With the ability to access critical biomarkers through the skin, this innovative patch from Georgetown researchers could shift the standard of care in diagnostics and drug delivery.
Researchers at Georgetown University have developed a technology that may replace the need for traditional blood testing: a non-invasive transdermal patch can detect biomarkers found in the bloodstream without drawing blood or inserting any devices into the body. The patch contains microheaters that reach 100 degrees Celsius to collect interstitial fluid from the surface of the skin.
Interstitial fluid is the vital liquid located in the spaces surrounding cells that transport oxygen and nutrients to cells throughout the human body, while removing waste products. The origin of this fluid is derived from blood plasma that leaks out of blood capillaries and eventually moves back into the bloodstream via the lymphatic system.
“The interstitial fluid, sometimes also called extracellular fluid, bathes every living cell in your body,” stated Makarand Paranjape, PhD, associate professor of physics and director of the Georgetown Nanoscience and Microfabrication Cleanroom Lab (GNuLab) in the College of Arts & Sciences in a news release. “It’s like a pre-filtered sample. When you draw blood, you have to filter down all the other stuff you don’t need. We don’t have to do that, so the interstitial fluid is ideal for detecting blood-borne biomarkers or biomolecules.”
The project originally began 25 years ago and was funded by the Department of Defense.
Over the past two decades, Paranjape has advanced this biomedical technology and built a portfolio of patents through Georgetown’s Office of Technology Commercialization, aiming to improve the quality of life for patients living with a broad range of chronic diseases.
Paranjape believes his patch, which he compares to a Band-Aid, will be beneficial for people who must have regular blood draws for disease maintenance and control, such as patients with diabetes, cancer, or heart disease.
Paranjape’s patch technology uses flexible polymers on an adhesive base, incorporating gold microheaters to create tiny pores in the skin, enabling the collection of interstitial fluid.
“You’re inserting a needle into your arm or abdomen and putting a sensor inside the body to detect blood glucose. Anytime you put something in your body, it’s going to be attacked by your own immune system,” he said.
Makarand Paranjape, PhD, associate professor of physics and director of the Georgetown Nanoscience and Microfabrication Cleanroom Lab (GNuLab) in the College of Arts & Sciences said, “When you’re talking about drug delivery and even monitoring biomolecules for diabetes, it’s all about the quality of life. Can that be improved? This technology, I feel, will do that.” (Photo credit: Georgetown University.)
Once the microheaters have been activated, the interstitial fluid exudes naturally from the pores in the skin and the patch is able to monitor biomarkers in the bloodstream. Because the temperatures applied to the skin and the generated micropores are shallow and do not reach nerve endings, the patch is pain-free. Patients also only need to change the patch once a day.
“That highly-controlled thermal pulse effectively removes only a microscopic portion of the top-most layer of dead skin. It’s essentially exfoliating that small area of skin to an extent that you’re creating a hair-sized micropore from the top of the skin extending to the living tissue,” Paranjape affirmed. “Once you get through that layer, there is plenty of interstitial fluid that actually comes up and out of the micropore since your heartbeat is providing pressure.”
Potential Beyond Diagnostics: A New Frontier for Drug Delivery
Paranjape developed the patch primarily with diabetics in mind but is hoping his device has further uses, including drug delivery. Transdermal patches for time-released drug delivery are available, yet this patch, according to Paranjape, is more effective as current patches on the market require existing drugs to be modified.
“Most of these patches require the drug in question to be tailored chemically to allow it to penetrate through intact skin. Ours does not,” he asserted. “We can use off-the-shelf drugs. We are creating tiny pores through the skin so the drug can easily enter and diffuse to the circulatory system.”
Paranjape also theorizes the patch could reduce pharmaceutical dosages, diminish medical waste and help curtail healthcare costs. His lab is currently working on adopting the patch for drug delivery in patients with Parkinson’s disease. He also plans to start a drug trial soon to help diagnose patients with cystic fibrosis.
Paranjape is hopeful that his patch-based platform technology will be utilized in the future to diagnose and treat patients with a wide array of illnesses and improve their quality of life.
“If there’s a marker in the blood that can be detected in the interstitial fluid, you can use the patch. If there’s a drug that can be used for the treatment of a condition, you can use the patch,” he said. “There’s a whole host of conditions that can be treated.”
Roche’s IVDR-certified Elecsys pTau181 blood test helps rule out Alzheimer’s early, supporting faster decisions in primary care.
Roche has received CE Mark approval for its Elecsys pTau181 test, developed in collaboration with Eli Lilly. The test measures phosphorylated Tau 181 (pTau181), a biomarker associated with amyloid pathology—one of the hallmarks of Alzheimer’s disease. Clinicians can use this test alongside other clinical data to help rule out Alzheimer’s as the cause of cognitive decline, potentially reducing the need for further diagnostic procedures in patients who test negative.
