Findings could reduce the need for self-reporting in future nutritional studies and lead to new clinical laboratory testing
Clinical laboratory testing may one day influence whether a person snacks on a bag of chips every day or chooses to eat healthy foods instead.
Researchers at the National Institutes of Health (NIH) reported that they have identified biomarkers in blood and urine that can indicate an individual’s consumption of ultra-processed foods (UPF).
Scientists discovered a signature that is predictive of a dietary pattern that’s high in ultra-processed food, study leader Erikka Loftfield, PhD, MPH, epidemiologist and principal investigator with the NIH, told the Associated Press (AP).
Using data on the biomarkers—metabolites left after the body breaks down food—the researchers devised a “poly-metabolite score” that could potentially “reduce the reliance on, or complement the use of, self-reported dietary data in large population studies,” according to an NIH press release.
This will be helpful because, according to the AP, “Typical nutrition studies rely on recall: asking people what they ate during a certain period. But such reports are notoriously unreliable because people don’t remember everything they ate, or they record it inaccurately.”
“Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said Loftfield in the press release.
Thus, it’s conceivable that one day clinical laboratory testing could affect people’s food choices and help to improve their health.
“There’s a need for both a more objective measure and potentially also a more accurate measure,” Erikka Loftfield, PhD, MPH, epidemiologist and principal investigator with the NIH, told the Associated Press. (Photo copyright: National Cancer Institute.)
Study Methodology
The findings were based in part on an earlier study of 718 AARP members, aged 50-74, who agreed to submit blood and urine samples. The participants also completed dietary recall reports.
“The researchers found hundreds of metabolites that correlated with the percentage of energy from ultra-processed foods in the diet,” the NIH press release noted. “Using machine learning, researchers identified metabolic patterns associated with high intake of ultra-processed foods and calculated poly-metabolite scores for blood and urine separately.”
To test their findings, the researchers referred to a 2019 NIH study involving 20 adults aged 18 to 50. Under carefully controlled conditions, these participants spent two weeks consuming high levels of ultra-processed foods, followed by two weeks consuming no ultra-processed foods. As with the AARP cohort, they also submitted blood and urine samples. The poly-metabolite score proved to be an accurate measure of which diets they had consumed, the researchers reported.
The researchers acknowledged limitations in the study that will necessitate further research. “Study participants were older US adults whose diets may vary from other populations,” the authors noted. “Poly-metabolite scores should be evaluated and iteratively improved in populations with diverse diets and a wide range of UPF intake.”
Ultra-Processed Foods Defined
The NIH defines ultra-processed foods as “ready-to-eat or ready-to-heat, industrially manufactured products, typically high in calories and low in essential nutrients.” Diets high in these foods have been associated with “increased risk of obesity and related chronic diseases, including some types of cancer,” the press release noted.
In identifying these foods, the researchers cited a 2019 paper published in the journal Public Health Nutrition (PHN). The paper relied on the NOVA classification system, which makes a distinction between “processed” and “ultra-processed” foods. The latter typically contain “food substances never or rarely used in kitchens,” or cosmetic additives “whose function is to make the final product palatable or more appealing,” the PHN paper noted.
“From sugary cereals at breakfast to frozen pizzas at dinner, plus in-between snacks of potato chips, sodas and ice cream, ultra-processed foods make up about 60% of the US diet,” the AP reported in an earlier story. “For kids and teens, it’s even higher—about two-thirds of what they eat.”
Diagnostic laboratories must dig into where their suppliers source their items to avoid surprises
Clinical laboratories in the US are under additional financial and operational pressure because of tariff fluctuations from the federal government among global trading partners. This brief overview explores clinical lab tariff strategies that may help organizations better prepare for difficult stretches.
Across the overall laboratory industry—including diagnostics settings—average duties on imported lab equipment and consumables hover around 23%, with personal protective equipment, lab instruments, and supply chains facing even higher tariffs depending on their origin, according to a report from Lab Manager, a sibling brand to Dark Daily.
“Don’t assume that just because something is made in the United States that it will be tariff free because many of the components are not,” Drew Kevorkian, founder and CEO at ARES Scientific, told Lab Manager. ARES Scientific maintains a useful online tariff guide.
These nuances can escalate costs, complicate budgeting, and squeeze margins, all of which pose a risk to financial viability for clinical labs.
When it comes to clinical lab tariff strategies, the starting point is clear. “Assume costs are going up one way or another. The best thing to do is be well informed,” Drew Kevorkian, founder and CEO at ARES Scientific, told Lab Manager. (Photo copyright: Ares Scientific.)
