Ex-Theranos CEO Elizabeth Holmes Takes Witness Stand in Her Own Defense: Admits to Using Pharma Giants’ Logos on Reports to Investors, But Claims No Intent to Deceive

Former CEO also testified that she believed company’s proprietary blood-testing technology could perform ‘any’ clinical laboratory blood test One relevant question in the federal fraud trial of ex-Theranos CEO Elizabeth Holmes was whether she would testify on her own...

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Retail Giant Nordstrom Now Sells Viome Life Sciences’ Microbiome Testing Kit Online, Will Stock the Test Kit in Some Retail Locations Next Year

Although there are healthcare providers who see the potential in microbiome testing, many clinical laboratories are not yet ready to embrace microbiome-based testing In an unlikely string of events, no less than Nordstrom, the national department store chain,...

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More Countries Are Now Capable of Genome Sequencing and Contributing to Global COVID-19 GISAID Database than Ever Before

GISAID hosts a vast, open database of genomic sequences of SARS-CoV-2 coronavirus samples, and medical laboratory scientists in countries across the globe are contributing Clinical laboratories around the world have been contributing to the global scientific...

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McMaster University Researchers Develop Bioinformatics ‘Shortcut’ That Speeds Detection and Identification of Pathogens, including Sepsis, SARS-CoV-2, Others

Molecular probes designed to spot minute amounts of pathogens in biological samples may aid clinical laboratories’ speed-to-answer Driven to find a better way to isolate minute samples of pathogens from among high-volumes of other biological organisms, researchers at...

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Junk DNA May Not be “Junk” Afterall, but Perform Significant Functions in Ensuring Fertility, and Preventing Cancer and Other Diseases

Recent research into transposons within DNA dark matter may produce new biomarkers for clinical laboratory testing and diagnostics There’s been another interesting development in the study of genetic “dark matter” which may give rise to new biomarkers for clinical...

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Another Former Theranos Clinical Laboratory Director Testifies in Holmes’ Fraud Trial about Irregularities with Proprietary Edison Blood-Testing Technology

Pathologist Kingshuk Das, MD, tells jurors he voided 50,000 to 60,000 blood-tests from a two-year period due to unreliable results As the prosecution in the criminal fraud trial of ex-CEO Elizabeth Holmes closes in on resting its case, a fourth and final former...

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‘Femtech’ Diagnostic Start-up Firms Want to Provide Women with At-Home Tests for Health Conditions That Currently Require Tests Done by Clinical Laboratories

Several young companies hope to expand the direct-to-consumer test market by introducing new diagnostic tests to serve the women’s health market Providing women with at-home lab test kits is the goal of a growing class of start-up companies that are bringing to market...

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Have Low-cost Direct-to-Consumer Genetic Tests Changed Census Results in America?

Citizens claiming racial diversity increased by 276% in the 2020 census, leading experts to wonder if racial diversity is increasing or if people are simply electing to identify as such and how this trend will affect healthcare Once again, we see another unexpected...

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UK Clinical Laboratory Operations Suspended Following Reports of 43,000 False Negative COVID-19 PCR Test Results Over Five-Week Span

Medical laboratory company’s patients in Southwest England previously had tested positive for COVID-19 on a Lateral Flow Device If providing accurate test results is key to maintaining trust with healthcare consumers, a private COVID-19 testing laboratory in the...

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Spatial Transcriptomics Provide a New and Innovative Way to Analyze Tissue Biology, May Have Value in Surgical Pathology

Newly combined digital pathology, artificial intelligence (AI), and omics technologies are providing anatomic pathologists and medical laboratory scientists with powerful diagnostic tools Add “spatial transcriptomics” to the growing list of “omics” that have the...

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Corporate Executives and Mega-Rich Investors Testify in Elizabeth Holmes’ Federal Fraud Trial That They Were Misled by Theranos’ Claims about the Edison Blood-Testing Device

Federal prosecutors moved past the testimony of the pathologist who served for a time as the CLIA laboratory director at Theranos to provide evidence of a second unauthorized use by Theranos of a pharmaceutical company’s intellectual property Building their case...

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Demographic Shift Means Lower Birthrates and Aging Populations around the World, Suggesting Big Changes for Global Healthcare, Pathology Groups, and Clinical Laboratories

Demographic shifts are most acute in Europe and East Asia but could be a harbinger of things to come for US healthcare as well Across the globe, major shifts in many countries’ demographics are starting to drive notable changes in how healthcare is delivered in these...

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New Directions for Clinical Laboratories and Pathology Groups: Executive War College Presents Roadmaps for Success after COVID-19

Self-insured and campus health markets are contract opportunities for small and midsize clinical laboratories through investment in data infrastructure and management Clinical laboratory and pathology group managers do not often hear that they have an opportunity to...

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Executive War College: Efficient Data Structure Can Bring in More Reimbursement Dollars and Allow Clinical Laboratories to Sell Aggregated Information

Speakers at this week’s Executive War College in San Antonio explained that the way records are collected and stored plays a large part in the long-term usefulness of clinical laboratory data Data structure as a term may not flow off the lips of clinical laboratory...

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Prosecutors in Elizabeth Holmes’ Federal Fraud Trial Question Witnesses about Theranos’ Edison Technology and the Inaccurate Medical Laboratory Test Results It Produced

Jury also heard testimony about Holmes’ claims that the Edison device was doing clinical laboratory testing for the military in overseas theaters During the seventh week of ex-Theranos CEO Elizabeth Holmes’ criminal fraud trial, headline-making testimony continued...

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CDC Issues Warning on Candida Auris, a Highly Drug Resistant and Dangerous Yeast Infection

CDC advises clinical laboratories and microbiologists encountering C. auris to follow their own protocols before adopting federal agency guidelines In July, the Centers for Disease Control and Prevention (CDC) warned healthcare facilities and clinical laboratories to...

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FDA Expands Approval of Gastric Emptying Breath Test for Gastroparesis to Include At-home Administration Under Virtual Supervision

It may not be a boom trend, but more non-invasive diagnostic tests are coming to market as clinical laboratory tests that use breath as the specimen Here’s a development that reinforces two important trends in diagnostics: non-invasive clinical laboratory assays and...

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UK Raises Payroll Taxes to Record Levels to Recover COVID-19 Costs for State-Funded National Health Service

Under-resourced British healthcare system faces a record high backlog of care with 5.61 million people in England waiting for hospital-based medical procedures Healthcare in the United Kingdom (UK) is about to become much more expensive. The UK government has...

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Human Salivary Proteome Wiki Developed at University of Buffalo May Provide Biomarkers for New Diagnostic Tools and Medical Laboratory Tests

Proteins in human saliva make up its proteome and may be the key to new, precision medicine diagnostics that would give clinical pathologists new capabilities to identify disease Clinical pathologists may soon have an array of new precision medicine diagnostic tools...

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Media Reporting Shows Some Clinical Laboratories Charge Significantly Higher than Average Prices for COVID-19 Tests—and It Is Perfectly Legal

When people receive COVID-19 testing at an out-of-network facility, federal law requires insurers to pay that clinical laboratory’s posted ‘cash price’ when negotiated prices have not previously been established In the latest example that some COVID-19 testing...

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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?...

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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...

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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...

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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...

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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...

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