News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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FDA Grants Marketing Authorization to Diagnostic Tests for Chlamydia and Gonorrhea with At-Home Sample Collection

FDA says the move will make it easier to gain authorization for other clinical laboratory tests to utilize at-home collection kits In another sign of how diagnostic testing is responding to changing consumer preferences, the US Food and Drug Administration (FDA)...

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Cambridge Researchers in UK Develop ‘Unknome Database’ That Ranks Proteins by How Little is Known about Their Functions

Scientists believe useful new clinical laboratory assays could be developed by better understanding the huge number of ‘poorly researched’ genes and the proteins they build Researchers have added a new “-ome” to the long list of -omes. The new -ome is the “unknome.”...

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New Wearable In-Ear Medical Device Helps Sufferers of Standing-Related Ailments

Device is latest example that wearable healthcare devices are moving past simple biomarker monitoring and into the area of assisting in rehab Companies unrelated to traditional clinical laboratory medicine continue to develop wearable devices that enable individuals...

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Binghamton University Scientists Develop Biobattery That Powers Ingestible Devices and Biosensors Inside the Human Small Intestine

Biobattery might one day power clinical laboratory testing devices designed to function in vivo to measure and wirelessly report certain biomarkers Clinical laboratories may one day regularly process biomarker data sent by ingested medical devices from inside the...

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University of Oxford Researchers Use Spectroscopy and Artificial Intelligence to Create a Blood Test for Chronic Fatigue Syndrome

Spectroscopic technique was 91% accurate in identifying the notoriously difficult-to-diagnose disease suggesting a clinical diagnostic test for CFS may be possible Most clinical pathologists know that, despite their best efforts, scientists have failed to come up with...

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University of Athens Researchers Create Wooden Tongue Depressor with Biosensing Capabilities Capable of Identifying Biomarkers

Scientists believe the biodegradable device could someday help detect multiple saliva biomarkers. If true, it might provide a new type of test for clinical laboratories When it comes to tongue depressors, it turns out you can teach an old dog new tricks. Researchers...

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Researchers at Stanford University Discover Gene Variant That Appears to Protect Individuals from Both Alzheimer’s and Parkinson’s Disease

Study findings may lead to new clinical laboratory tests, as well as vaccines and immunotherapies for neurodegenerative diseases Research into the human genome continues to produce useful new insights. This time, a study led by researchers at Stanford University...

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Asian Company Launches World’s First Diagnostic Test for Microbiome of the Mouth

Collected data could give healthcare providers and clinical laboratories a practical view of individuals’ oral microbiota and lead to new diagnostic assays When people hear about microbiome research, they usually think of the study of gut bacteria which Dark Daily has...

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Stanford Researchers Discover Junk DNA Affects Gene Expression

Research findings could lead to new biomarkers for genetic tests and give clinical laboratories new capabilities to diagnose different health conditions New insights continue to emerge about “junk DNA” (aka, non-coding DNA). For pathologists and clinical laboratories,...

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Wastewater Analysis Continues to be an Effective Tool for Tracking Deadly Infectious Diseases in Human Communities

In addition to viruses, wastewater analysis can also be used to detect the presence of chemical substances such as opioids Wastewater surveillance and analysis continues to be a useful tool for detecting the prevalence of viruses such as SARS-CoV-2, influenza, and...

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In Early Weeks of Flu Season, COVID-19 Patients Show Milder Symptoms as SARS-CoV-2 Continues to Evolve

Doctors report difficulty differentiating COVID-19 from other viral infections, impacting clinical laboratory test orders Because the SARS-CoV-2 coronavirus is in the same family of viruses that cause the common cold and influenza, virologists expected this...

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Google DeepMind Says Its New Artificial Intelligence Tool Can Predict Which Genetic Variants Are Likely to Cause Disease

Genetic engineers at the lab used the new tool to generate a catalog of 71 million possible missense variants, classifying 89% as either benign or pathogenic Genetic engineers continue to use artificial intelligence (AI) and deep learning to develop research tools...

