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.
NPR reports that the shamed Theranos founder/CEO is providing advice to Evans, but the startup denies that claim
Prison bars can’t block Elizabeth Holmes from finding her way back into the news spotlight. The disgraced founder and former CEO of Theranos is reportedly advising her partner Billy Evans on his new artificial intelligence (AI) diagnostic startup company, named Haemanthus after the blood lily.
According to sources who spoke with NPR, Evans’ new company Haemanthus, Inc. is developing a blood testing device and has patented a process that uses Raman spectroscopy, which, according to NPR, “has been shown to help diagnose ALS, also called Lou Gehrig’s disease, as well as some forms of cancer. It has also been used to discover improvised explosive devices on battlefields.”
Evans has already raised millions of dollars for the fledgling startup, NPR reported, adding that a source claimed finances for the company have come from “mostly friends, family, and other supporters so far.”
According to Newsweek, Evans’ goal is to raise $50 million toward the development of a “medical testing product.”
The company will “do medical tests using bodily fluids,” Newsweek reported, adding, “An image of the alleged device published by The New York Times is eerily similar to Theranos’ ‘Edison’ testing machine.”
Elizabeth Holmes is currently housed in a federal facility in Bryan, Texas. Sources told NPR that she has been “providing advice” to Billy Evans, her partner, on his new AI/medical testing company Haemanthus, which denied those claims stating on X that Holmes “has no role, now or future.” (Photo copyright: Wikimedia Commons.)
Haemanthus Denies Holmes’ Involvement
Holmes has reportedly been providing insight to Evans throughout her prison term, though her role with his budding company is unclear, NPR noted.
As previously reported by Dark Daily, Holmes is “barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the healthcare sector.”
Haemanthus denied Holmes’ involvement with the company, claiming that she “has no formal role” and that “Haemanthus is not Theranos 2.0,” Fortune reported.
Previous lengthy posts by Haemanthus on social media platform X fully denied any involvement with Holmes but have since been deleted. The company now uses their platform to curtly retort the significance of Holmes’ involvement, leaning on their advancements and high standards. “Skepticism is rational. We must clear a higher bar,” they said. “When The NY Times contacted us, we invited them to see our lab, tech, and team. They declined. The headline was already written. Our reality inconvenient.”
Further posts on X showcase Haemanthus’ desire to have the same groundbreaking prowess Holmes clung to throughout her Theranos venture. The company claims to have developed “the world’s first AI-native sensors for health,” adding, “Our technology captures thousands of biomarkers simultaneously.”
And the Holmes Saga Continues
Haemanthus is comprised of about a dozen people, including individuals who “worked with Evans at Luminar Technologies, which develops sensor technology for autonomous vehicles, according to the company’s patent and Delaware incorporation paperwork,” NPR reported.
Holmes is currently serving an 11-year federal prison sentence for her role in fraud involving Silicon Valley startup Theranos, which boasted clinical laboratory blood-test breakthroughs that turned out to be riddled with faulty equipment and fraudulent results.
Though whistleblowers brought Holmes scheme to the light, she has never admitted wrongdoing for her actions and continues to claim her innocence. In May, the Ninth Circuit of Appeals denied her request for a rehearing of her case.
New EHR installations may require new laboratory information system upgrades and interfaces
Electronic health record (EHR) systems continue to be one of the costliest investments healthcare providers can make. And the company that holds the largest portion of the EHR market is Epic, with anywhere from 36% to 44%, according to various published reports and research briefs.
Healthcare executives remorseful about the cost of their hospital’s EHR may take solace in Becker’s Health IT’s recent list of the “most expensive” Epic EHR installations. It is common for the largest projects to cross the $1 billion mark.
Clinical laboratory leaders tasked with interfacing their hospital’s laboratory information system (LIS) with their healthcare system’s EHR may find the following information useful. The investment in time begins months before the actual EHR implementation.
One example is Lake Charles Memorial Health System (LCMHS) Lake Charles, La. In a blog post, the health system reported that it took 18 months for its physicians, clinicians, and staff to prepare for the installation of their new Epic MyChart EHR.
“There are lots of things we wish our customers would do to make sure their system runs well. Making sure every user is trained, for example. Putting in upgrades quickly. Making sure that the hardware runs fast enough,” wrote Judy Faulkner, Epic founder and CEO, in an Epic blog post.