Tariff-Influenced Areas for Clinical Labs to Consider
Managers and others who oversee budgeting or product procurement should think about the following aspects as they plan out their clinical lab tariff strategies:
Component audits. Labs should undertake an audit of their consumables down to the stock-keeping unit (SKU), which is an alphanumeric descriptor that identifies a product. The goal is to identify the source of the products to determine if they come from tariff-affected countries, Kevorkian noted. This exercise allows clinical lab professionals to forecast cost scenarios and make informed procurement decisions.
Reused lab instruments. Tariffs introduce an opportunity to think about acquiring certified refurbished lab equipment. Such items, often already in the US, can offer meaningful savings and avoid import duties, according to Lab Manager.
Investigate in vitro diagnostics (IVD) sourcing. Clinical labs should look into where their IVD suppliers get their components, according to The Dark Report. Even if a lab buys from American-based suppliers, the IVD companies a laboratory works with might have ties overseas that aren’t immediately obvious. “All IVD companies get components from China,” Rob LaCroix, executive director of global strategy at LTC LLC, told attendees at the 2025 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. “Just-in-time [purchasing] with tariffs is a problem,” he noted.
Clinical Lab Tariff Strategies Should Model Various Budget Scenarios
Lab Manager suggested that laboratories build tiered budget models that consider various tariff scenarios:
Baseline case assumes stable tariffs (around 23% as noted earlier).
Worst case simulates escalation or new restrictions.
Optimistic case explores tariff relief or exemptions.
These forecast ranges enable clinical labs to develop contingency plans, such as temporarily reducing discretionary spending or exploring ways to pass on incremental costs.
Hospital laboratories are likely to see an increase in test orders for bacteria-borne infections, such as tuberculosis
The tuberculosis outbreak in Kansas City, Kan., is one of the largest in the US within a one-year period over the past several decades. Hospital laboratories are the front line for detecting these types of infectious diseases.
As of June 6, 2025, the number of reported active cases of tuberculosis (TB) since 2024 was 69 with 62 cases in Wyandotte County and seven cases in nearby Johnson County, both in Kansas, according to the latest available data as of this writing from the Kansas Department of Health and Environment.
An active TB infection is one in which patients are symptomatic, in need of immediate treatment, and contagious. These patients have typically had a positive TB blood or skin test and may have had an abnormal chest x-ray or positive sputum smear or culture.
The latest statistics show there are 97 cases of latent TB infections reported in the same counties. Latent TB infections are those where patients are asymptomatic but have had a positive TB test, a normal chest x-ray, and a negative sputum smear.
Although individuals with latent infections cannot transmit the illness to others, these cases may become active without treatment, rendering them potentially dangerous.
“You can think of TB outbreaks like a canary in the coalmine of our public health infrastructure,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “What causes them to happen is a weakening of our public health infrastructure.” (Photo copyright: Johns Hopkins Medicine.)
Cause of Outbreak Remains Unknown
This TB outbreak was first identified in Kansas last year and its origin is unknown. Two people have died from the infection, but the risk to the public remains low.
“It’s definitely more than just a little blip,” David Dowdy, MD, PhD, professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, told The Guardian. “It’s one of the largest outbreaks of tuberculosis that we’ve seen in the country in the past 30, 40, 50 years.”
TB in humans can be caused by two types of mycobacteria: Mycobacterium tuberculosis and Mycobacterium bovis. The former is the most common cause of the disease. The pathogen is airborne and is transmitted via respiratory droplets produced by coughing, sneezing, or speaking.
TB usually attacks the lungs, but other parts of the body can be affected as well. According to the Centers for Disease Control and Prevention, symptoms of the disease include:
Cough that lasts more than three weeks.
Coughing up blood or sputum.
Fever and chills.
Loss of appetite.
Weight loss.
Night sweats.
Weakness or fatigue.
Chest pains.
Each patient in the Kansas outbreak has been screened and contact traced. Testing is being provided free of charge. TB is treatable via antibiotics, and more than 85% of infected individuals fully recover with treatment.
TB is Relatively Common
Although curable and preventable, TB is one of the world’s deadliest infectious diseases. According to the World Health Organization, an estimated 10.8 million people contracted TB in 2023, and 1.25 million people died from the disease that year. Fewer than 10,000 of the cases occurred in the US.
