Federal Prosecutors Add a 12th Felony Fraud Charge in Latest Criminal Indictment Against Theranos Founder Elizabeth Holmes

Holmes’ lawyers maintain the former CEO of Theranos has not waived right to be charged by indictment and therefore argue the added charge is ‘unconstitutional’ and should be dismissed Clinical laboratory leaders needing a break from nonstop coronavirus pandemic news...

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Two Florida Clinical Laboratory COVID-19 Test Contracts Come Under Scrutiny

One medical testing company was led by a convicted felon, another was accused of delays and unreliable results Like many states, Florida has worked hard to quickly ramp up diagnostic testing for SARS-CoV-2, the coronavirus that causes the COVID-19 illness. For the...

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New Gene Sequencing Method for Studying Circular DNA Found in Viruses, Bacteria, and other Cells, May Lead to Development of New Clinical Laboratory Biomarkers

University of Alberta researchers developed CIDER-Seq tool and protocols for the study, which they have made freely available to all scientists Here’s another promising new technology which, given more research into effectiveness and safety, may soon lead to improved...

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Australia Spent $200 Million (AUD) on Chinese COVID-19 Diagnostic Testing Kits That Went into The Country’s Strategic Reserve Rather than Being Used

Australian government heralded April purchase of 10 million clinical laboratory diagnostics tests from BGI, but most of the nation’s states and territories say kits are unneeded or unable to be used by their health departments While the United States and other nations...

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Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests

In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by...

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FTC Orders Hospital, Health System, and Five Insurers in Two States to Share Vast Amounts of Data on Their Customers and on Past Acquisitions and Mergers

Lab leaders may recall similar requests for data from other government agencies and wonder if FTC will take steps to investigate pricing and competition among clinical laboratories as well It appears that the Federal Trade Commission (FTC) is ready to look into...

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Molecular Testing for Urinary Tract Infection (UTI): 2020 Update on Clinical Utility and Reimbursement Trends

Molecular tests are becoming more routine as diagnostic tools, with many now covered by Medicare and commercial insurers. Advantages of molecular tests based on PCR technology include their ability to identify uropathogens traditionally missed by culture-based tests.

Driven by urgent, unmet analytical and clinical care needs, the adoption of the rapid molecular test—particularly RT-PCR for urinary tract infection control and treatment—has important implications.

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Medical Laboratory Test Data and Clinical Lab 2.0 are Powering Dashboards That Help Providers Mitigate COVID-19 and Improve Population Health

Coronavirus informatics companies are drawing clinical laboratory test data out of the shadows and into the light and compiling it into critical bioinformatics resources What better example do we have that clinical laboratory test data is critical to population health...

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Case Studies in Clinical Laboratory Test Stewardship: The Financial and Clinical Impact of Clinical Decision Support in Hospital Laboratories

This white paper – the third in a three-part series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare – provides frontline perspective and commentary from experts and physicians on the application and value of decision support in the laboratory. It also includes early-adopter proof points from hospital laboratories that have successfully implemented third-party decision support to achieve their stewardship goals, including EHR interventions and ongoing monitoring of utilization.

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Translating Clinical Laboratory Science Into Business Objectives: How an Educational Program Measured and Analyzed Performance and Transformed the Approach to Improving Laboratory Operations

Now more than ever before, clinical labs are under pressure to operate efficiently, accurately, and timely, all while still making money. Doctors and patients have come to expect a 24-hour turnaround for most tests. Clinical labs throughout the United States have been slashing budgets, many literally to the point of no return. At least 13 public health labs in four states have shuttered since 2003, which posed a serious problem when COVID-19 hit because resources did not meet demand.

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FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA)...

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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

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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