“The LCMHS staff and physicians have championed this project from the beginning, and I have them to thank for the success of this EMR transition and look forward to seeing the positive impacts as we settle into the operational changes and new experiences Epic brings Lake Charles Memorial Health System and those we serve,” said Devon Hyde (above), President and CEO of Lake Charles Memorial Health System, about the provider’s transition to a new Epic MyChart EHR. (Photo copyright: Lake Charles Memorial Health System.)
Top 10 Most Expensive Epic EHR Installs of 2024
While Becker’s noted that the following compilation is “not an exhaustive list,” here’s its list of the top 10 most expensive Epic EHR projects based on publicly available sources.
KLAS reported that among the healthcare leaders KLAS interviewed:
27% had “an above-average EHR post-implementation” likely due to “providing technological foundation needed” at go-live, while,
40% said implementation of the EHR “had significant misses” and,
22% reported “average satisfaction with room for improvement.”
Providing staff with adequate training may smooth the way for new EHRs, according to the KLAS report. “Often, leaders wish they had invested in more training time and workflow-specific training in the context of patient care,” the authors wrote.
New EHR May Mean New LIS
Pathologists and clinical laboratory leaders may need to transition the laboratory information system (LIS) when the healthcare organization moves to a new EHR. At the very least, new interfaces will be required.
While a new EHR and LIS requires significant investments, they also provide opportunities for needed upgrades, competitive advantage, and security.
Pathologists and clinical laboratories will play a key role in collecting the data needed to create a person’s digital twin
Digital twins is a promising new technology that is making a big impact in healthcare. This development is significant because clinical laboratory test results will be among the most important sets of data to go into the creation of a patient’s “digital twin.”
A digital twin is defined by IBM as “a virtual representation of an object or system designed to reflect a physical object accurately. It spans the object’s lifecycle, is updated from real-time data, and uses simulation, machine learning, and reasoning to help make decisions.”
“We define a digital twin for healthcare as a virtual representation of a person which allows dynamic simulation of potential treatment strategy, monitoring and prediction of health trajectory, and early intervention and prevention, based on multi-scale modeling of multi-modal data such as clinical, genetic, molecular, environmental, and social factors, etc.,” wrote the authors of a review article published in NPJ Digital Medicine titled, “Digital Twins for Health: A Scoping Review.”
“The concept of digital twin for health (DT4H) holds great promise to revolutionize the entire healthcare system, including management and delivery, disease treatment and prevention, and health well-being maintenance, ultimately improving human life,” wrote study lead Eva Katsoulakis, MD (above), clinical informaticist and radiation oncologist at Tampa General Hospital in Florida, et al, in a review article she and her team published in NPJ Digital Medicine. Clinical laboratory test data will be a key element in the creation of a patient’s digital twin. (Photo copyright: Tampa General Hospital.)
Development of Digital Twins
Something akin to digital twins was first used in 1960 at NASA when replicas of spacecrafts currently on a mission in space were duplicated and studied on Earth. In 1991, Michael Grieves introduced the concept to manufacturing while at University of Michigan’s College of Engineering. The technology was later coined “digital twins” by John Vickers, a principal technologist in advanced manufacturing at NASA in 2010, IBM noted.
The increased use of digital twins in healthcare has brought some brilliant advancements. Examples, as reported by Computer Weekly, include:
Surgery and treatment: Boston Children’s Hospital uses digital twins to examine the complexities of heart procedures in reference to oxygen, blood flow, and valve pressure. Real-time analysis helps with surgeries and treatments, allowing clear visualization at all angles.
Metabolic analysis to tackle kidney failures: Digital twins are being used in Singapore to “Replicate metabolic fluxes to predict chronic kidney disease in type 2 diabetes mellitus.” Doctors there hope to curb the spike of chronic kidney disease found in type 2 diabetes mellitus. Their country has seen cases double in the last 40 years.
Bacterial predictions, E. coli: Bacteria behavior is being analyzed in computational simulations as part of a Simulating Microbial Systems (SMS) program. Run by the US Defense Advanced Research Projects Agency, the “SMS seeks interdisciplinary, comprehensive, and integrated workflows to generate unknown parameters from new data to inform computational models that can predict E. coli.”
