The Dark Report

08/06/2025

UnitedHealth Faces DOJ Probes

Federal investigations into UnitedHealth’s Medicare billing could impact clinical labs and reshape diagnostic workflows.

The intensifying federal investigation into UnitedHealth Group’s Medicare Advantage billing practices is making headlines in both major outlets and industry-specific trade publications. Clinical laboratories have the potential to soon feel the effects. As questions grow around how the insurance giant gathers and codes medical diagnoses, labs that play a role in confirming those diagnoses could see heightened regulatory oversight, increased documentation requirements, and...

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08/04/2025

Every UK Newborn to Have DNA Fully Sequenced from Umbilical Cord Blood

The NHS plans to map the DNA of all newborns in England over the next 10 years to evaluate their risk for hundreds of diseases

Clinical laboratories in the UK will soon see a new increase for specialized testing. Under a new 10-year plan by England’s National Health Service (NHS), every newborn baby in the country will have their complete DNA mapped using tiny blood samples taken from their umbilical cords shortly after birth. The blood samples will assess an infant’s risk for hundreds of diseases with the intent of...

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08/01/2025

Using Sophisticated Schemes, Fraudsters Hit the Next Level
However, federal investigators have proven worthy adversaries, fighting back with bulked-up coordination

Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history.

Clinical laboratory leaders will observe that while the sophistication of the criminals is breathtaking at times—in one scheme, the alleged perpetrators used artificial intelligence (AI) to create fake voice recordings of beneficiaries—the coordination among federal law enforcement agencies in response seems unprecedented.

After a two-year investigation, the 2025 National Health Care Fraud Takedown resulted in criminal charges being levied against...

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Discover how sophisticated schemes by fraudsters are evolving, while federal investigators ramp up efforts to combat Medicare fraud in historic takedowns.

08/01/2025

Study: Deaths from Non-Communicable Diseases on the Rise in the Americas

The Pan American Health Organization has sounded the alarm: non-communicable diseases have surged with relentless force over the past 25 years, painting a grim portrait of a mounting public health crisis.

Non-communicable disease (NCD) deaths have risen by an alarming 43% in the Americas during the last 25 years, according to a recent report released in July by the Pan American Health Organization (PAHO).

A Silent Epidemic: Non-Communicable Diseases Surge Across the Americas

In 2021, NCDs were responsible for 65% of all deaths in the region or 9.2 million people. Almost 40% of these deaths occurred before...

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07/30/2025

The team is on-site at ADLM 2025. It has been a dynamic few days exploring the future of clinical diagnostics, connecting with industry leaders, and gathering insights to shape our upcoming coverage.

The team will be reporting on key takeaways soon, so be sure to watch for our upcoming issues of The Dark Report and Today's Clinical Lab!

Association for Diagnostics & Laboratory Medicine

07/30/2025

UK Scientists Link Repeated Miscarriages to Defect in Womb Lining, Develop New Diagnostic Test

UK researchers have identified a link between womb lining issues and recurrent miscarriage, leading to a new test that may help detect risks before pregnancy.

Researchers in the UK have identified a malfunction in the womb lining as a significant contributor to recurrent miscarriages—even when embryos are healthy. The new study entitled “Stalling of the Endometrial Decidual Reaction Determines the Recurrence Risk of Miscarriage,” was published June 25 in the journal Science Advances. The scientists’ findings have led to the development of a new diagnostic tool aimed at identifying women

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07/28/2025

King’s College London Scientists Develop Painless Nanoneedle Patch
Lead author of a new study, Ciro Chiappini, PhD, says this new technology could lead to advancements in personalized medicine

Scientists at King’s College London have developed a nanoneedle patch that offers a painless alternative to biopsies that also delivers quicker and more accurate results.

As reported by Phys Org, new research published in Nature Nanotechnology shows that these new patches could be the future of diagnostics. As common as traditional biopsies are, they can be painful and often patients are...

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07/25/2025

Johns Hopkins Researchers Develop Blood Test That Detects Cancer Years before Symptoms Occur

Promising results showcase benefits of MCED lab tests and provide hope for continued advancements

In impressive new research, Johns Hopkins School of Medicine has developed a clinical laboratory blood test that detects the presence of cancer years before symptoms present, aiding physicians with early diagnosis and treatment.

The identification of cancer cells comes via bloodstream analysis showing genetic materials shed by tumors and showcases the promise of multicancer...

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07/24/2025

Lab Stakeholders Discuss PAMA Reform
Washington insiders contend that 2025 may be a pivotal year for clinical laboratories to speak up

With President Donald Trump’s administration cementing its power in Washington, what’s the likelihood of policy changes that will benefit clinical laboratories?

Labs scored one victory when the Trump administration declined to appeal a federal court ruling, in a lawsuit brought by the American Clinical Laboratory Association (ACLA), that vacated the Food and Drug Administration’s (FDA) final rule on laboratory developed tests. But prospects are not so clear for another big item on the lab industry’s wish list: reforms to the Protecting Access to Medicare Act (PAMA).

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As PAMA reimbursement cuts loom, medical labs face challenges. Discover why laboratory associations advocate for lasting reforms over short-term solutions.

07/24/2025

Now On Demand! "Transforming Bacteremia Care with Rapid AST — Real-World Insights from a Prestigious Reference Lab," is an essential webinar exploring how rapid antimicrobial susceptibility testing (ASTar) is transforming patient care. In this webinar, Vittal Prakash Ponraj, Ph.D., SM(ASCP)CM, Technical Director of Hospital Microbiology at Quest Diagnostics, presented findings from a real-world evaluation of an FDA-cleared, high-throughput AST platform that delivers results without sample pre-processing. Using clinical specimens from two hospitals, Dr. Ponraj shared valuable insights into how ASTar can reduce time-to-therapy, lower healthcare costs, and support more confident decision-making.

To learn more about this webinar and to watch now, visit Dark Daily webinars!

Join this insightful webinar to explore how rapid AST (rAST) can transform infectious disease management—improving patient care while optimizing lab efficiency.

07/23/2025

The latest issue of The Dark Report is now available — bringing you expert analysis, timely updates, and industry intelligence you won’t want to miss. Whether you're navigating lab management, regulatory strategy, or emerging diagnostics, this edition delivers impactful content tailored for today’s clinical leaders.

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07/23/2025

New Blood Test Helps Physicians Diagnose Rare Genetic Diseases in Infants Using Just a Small Drop of Blood

Researchers expect their test to reduce diagnostic time in clinical settings and help identify carriers of the diseases

Clinical laboratories have always been at the forefront of helping families battle rare diseases. But such testing is sometimes invasive and expensive. Now there’s a new blood test that is minimally invasive and rapidly detects thousands of rare genetic diseases in infants and children using a mere 1ml of blood.

Developed at the University of Melbourne and Murdoch Children’s Research Institute in Australia, the test rapidly detects abnormalities using proteomics to simultaneously analyze the pathogenicity of thousands of gene mutations that cause rare genetic...

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