Mobile Device Software Companies Are Developing Smartphone Apps That Use Artificial Intelligence to Test for COVID-19, Potentially Bypassing the Clinical Laboratory Altogether

This is another example of technology companies working to develop medical laboratory testing that consumers can use without requiring a doctor’s order for the test Here’s new technology that could be a gamechanger in the fight against COVID-19 if further research...

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FDA’s Regulatory Hurdles ‘Paralyzed’ Efforts of CLIA-Certified Clinical Laboratories to Offer Alternatives to CDC’s Flawed COVID-19 Test, Part Two of Two

Washington Post investigation outlines scientists’ frustrations in the early days of the pandemic, as they worked to deploy laboratory-developed tests for the novel coronavirus In the wake of the failed rollout of the Centers for Disease Control and Prevention’s (CDC)...

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Washington Post Investigation into CDC’s Failed Rollout of COVID-19 Tests Shows Federal Government’s Missteps and Miscalculations, Part One of Two

Previously unreported email messages and documents paint vivid picture of public health laboratory officials’ dismay and frustration over testing delays Between late January and early March, Clinical laboratory leaders watched with dismay as federal government...

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In the Field, Clinical Laboratory Specimen Transportation is Being Complicated by the COVID-19 Pandemic

Lab leaders who adopt best practices in courier services will help ensure their lab’s supply chains remain secure Hospital and health systems using courier services to transport patients’ biological specimens from doctors’ offices and other locations to clinical...

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Sean Penn’s Foundation Partners with Healthcare Providers in Four States to Offer Drive-Thru COVID-19 Molecular and Serological Clinical Laboratory Specimen Collections

Goal of his foundation is to provide access to COVID-19 medical laboratory tests for first responders, as well as low-cost tests to the general public Early in April, when many of the nation’s clinical laboratories were facing numerous challenges in their attempts to...

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UnitedHealthcare Announced It Would Cover Certain Pharmacogenomic Tests; However, Experts Hotly Debate the Value of Such Clinical Laboratory Testing

Though more payers are covering laboratory-developed genetic tests for conditions such as depression, the tests remain uncleared by the FDA Clinical pathologists interested in pharmacogenetics tests for depression and other psychiatric disorders may be interested to...

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Federal Government Is Sending Nearly $11 Billion to States for COVID-19 Clinical Laboratory Testing and Testing-Related Activities

Questions remain, however, over how much of the funding will actually reach hospital and health system clinical laboratories For many cash-strapped clinical laboratories in America, the second round of stimulus funds cannot come soon enough. Thus, lab leaders are...

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Harvard ‘Roadmap’ to Recovery Calls for ‘Massive’ Increase in Clinical Laboratory COVID-19 Testing in Four-Phase Blueprint for Reopening Economy

Report’s authors claim the US needs to be testing 20-million people per day in order to achieve ‘full pandemic resilience’ by August Medical laboratory scientists and clinical laboratory leaders know that the US’ inability to provide widespread diagnostic testing to...

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Health Insurers and Hospital Groups Argue Price Transparency Rules on Hospitals, Clinical Laboratories, and Other Providers Will Add Costs and ‘Confuse’ Consumers

Insurance industry claims new federal price transparency regulations cost each payer as much as $13.6 million in set up and maintenance costs Price transparency in hospital, clinical laboratory, and other service provider costs marches ever closer to reality for...

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Roche CEO Severin Schwan Questions the Ethics of Certain Companies Making COVID-19 Antibody Tests and Calls Some of These Clinical Laboratory Tests a ‘Disaster’

Schwan’s concerns about inaccurate or unreliable COVID-19 serology tests were supported when the FDA issued more restrictive rules for these medical laboratory tests on May 4 Last month, Roche Group CEO Severin Schwan characterized some COVID-19 antibody tests as a...

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Walmart Opens Second Health Center Offering Clinical Laboratory Tests and Primary Care Services

In another example of giving consumers more direct access to medical laboratory tests, Walmart believes that convenience and lower prices can help it capture market share Retail giants continue to add healthcare services—including medical laboratory testing—to their...

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With So Many New COVID-19 Serology Tests Obtaining EUAs from the FDA, How Can Clinical Laboratories Identify Tests That Should Perform Reliably?

As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own Every day, elected officials at all levels of government...