Full body data: Precisely personalized care is the goal of European Virtual Human Twins Initiative, a project from the European Commission. The group creates digital twins and updates them with an individual’s personal conditions and health information that shifts as they age, keeping prevention as a focal point.
Respiratory viral pathogens: The complexities and variety of causes behind respiratory infections makes it an ideal area for digital twins. Its use in hospital ICUs can help doctors consider pneumonia treatment outlooks and develop plans for spread of infection.
Pharmaceuticals: Many pharma companies are opting to use digital twins since drug development is highly expensive and animal testing does not always provide clear data compared to human testing. Examples include Orion Pharma, which paired with AstraZeneca and Bayer to create digital twins that “capture genetic and molecular interactions that causally drive clinical and physiological outcomes.” Immunology company, Sanofi, also is using digital twins as “an essential first step to improve efficacy and safety.”
Future of Digital Twins in Healthcare
While digital twin development within healthcare is still in early stages, it promises to pioneer much change.
“When you have this model, you can personalize with certain features, certain anatomy, then you can try things. In heart surgery, you can’t try 20 different things, you only have one shot,” Ellen Kuhl PhD, professor of engineering and bioengineering at Stanford University, told Computer Weekly.
As technology advances and personalized healthcare continues to trend, it is likely digital twins will have a long-term place in medical practices. Astute clinical laboratory professionals will watch the expansion of this trend, since lab data will play such a key role in its development.
Holmes says life in prison is ‘Hell’ and that Theranos was a failure but ‘not fraud’
For some reason disgraced Theranos founder and ex-CEO Elizabeth Holmes, in a lengthy interview with People magazine, described life in prison while raising her two children even as a three-judge panel of the US 9th Circuit Court of Appeals affirmed her conviction and 11.25-year sentence for fraud.
In June of 2024, Holmes’ defense team appealed to have her conviction overturned due to alleged errors in her trial. According to court documents containing the federal judges’ decisions, her attorneys argued that:
Former Theranos employees who testified as lay witnesses should not have been allowed to offer improper expert testimony.
The court abused its discretion by allowing testimony that Theranos voided all patient sample tests run on a device used in Theranos’s clinical laboratory.
Her rights were violated under the Confrontation Clause of the Sixth Amendment when she was prohibited from cross-examining a former Theranos laboratory director on aspects of his post-Theranos employment.
In February 2025, the judges rejected all points and denied her appeal. Holmes is serving her sentence in a minimum security federal prison camp in Texas and is currently scheduled to be released in 2032.
Elizabeth Holmes (above) taken backstage at TechCrunch Disrupt San Francisco 2014 when Holmes was at the height of her fame and popularity. At this point, Theranos’ Edison blood testing device had not yet been shown to be a fake. But as clinical laboratory scientists and anatomic pathologists studied the technology it was shown to be incapable of producing the results claimed by Holmes and her company president Ramesh Balwani. Today, both are serving lengthy prison sentences for defrauding investors. (Photo copyright: Max Morse/Wikimedia Commons.)
‘Nothing More than a Mirage’
Holmes was convicted in 2022 and sentenced to 135 months for her role in the Theranos fraud case. She was also ordered to pay approximately $452 million in restitution due to her offense, which resulted in significant financial losses to various entities and individuals.
Holmes’ one-time romantic partner and former president of Theranos Ramesh “Sunny” Balwani also was convicted of several fraud charges and sentenced to 155 months in prison.
Theranos claimed to have invented a device called Edison that could run a variety of fast, accurate, and affordable clinical laboratory diagnostic tests from a single finger prick of blood. That’s in contrast to traditional testing methods that require veinous blood drawn with a hypodermic needle. The reality, however, was that the Edison device did not work as described to investors.
“The vision sold by Holmes and Balwani was nothing more than mirage,” wrote 9th Circuit Judge Jacqueline Nguyen, JD, in the panel’s decision, adding that the “grandiose achievements touted by Holmes and Balwani were half-truths and outright lies.”
The judges continued: “Theranos’s blood-testing device failed to deliver faster and more accurate testing results than conventional technology. Pharmaceutical companies never validated the technology, as Holmes and Balwani had told investors. Contrary to the rosy revenue projections shared with investors and business partners, Theranos was running out of money.”