This is a minimally invasive blood test and was shown to be effective in clinical care settings such as primary care offices. The news is the latest in a series of breakthroughs in Alzheimer’s detection. This past June, The Dark Daily reported two of these stories:
This latest development from the Swiss-based company further shows how these developments are happening on a large and international scale. This also marks the second collaboration of Roche and American-based Eli Lilly on an Alzheimer’s biomarker test. As stated by Fierce Biotech, a 2023 breakthrough was a ‘side quest’ in Eli Lilly’s ongoing crusade against Alzheimer’s disease.
Removing Barriers to Care
As stated in the press release, up to 75% of individuals who live with symptoms of Alzheimer’s disease are never diagnosed. The ones who are diagnosed wait an average of approximately three years to seek testing after they experience an onset of symptoms.
“The burden of Alzheimer’s disease on society and healthcare systems is increasing as the world’s population ages,” said Matt Sause, CEO of Roche Diagnostics.
“With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide,” Sause noted.
First of its Kind
According to Roche, this approval is the first of its kind for a blood test that rules out Alzheimer’s disease. This international study included 787 patients. The press release also stated, “The study showed the test was able to rule out Alzheimer’s disease with a high negative predictive value (NPV) of 93.8% based on a 22.5% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 83.6% sensitivity.”
This global study’s uniqueness came from the recruitment of a diverse patient pool that was specifically designed to reflect the patients who could benefit the most from this kind of testing.
Great Strides in Alzheimer’s Research
This news follows other key developments in detection and treatment of Alzheimer’s disease. Roche also reported success with a new Alzheimer’s drug. Trontinemab, an antibody drug, performed well in clinical trials with 91% of participants showing almost complete amyloid plaque removal according to Gene Online. Roche will now go onto two large scale clinical trials for 2025 to further test the effectiveness of the drug.
With these advances in testing and treatment of Alzheimer’s disease, pathology professionals would be wise to keep on the pulse of the news. About 75% of people living with Alzheimer’s disease globally remain undiagnosed according to the Gene Online reporting––in the coming years we could see that number dramatically go down.
With recruitment pressures mounting, national pathology societies are aligning on a unified approach that could benefit both applicants and clinical lab leadership.
Laboratory leaders play a central role in shaping the future pathology workforce—not only through daily operations and training, but by supporting broader efforts that impact recruitment, equity, and retention across the field. As workforce challenges continue to affect many institutions, a new joint statement from the College of American Pathologists (CAP) and 12 other national pathology organizations highlights an important step forward: standardizing the fellowship recruitment process across subspecialties.
“Our residents and fellows deserve a recruitment process that puts their needs first,” said CAP President Donald S. Karcher, MD, FCAP.
“By supporting this match effort, we’re advancing fairness, transparency, and a more unified future for our profession,” noted Donald S. Karcher, MD, FCAP. (Photo copyright: GW Cancer Center.)
Spearheaded by the Association for Academic Pathology (AAPath) Fellowship Directors Committee, the joint statement recommends participation in the 2027 match cycle, placing fellows into programs for the 2028–29 academic year. Several subspecialties—including Hematopathology, Molecular Genetic Pathology, and Forensic Pathology—have already committed to joining by the 2026–27 cycle.
Future Workforce Planning
For clinical lab leaders involved in workforce planning, aligning recruitment timelines may offer benefits such as improved coordination, greater equity for applicants, and a more structured approach to fellow selection. Survey data cited in the joint statement indicate that “a substantial majority (~85%) of trainees desire a standardized timeline for fellowship recruitment,” with a similar percentage of program directors supporting broader interview opportunities before applicants make decisions.
Additionally, programs that bypass a coordinated process “are discouraged from asking for a commitment from any applicant before the common date chosen by the subspecialty”—a recommendation designed to curb early-offer dynamics that “harm, or perceive harm,” to programs aligned with the common timeline.
CAP emphasizes that this move is part of its larger workforce strategy. “This initiative builds on its broader advocacy to improve training, recruitment, and retention across the specialty,” the organization stated.
Given ongoing concerns about trainee experience and consistency across programs, clinical laboratory leaders may be encouraged to support efforts that promote fair and sustainable fellowship recruitment practices across pathology subspecialties.
Recent laws in California, Utah, and Texas define new compliance standards for clinical laboratories employing AI in diagnostic and clinical messaging.
When it comes to oversight of artificial intelligence (AI) use in clinical laboratory, it behooves lab leaders to watch what is happening on the state level. In some cases, disclosure of AI use is a threshold states are monitoring.