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Healthcare Strikes Around the World Challenge Pay and Poor Working Conditions

Millions of cancelled healthcare appointments and lengthy waits for care abound in UK, New Zealand, and in the US Strikes continue on multiple continents as thousands of healthcare workers walk off the job. Doctors, medical laboratory scientists, nurses, phlebotomists...

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Might Bacteria be Used to Identify Cancer Cells? Some Researchers Using Synthetic Biology and Genetic Engineering Techniques Say ‘Yes’

Cellular healthcare is an approach that goes beyond clinical laboratory testing to identify the location of specific cancer cells and aid in treatment decisions Advances in synthetic biology and genetic engineering are leading to development of bacterial biosensors...

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Data Theft at 23andMe Leaks Genetic and Personal Information for Thousands, Targets Ashkenazi Jews and Chinese

Federal class action lawsuit looms as genetics company searches for what went wrong; a reminder to clinical laboratories of the importance of protecting patient information Several years ago, security experts warned that biotechnology and genomics company 23andMe,...

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Microbiome Firm Raises $86.5 Million and Inks Deal to Sell Consumer Test Kits in 200 CVS Pharmacies

Studying gut bacteria continues to intrigue investors, but can the results produce viable diagnostic data for healthcare providers? Even as microbiologists and clinical pathologists closely watch research into the human microbiome and anticipate study findings that...

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Florida Nurse Practitioner Convicted for Involvement in $200 Million Medicare Fraud Scheme Involving Clinical Laboratory Tests, Other Procedures

Federal prosecutors allege that this nurse practitioner ordered more genetic tests for Medicare beneficiaries than any other provider during 2020 Cases of Medicare fraud involving clinical laboratory testing continue to be prosecuted by the federal Department of...

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Bankruptcies and Store Closings Are Signs of Tough Times Ahead for US Retail Pharmacy Chains

Plans by several national retail pharmacy chains to expand primary care services and even some clinical laboratory test offerings may be delayed because of financial woes Times are tough for the nation’s retail pharmacy chains. Rite Aid Corporation, headquartered in...

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University of Pennsylvania Researchers Use Cellulose to Produce Accurate Rapid COVID-19 Test Results Faster and Cheaper than Traditional PCR Tests

Researchers are working to create accurate rapid COVID-19 tests with lower costs and less waste than existing rapid clinical laboratory tests University of Pennsylvania (UPenn) researchers have developed a biodegradable rapid COVID-19 test that raises the bar on...

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AMA Issues Proposal to Help Circumvent False and Misleading Information When Using Artificial Intelligence in Medicine

Pathologists and clinical laboratory managers will want to stay alert to the concerns voiced by tech experts about the need to exercise caution when using generative AI to assist medical diagnoses Even as many companies push to introduce use of GPT-powered (generative...

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Researchers Use Whole Genome Sequencing to Make Surprising Discovery about Hospital-Acquired C. Diff Infections

By analyzing strains of the bacterium from a hospital ICU, the scientists learned that most infections were triggered within patients, not from cross-transmission Tracking the source of Hospital-acquired infections (HAI) has long been centered around the assumption...

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Rise in Cancer Rates among Young People Contributes to New Phenomenon of ‘Turbo Cancers’ as a Cause for Concern

Clinical laboratories and pathologists should expect to receive increase referrals from oncologists with younger patients More people are getting serious cases of cancer at younger and younger ages. So much so that some anatomic pathologists and epidemiologists are...

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Millions of COVID-19 At-Home Tests Set to Flood Market as HHS Asks 12 Test Manufacturers to Produce 200 Million Tests

Free at home clinical-laboratory testing for COVID-19 has been provided in the past, but this time the federal government wants to manufacture as many tests as possible in the US Pathologists and clinical laboratory managers may be interested to learn that the US...

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