Life Behind Bars
Holmes told People she has adjusted to prison life, waking up every morning just after 5 AM. Her routine includes daily exercise and working as a reentry clerk. Holmes, who was once touted as having an estimated worth of $4.5 billion, now earns just 31 cents an hour teaching fellow inmates how to prepare resumes and apply for jobs and government benefits.
“So many of these women don’t have anyone, and once they’re in there, they’re forgotten,” she told People.
Holmes also teaches French and participates in cognitive and behavioral therapy for post-traumatic stress disorder (PTSD) to address past traumas, including the downfall of Theranos, which was once valued at $9 billion.
“It’s surreal,” she said. “People who have never met me believe so strongly about me. They don’t understand who I am. It forces you to spend a lot of time questioning belief and hoping the truth will prevail. I am walking by faith and, ultimately, the truth. But it’s been hell and torture to be here.”
Raising Children from Prison
Holmes’ trial was delayed three times due to the COVID-19 pandemic and then a fourth time due to a pregnancy. She gave birth to son William a few weeks before her trial began. She later gave birth to daughter Invicta. Both children are being raised by their father Billy Evans, Holmes’ current partner.
Critics allege Holmes only had children to gain sympathy and attempt to avoid prison time. In the People interview, she tried to dispel those claims.
“I know how the optics look, but I always wanted to be a mother,” she said. “I wanted to have children, be a mom. I truly did not think I would ever be convicted or found guilty. I kept talking to my lawyers and they also assured me we would never get this far.
“It wasn’t planned, and I can’t worry about what others think,” she added. “It’s just when the timing happened.”
Holmes’ children will be nine and 10 years-old when she’s slated for release in 2032. She continues to maintain her innocence and considers her trial and conviction a miscarriage of justice. She asserts that while Theranos was a flop, “failure is not fraud.”
“First it was about accepting it happened. Then it was about forgiving myself for my own part. [And] I refused to plead guilty to crimes I did not commit,” Holmes said.
Interestingly, Holmes intends to return to the healthcare industry upon her release. “There is not a day I have not continued to work on my research and inventions,” she told People. “I remain completely committed to my dream of making affordable healthcare solutions available to everyone.”
How she plans to do that given the federal government has banned her for life from operating a clinical laboratory and participating in federal health programs is anyone’s guess.
And thus the life and times saga of Elizabeth Holmes continues.
Innovative in-office test, when integrated with UTI microbiology testing performed by clinical laboratories, could contribute to better patient outcomes
Treatments for certain bacterial infections are becoming less effective due to antimicrobial resistance (AMR). Now, after a 10-year-long worldwide competition, the first multi-million euro prize for an accurate, rapid, and cost effective clinical laboratory test for diagnosing and treating urinary tract infections (UTIs) went to Sysmex Corporation’s subsidiary Astrego. This milestone event could benefit tens of millions of people who suffer from UTIs annually.
Astrego, of Uppsala, Sweden, won the €8 million (US$8.19 million) Longitude Prize on AMR for its PA-100 AST System. The new diagnostic technology will “transform treatment of urinary tract infections and brings the power of clinical laboratory testing into a doctor’s office,” according to a news release from Challenges Works, the United Kingdom-based organization that organized and awarded the prize.
The Astrego system is, according to Challenge Works’ website, a “game-changing solution” in “a novel point-of-care diagnostic test that rapidly and accurately identifies the presence of a bacterial infection and the right antibiotic to prescribe.”
“We launched the Longitude Prize on AMR (in 2014) to create the urgent ‘pull’ needed to get innovators working on one of the biggest life-and-death challenges facing humanity. Hundreds of teams [that] competed with multiple solutions [are] now close to market thanks to the prize,” said Tris Dyson, Managing Director, Challenge Works, in a news release.
The new diagnostic technology “could herald a ‘sea change’ in antibiotic use” according to the judges of the competition, The Guardian reported.