For example, California Assembly Bill 3030, which went into effect Jan. 1, 2025, mandates transparency when generative AI is used in healthcare. Any health facility, laboratory, clinic, physician’s office, or group practice that employs generative AI to create patient communications about clinical information must include:
A prominent disclaimer stating the content was AI-generated.
Clear instructions that inform patients how to speak directly with a human clinician.
If a licensed provider reviews and approves the AI-generated communication, these requirements are waived. AB 3030 applies only to clinical—not administrative—messages. Non‑compliance can result in disciplinary actions from state regulators.
Laboratories using AI in patient-facing contexts should ensure their workflows include AI‑disclaimers, human‑review triggers, and clear ways for patients to contact providers.
“Symposium Cisco Ecole Polytechnique 9-10 April 2018 Artificial Intelligence & Cybersecurity” by Ecole polytechnique / Paris / France is licensed under CC BY-SA 2.0.
AI Disclosure in Utah
Meanwhile, Utah Senate Bill 226 updates its Artificial Intelligence Policy Act, tightening rules around how healthcare entities—including clinical labs—use generative AI in patient interactions. The rules went into effect May 7, 2025.
Under the state’s law, labs must disclose AI use only when:
A patient explicitly asks whether they’re interacting with AI, or
The lab uses AI in high-risk communications, such as delivering test interpretations, diagnostic results, or clinical advice.
Routine AI use in back-end operations or non-clinical messaging does not require disclosure.
A safe harbor provision protects labs from penalties if the AI system clearly identifies itself as non-human at the beginning and throughout the interaction.
Labs that use AI-generated content in patient portals, chatbots, or outreach must ensure compliance or face consumer protection penalties.
New Texas Law on AI
Texas passed a law in June that goes into effect Sept. 1, 2025, the regulates how AI is used within electronic health records (EHRs).
According to the law, providers that use AI for recommendations on diagnosis or treatment based on a patient’s medical record must review all information obtained through AI to ensure its accuracy before entering the information into a patient’s EHR.
The law also “imposes a strict data localization mandate, prohibiting the physical offshoring of electronic medical records,” law firm Holland & Knight noted. “This requirement applies not only to records stored directly by healthcare providers but also to those maintained by third-party vendors or cloud service providers.”
Published in “Nature Genetics,” the global study finds a strong link between FOXP4 expression and long COVID, offering new hope for diagnostic development.
A global study has uncovered genetic variants linked to an increased risk of long COVID, marking an important step toward understanding the biology of the condition and laying early groundwork for future diagnostic tools.
The recent study, “Genome-wide association study of long COVID,” is published in Nature Genetics, and it identified a significant genetic association between long COVID and variants in the FOXP4 gene, which is known to influence lung function. Higher levels of FOXP4 expression were found in individuals with long COVID, and the risk associated with these variants was consistent across different ancestry groups. This supports the idea that lung-related immune responses play a major role in long COVID, though the condition also involves a wide range of symptoms such as fatigue and cognitive dysfunction.
Future Diagnostic Advancements
For laboratory professionals, the findings from this large-scale genetic study on long COVID represent an important step toward future diagnostic innovation grounded in molecular evidence. While the identified FOXP4 variants and associated immune-lung pathways are not yet predictive at the individual level, they offer valuable insight into the underlying biology of long COVID—insight that can inform the development of biomarker assays and future diagnostic tools. As research advances, lab teams will be essential in validating and implementing potential biomarkers, integrating genetic and proteomic data into routine workflows, and supporting interdisciplinary efforts to transition these discoveries from bench to bedside. Though clinically actionable tests may still be years away, the study underscores the evolving role of the clinical lab in decoding complex, post-viral syndromes through precision diagnostics and collaborative research.
Conducted by the Long COVID Host Genetics Initiative, the study analyzed data from 33 independent studies across 19 countries, involving nearly 16,000 individuals diagnosed with long COVID and about 1.9 million control participants. The research included diverse populations across six genetic ancestries, making it one of the most comprehensive efforts to date using a genome-wide association study (GWAS) approach.
Today’s Clinical Lab reported in 2024 that “As early as spring 2020, people who had survived COVID-19 began publicly sharing their ongoing symptoms and struggles to recover. Originally driven almost entirely by patients, researchers and clinicians eventually responded to the push to investigate these reports, ultimately publishing a study showing that only one in eight participants were symptom-free two months after infection. From that point, research into the post-viral condition, popularly termed ‘long COVID,’ accelerated—from 105 articles published on the topic in 2020 to nearly 5,000 in 2023.”
