal Fraud Trial Finally Is Under Way in California
Court documents show Holmes’ defense strategy includes accusing ex-boyfriend and former COO Balwani of ‘intimate partner abuse’ that impacted her ‘state of mind’ It has started! The long-awaited criminal trial of former Theranos CEO Elizabeth Holmes is underway in a...
Scientists Identify Growing Number of COVID-19 Variants, But Not All Clinical Laboratories Have the Capability to Test for Variants
Fear that immunity-resistant mutations of SARS-CoV-2 will emerge are real and the scientific community is paying close attention Detection of an increasing number of new variants of the SARS-CoV-2 coronavirus raises the possibility that a new strain of COVID-19 might...
Dey Laboratory Research Finds Bile Acids Affect Gut Motility and the Human Microbiome, Insights That May Lead to New Clinical Laboratory Tests
These new findings may affect how microbiology labs and physicians diagnose and treat several gastrointestinal conditions Once again, a research effort has teased out new insights into the role the human microbiome plays in our digestive processes. Microbiologist and...
Forbes Ranks Epic’s Judith Faulkner the Richest Woman in Healthcare in Its 2021 List of 100 Richest Self-Made Women in US
Within the in vitro diagnostics and clinical laboratory space, Bio-Rad’s Alice Schwartz and 23andMe’s Anne Wojcicki also were recognized by Forbes At $6.5 billion net worth, Forbes, in its 2021 list of the 100 richest self-made women in the US, ranked Judith Faulkner,...
Large Dutch Survey Shines Light on Fraud and Questionable Research Practices in Medical Studies Published in Scientific Journals
About half of nearly 7,000 respondents admitted to sloppy practices, which suggests that pathologists and clinical lab professionals may want to be skeptical about the findings of many papers published in medical journals It may surprise pathologists and medical...
SUNY Upstate Medical University and NUAIR Complete Trial Delivery Service of Medical Supplies on Campus Using Unmanned Drones
Goal of university’s yearlong CHURP test was to validate the use of unmanned aircraft systems (UAS), commonly known as drones, in the delivery of medical supplies across SUNY’s campus Just as hospital systems worldwide are exploring the feasibility of using drone...
Ireland’s ‘CervicalCheck’ Cancer Screening Program Remains Plagued by Controversy Despite Reform Efforts
Two US clinical laboratories providing testing for the problem-laden program have been targets of lawsuits from women who allege their smear test results were misread In Ireland, the nation’s health service continues to deal with the consequences from problems with...
New AI-based Digital Pathology Platform Scheduled to Roll Out across Europe Promises Faster Time to Diagnosis, Increased Accuracy, while Improving Pathologists’ Work Lives
As the worldwide demand for histopathology services increases faster than the increase in the number of anatomic pathologist and histopathologists, a DP platform that suggests courses of treatments may be a boon to cancer diagnostics Europe may become Ground Zero for...
UK Continues to Use Innova’s SARS-CoV-2 Antigen Rapid Test Despite Recall and FDA Warning Letter
FDA cites ‘risk of false results’ and concerns about labeling and ‘performance claims’ in its official warning letter to Innova, a company with connections to Chinese firms By many standards, the US government’s response to the COVID-19 pandemic has been phenomenal....
Another Milestone for CRISPR-Cas9 Technology: First Trial Data for Treatment Delivered Intravenously
Unlike most other CRISPR/Cas-9 therapies that are ex vivo treatments in which cells are modified outside the body, this study was successful with an in vivo treatment Use of CRISPR-Cas9 gene editing technology for therapeutic purposes can be a boon for clinical...
Ransomware Strikes Hospitals, Clinical Laboratories, and Medical Clinics without Warning and Is Now a Major Threat to all Healthcare Organizations
Across the nation, healthcare attorneys and others report that ransomware attacks are happening weekly, and that once providers’ data systems are encrypted, they have few options to regain control of their information systems Ransomware is now the single biggest...
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Getting Paid for COVID-19 Test Claims: What Every Clinical Lab Needs to Know to Maximize Collected Dollars
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Prepare Your Clinical Lab for Double the Regulatory, Compliance, and Managed Care Risk in 2021: The Simultaneous Need to Deal with COVID-19 and Routine Testing Activities
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COVID-19 Employee Testing and Screening Programs: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues
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