“The PA-100 AST System (above) creates a future where patients can quickly and accurately get a diagnosis and the correct treatment when they visit the doctor,” said Sherry Taylor, MD, UK National Health Service, Temple Fortune Medical Group, London, in the Challenge Works news release. “Accurate, rapid diagnosis of bacterial infections that help doctors and health workers to manage and target antibiotics, will slow the development and spread of antibiotic resistant infections, improve healthcare and save potentially millions of lives,” she added. In-office point-of-care systems like the PA-100 may reduce the number of doctor orders for UTI tests to clinical laboratories while contributing to better patient outcomes. (Photo copyright: Sysmex.)
How the Test Works
In the UK, people are treated for UTIs more than any other infection. It takes about three days for doctors to receive the results from traditional microbiology testing. They then prescribe an antibiotic to treat the infection. But about half of “infection-causing bacteria are resistant to at least one antibiotic,” according to a news release from the Geneva, Switzerland-based NESTA Foundation which funded the Longitude Prize on AMR.
“It’s impossible to overstate how critical it is to address AMR [antimicrobial resistance]. By 2050, it is predicted to cause 10 million deaths a year—matching those caused by cancer—and cost $1 trillion in additional health costs,” the news release states.
UTI are more common in women and the reason for eight million healthcare appointments annually in the US, according to Medscape.
The PA-100 AST system makes it possible for patients to provide a small urine sample during their appointments with doctors, find out if they have a bacterial infection in 15 minutes, and receive the “right antibiotic to treat it within 45 minutes,” NESTA said. Sysmex describes the PA-100 AST as an “automated phenotypic analyzer, based on EUCAST standards,” that combines “phase-contrast microscopy and nanofluidics to make available antibiograms at point of care.” It enables healthcare providers to perform antimicrobial susceptibility testing (AST) in-office rather than sending out urine samples to microbiology laboratories.
The systems works as follows, according to the Sysmex website:
As a urine sample passes through the chip, “single bacterial cells are trapped in individual channels.”
Meanwhile, “larger cellular components” are filtered and kept out of the nanofluidic chip.
Contrast-phase microscopy enables real-time monitoring of cell growth. “Resistant bacteria keep a higher growth rate during incubation, while susceptible ones grow slowly or lyse.”
Expert computer software identifies that bacterial strain, delivers an “easy to interpret antibiogram after assay completion” and provides an “informed prescription decision” on which antibiotic is expected to fight the infection.
“The PA-100 AST System challenges bacteria present in a patient’s urine with microscopic quantities of antibiotics in tiny channels embedded in a cartridge the size of a smartphone,” said Mikael Olsson, CEO and co-founder of Sysmex Astrego, in The Microbiologist.
“We rapidly pinpoint whether a bacterial infection is present and identify which antibiotic will actually kill the bugs, guiding doctors only to prescribe antibiotics that will be effective,” he added.
Sysmex is conducting more studies in the UK and working with regulators in Europe for clearances, according to Olsson.
Older Antibiotics May Make Comeback
It’s possible that use of the PA-100 system to identify the best antibiotic to treat infections could lead to a resurgence in the use of previously retired antibiotics.
“Roughly 25-30% of patients have infections resistant to older first-line antibiotics which have been retired as a result; this means the remaining 70-75% of patients could still benefit from those older drugs,” Pathology in Practice reported, adding, “Since the PA-100 AST System identifies which specific antibiotic can treat an infection, it will likely allow retired antibiotics to be brought back into service because the test is able to demonstrate when an infection is susceptible to their effects.”
Many people could benefit from the older antibiotics, Challenge Works noted.
Revolutionizing Healthcare
The Sysmex Astrego’s PA-100 AST System is a significant development.
“Currently, I send the urine sample off for analysis, and it usually takes around three days to come back with results,” said Sherry Taylor, MD, UK National Health Service, Temple Fortune Medical Group, London, in the Challenge Works news release. “Having a bedside test that would enable rapid diagnosis through antibiotic susceptibility testing would revolutionize general practice and patient care. It’s all about using antibiotics only when necessary and appropriate.”
Each individual test costs about €25 (US$25.72), The Guardian reported, adding that ramped up production may lower the price.
The PA-100 AST System is the latest example of a diagnostic/therapeutic solution developed in Europe rather than the US, which is often slower to award regulatory clearance.
It also is another test that will be performed outside of traditional clinical laboratory settings, demonstrating the trend to move medical laboratory tests closer to patients.