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Where Are the Patients? Hospitals and Clinical Laboratories Wonder When Routine Surgeries, Procedures, and Testing Can Be Restarted Once the COVID-19 Outbreak Eases

Even as some states lift stay-at-home orders, clinical laboratories and pathology groups face uncertainty about how quickly routine daily test referrals will return to normal, pre-pandemic levels Although strokes and heart attacks do not take vacations, a large and...

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Woman Who Can Smell Parkinson’s Disease in Patients Even Before Symptoms Appear May Help Researchers Develop New Clinical Laboratory Test

She worked with researchers at the University of Manchester in England to identify volatile biomarkers for Parkinson’s disease that may lead to first noninvasive screening Clinical pathologists and medical laboratories are used to working with certain biological...

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US Works with Clinical Laboratories to Launch Several Large-Scale COVID-19 Serological Surveys to Track Undetected COVID-19 in the Nation’s Population

Though some experts claim widespread antibody testing is key to effective public health safety, the WHO warns positive serological tests may not indicate immunity from reinfection or transmission of SARS-CoV-2 It may be the largest program of clinical laboratory...

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New CDC-led Genomics Consortium That Harnessed Genetic Sequencing to Track the SARS-CoV-2 Coronavirus includes Clinical Laboratories and IVD Firms

Medical laboratories are already using gene sequencing as part of a global effort to identify new variants of the coronavirus and their genetic ancestors Thanks to advances in genetic sequencing technology that enable medical laboratories to sequence organisms faster,...

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COVID-19 Pandemic Triggers Decline in Anatomic Pathology Testing and Shows How Digital Pathology, Remote Sign-Out Can Increase Pathology Services

Because of ‘shelter in place’ orders, many anatomic pathologists are reviewing digital images from home during the COVID-19 outbreak and demonstrating the value of whole slide imaging, digital pathology, and CMS’ recent amended remote sign-out policy COVID-19 is...

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UC Berkeley Creates COVID-19 Robotic Testing Laboratory in Record Time by Reallocating Equipment and Training Researchers to Do Clinical Analysis

Medical laboratory leaders may be inspired by this rapid start-up and its outreach to students and the Bay area In what could take a typical clinical laboratory months or even years to launch, the Innovative Genomics Institute (IGI) at the University of California,...

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COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse

Limited availability of COVID-19 clinical lab tests is major topic at federal briefings and news stories, yet many of nation’s labs are laying off staff and at point of closing Cash flow at the nation’s clinical laboratories has crashed, with revenues down by more...

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COVID-19 Disruptions of Supply Chains Are One More Challenge for Clinical Laboratories to Bring Value to Hospitals and Healthcare Networks

Supply chain experts can explain ways clinical laboratories should evaluate their suppliers and sources Suddenly, supply chain management has become a critical success factor as hospitals, health systems, and clinical laboratories throughout the United States respond...

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FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public

Though the potential is high for false positives and false negatives, some experts believe at-home COVID-19 testing still holds promise for slowing the spread of the coronavirus Laboratory Corporation of America (LabCorp) is the first diagnostic test developer to...

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In New Hampshire, Cooperation Was Key to Handling Clinical Laboratory Testing Challenges Posed by the COVID-19 Outbreak

Facing a backlog, the state’s public health laboratory turned to the medical laboratory at Dartmouth Hitchcock Medical Center Much of the attention surrounding the COVID-19 outbreak—the illness caused by the SARS-CoV-2 coronavirus—has focused on large urban areas such...

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Tech Companies Suggest Ways Location Tracking Could Help Health Authorities Fight the COVID-19 Coronavirus by Identifying People Who May Need Clinical Laboratory Testing

Privacy concerns have one tech giant suggesting alternatives to sharing potentially identifiable location tracking data Expect an interesting debate on the use of location tracking as a way to manage this and future pandemics. It is a debate that has implications for...

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Drive-Through Coronavirus Testing Spreads across 30 States, Lowering Risk of Exposure to Phlebotomists and Clinical Laboratory Professionals

Prior to the SARS-CoV-2 pandemic, large-scale collection of medical laboratory specimens from patients sitting in their cars was an untried concept. That is no longer true. As of today, residents who meet certain criteria for exposure to SARS-CoV-2—the novel...

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