“I think the first misconception about TB is that it’s a rare and uncommon disease. We think of it as something that doesn’t really impact us anymore in 2025, but TB has been here, is here, and it’s something that’s relatively common,” said Michael Bernstein, MD, director of pulmonary and critical care at Stamford Health, Stamford, Conn., in the American Journal of Managed Care. “So, the fact that we would see a TB outbreak doesn’t surprise most pulmonologists.”
Clinical laboratories should monitor localized TB outbreaks as they are at the forefront for testing and detecting infectious diseases. Hospital labs may want to prepare for an upsurge in patients arriving with tuberculosis and other bacterial infections in the future.
Six-month trial program seeks to speed test turnaround times and increase patient safety
Hospitals around the world are increasingly employing drone services to deliver laboratory samples and medical supplies between clinical laboratories. One such six-month test program in the United Kingdom (UK) has drones quickly and efficiently transporting blood samples between Synnovis’ lab at Guy’s Hospital and the lab at St Thomas Hospital through the skies over London.
The medical centers are part of the Guy’s and St Thomas’ NHS Foundation Trust, which has five hospitals, including two of London’s most famous and prestigious teaching hospitals.
NHS partnered with healthcare logistics company Apian and Wing Drone Delivery, a global entity that’s part of Google’s parent company Alphabet, for the six-month drone-delivery trial.
The medical drone service currently delivers blood samples from patients who are at a high risk for complications from bleeding disorders.
Traditionally, delivering blood samples by road between the two locations takes about 30 minutes, depending on traffic. But delivery by drone between the two laboratories takes less than two minutes with the added benefit of decreasing carbon emissions and reducing traffic congestion.
And drone delivery allows for faster analysis of samples, which expedites test turnaround times and helps physicians more quickly determine if patients are safe to undergo surgery.
“This drone trial to deliver blood samples should speed up test results for some of our most vulnerable patients, ensuring they have the very best care,” said Lawrence Tallon, deputy chief executive of Guy’s and St Thomas’, in a news release. “It combines innovations in healthcare with sustainability to give us an NHS fit for the future.”
An NHS drone in flight over London passes by Big Ben. Total flight time is about two minutes, as opposed to 30 minutes by car or courier bike. Click on the photo above to watch a video of the drones in action. (Photo/video copyrights: NHS Guy’s and St Thomas’.)
On-demand Deliveries between Hospital Labs
“Cities like London face a unique challenge. Built vertically but relying on 2D roads, they’re choked by polluting congestion,” commented Alexander Trewby, CEO and co-founder of Apian, in the news release. “Apian’s ambition is to create an autonomous delivery network operating at NHS scale, moving physical items as productively as the internet moves information. If we can pioneer drone delivery here, we can do it anywhere!”
The project is regulated by the UK Civil Aviation Authority (CAA) and initially started in October of last year as a six-month trial, which ended on April 7. The CAA extended the project’s airspace approval for an additional six months. The NHS project now has an expected end date of October 7, 2025.
“Drones can increase the responsiveness and resilience of healthcare logistics, allowing clinicians to be more productive and patients to get the care they need sooner,” Hammad Jeilani, co-founder of Apian, told Healthcare-in-Europe.com. “An NHS drone delivery network in London, starting with this innovative trial, will provide on-demand, automated and sustainable deliveries, helping the NHS create more efficient models of working [with] our doctors and nurses to deliver the highest quality care for patients.”
The drone service runs Monday through Friday during daylight hours and cannot exceed 40 flights per day. During the first six months of operation, there were around 10 flights per day.
Informing Patient Care Quickly
“Tens of thousands of essential patient samples are analyzed by pathology laboratories across London each week,” said Dominic Harrington, PhD, chief scientific officer at Synnovis, in the NHS news release. “Reducing the time it takes to transport these samples means results are available more quickly to inform best possible patient care.”
The Wing drone used for the service is primarily made of foam, weighs about 11 pounds, and can carry packages weighing a little over two pounds. It cruises approximately 62 miles per hour at a height of around 230 feet above the ground.
The use of drones in healthcare is becoming more popular worldwide and the success of such endeavors is evident. In the future, clinical laboratories may depend on drone deliveries to help facilitate optimal results for patients.
Sophie O’Sullivan, director of future of flight at the CAA, told Healthcare-in-Europe.com, “Innovative trials like this from Guy’s and St Thomas’, Apian, and Wing help demonstrate the many positive and safe ways that drones can be used for society—in this case, to improve patient outcomes and deliver significant environmental benefits.”