Studies Continue
In addition to identifying genetic risk factors, the researchers established a causal link between SARS-CoV-2 infection and the development of long COVID, particularly in cases involving severe illness that required hospitalization. The study also explored the overlap between long COVID-associated variants and those related to other diseases, suggesting that both genetic predisposition and environmental factors contribute to the risk of developing long COVID.
Hanna Ollila, PhD, a co-author of the study from the Institute for Molecular Medicine Finland and Massachusetts General Hospital, said, “The findings from our study, and from genome-wide association studies in general, tell about biological mechanisms behind a disease. This can then help to understand the disease better. For example, is it a disease neuronal, immune, metabolic, and so on?”
She also explained that developing a diagnostic test from these findings will take time, as the genetic variants identified don’t have the strong, direct impact seen in mutations like BRCA in breast cancer.
“In other words, they do not strongly predict whether someone will develop long COVID at the individual level. Instead, they highlight the biological systems involved in the disease. In this case, our findings point to immune pathways related to lung function,” Ollila noted.
The researchers reported that as larger sample sizes become available in future studies, the accuracy and depth of genetic analyses will improve. This could help scientists more clearly define the biological underpinnings of long COVID and identify specific biomarkers for diagnosis. Despite the progress made, Ollila commented it could still take a decade or more to develop clinically useful diagnostic tools based on these genetic insights.
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 a more complex reimbursement landscape.
According to an article from The Associated Press, on July 24, UnitedHealth Group, the largest U.S. provider of Medicare Advantage (MA) plans, revealed in a Securities and Exchange Commission (SEC) filing that it is now cooperating with both criminal and civil investigations by the Department of Justice (DOJ). The probes are centered on allegations that the company inflated patient diagnoses in order to receive larger payments from the federal government. These investigations, which were first surfaced in reports by The Wall Street Journal earlier this year, are now confirmed.
UnitedHealth Comments on Investigation
UnitedHealth said it initiated contact with the DOJ after the reports came to light and is already responding to information requests. The company also announced it has launched a third-party review of its business policies and performance metrics, which is expected to conclude by the end of the third quarter, according to comments made to CNBC.
“UnitedHealth has full confidence in its practices and is committed to working cooperatively with the Department throughout this process,” the company stated in its filing.
The DOJ’s criminal investigation reportedly includes interviews with doctors about whether they were pressured to submit claims for certain diagnoses that would lead to higher MA payments. A civil inquiry into the company’s billing practices has been underway since February. Both investigations center around suspicions that UnitedHealth used retrospective chart reviews and in-home health assessments—often carried out by clinicians contracted through its Optum unit—to bolster patient risk scores and inflate payments from Medicare.
What this Might Mean for Clinical Labs
Clinical laboratories may be affected, as lab-generated diagnostic data is frequently used to support or validate the conditions coded for reimbursement. If regulators demand greater transparency or auditing of how diagnostic data is linked to MA billing, labs could face increased scrutiny on test utilization, data accuracy, and coding practices.
CNBC reported that UnitedHealth has pushed back against some of the scrutiny. The company noted that Centers for Medicare & Medicaid Services (CMS) audits have found its practices to be “among the most accurate in the industry.” It also cited a special master’s recommendation in March in an ongoing legal case stemming from a whistleblower complaint that accused the company of withholding $2 billion in Medicare payments. In that case, the special master concluded that the DOJ had insufficient evidence to proceed.
As for the timing of the DOJ confirmation, UnitedHealth has had a challenging year. The company has endured stock volatility, leadership upheaval, and broader reputational risks. In May, CEO Andrew Witty abruptly resigned, and earlier in the year, the firm dealt with the fatal shooting of UnitedHealthcare CEO Brian Thompson in New York City. UnitedHealth is also still recovering from a massive cyberattack that disrupted operations across its network.
“This all sounds logical as it moves forward with a new CEO,” wrote Jared Holz, healthcare strategist at Mizuho Securities, in a note to clients July 24, while noting that UnitedHealth had previously denied being under federal investigation.
Jared Holz, Mizuho healthcare sector strategist, said UnitedHealth’s choice to acknowledge the probes and cooperate with the department “all sounds logical as it moves forward with a new CEO.”
The Medicare and Retirement division, which includes the Medicare Advantage business, brought in $139 billion in revenue last year, making it UnitedHealth Group’s largest segment. But medical costs have surged, particularly among new MA enrollees. UnitedHealth suspended its 2025 forecast and withdrew guidance altogether in May due to financial uncertainty.
For clinical labs, payers, and providers, the situation underscores a growing federal focus on Medicare Advantage oversight, potentially reshaping not only billing practices but also the data and diagnostics behind them.