The federal agency says it will mandate randomized, controlled clinical trials for vaccination of younger, healthy individuals
It’s been a confusing past few weeks in terms of what the general public’s access to COVID-19 vaccinations will be like in the future.
Public health experts have been verbally jousting with the federal Department of Health and Human Services (HHS) about moves its health officials made recently regarding the vaccines. This could put clinical laboratories on the front lines to help determine whether COVID cases—particularly severe ones—eventually rise as a result.
Food and Drug Administration (FDA) commissioner Martin A. Makary, MD, MPH, and Vinay Prasad, MD, MPH, who leads the agency’s vaccine oversight, announced on May 20 that the agency will require randomized, controlled clinical trials before approving COVID vaccines for healthy individuals under age 65.
“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” Makary and Prasad wrote in NEJM.
Under the new framework, they noted, the agency expects that it will continue to approve vaccines for adults over 65 as well as younger people with health conditions that put them at high risk of severe outcomes from COVID-19.
The range of diseases is “vast, including obesity and even mental health conditions such as depression,” they wrote. “Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner.”
In their NEJM commentary, FDA commissioner Martin Makary, MD (left), and Vinay Prasad, MD (right), wrote, “Moving forward, the FDA will adopt the following COVID-19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titers in people.” (Photo copyrights: Wikimedia Commons.)
Former CDC APIC Member Pushes Back
The announcement drew criticism from public health and medical experts.
“The FDA guidance presented in the NEJM was not released in the Federal Register, did not invite comment, and provided only a general outline for COVID-19 vaccine licensure,” wrote pediatrician and vaccinologist Kathryn M. Edwards, MD, in a commentary for STAT. Edwards is a former member of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), which makes vaccine recommendations to the agency.
On June 9, in an opinion piece for The Wall Street Journal, HHS Secretary Robert F. Kennedy Jr. announced that he’s removing all 17 current members of ACIP.
“The FDA mandate is to ensure safe and effective vaccines based on the clinical studies performed, but not to develop specific recommendations for their use,” Edwards added. “Providing recommendations on vaccine use for the civilian population is the mandate of the ACIP.”
Edwards contended that extensive data is already available on the safety and effectiveness of COVID-19 vaccines. She stated that “there is no precedent for mandating continued placebo-controlled randomized clinical trials for vaccines that have already been licensed.”
New Policy Announcement Raises Questions
The New York Times notes that many questions remain about the specifics of the new policy and how broadly the vaccines will be available.
A likely scenario, the paper reported, is that health insurers will play a role as “gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.” Without insurance coverage, people would likely pay approximately $140 per shot out of pocket.
This stands in contrast to European countries, where outreach campaigns target specific populations based on public health recommendations. according to Forbes. However, “in virtually all instances, COVID-19 vaccines can be gotten free of charge across Europe regardless of health or age status,” the article notes.
In their NEJM commentary, Prasad and Makary noted that adoption of the annual COVID-19 booster shot is already low. The CDC reported that 23% of Americans 18 and older received vaccinations in the 2024-2025 season, up slightly from 21.6% in 2023-2024.
Kennedy Steps In
On May 27, Kennedy announced in a video on X that the CDC would remove the COVID-19 vaccine from the recommended immunization schedule for healthy children and healthy pregnant women. Previously, the CDC recommended the vaccine for everyone ages six months and older.
Kennedy was joined in the video by Makary and National Institutes of Health director Jay Bhattacharya MD, PhD.
However, CDC staffers were “blindsided” by the announcement, NPR reported, citing an agency official who requested anonymity.
“Hours after the post on X, CDC staffers received a directive from Secretary Kennedy—dated May 19, but sent May 27—rescinding the department’s 2022 acceptance of the CDC’s recommendations for the use of COVID shots in children and during pregnancy,” NPR reported.
It now appears that HHS has at least partially backtracked on Kennedy’s announcement.
The CDC’s immunization schedule now states that vaccination of healthy children should be a matter of “shared clinical decision-making” between the doctor and parent or patient.
“After confusing, mixed messages from leaders at HHS earlier this week, we are relieved to see today that the CDC updated its schedules for child and adolescent immunizations to allow families to maintain the choice to immunize their children against COVID in consultation with their doctor,” American Academy of Pediatrics president Susan Kressly said in a statement from the organization.
In a June 1 interview with the CBS News program “Face the Nation,” Makary confirmed that the recommendation to vaccinate “should be with the patient and their doctor.”
However, he also criticized ACIP as a “kangaroo court where they just rubber stamp every single vaccine put in front of them.”
