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.
This follows class action lawsuits in multiple states against insurance companies that deny millions of healthcare claims each year
Artificial intelligence (AI) has become ubiquitous in many aspects of healthcare. But perhaps its most controversial use is in the payer denial-of-claims process. Multiple states are pursuing legislation that would limit or outright ban AI’s use without physician involvement.
Clinical laboratories experience payment denials at both the prior authorization stage when a doctor orders a lab test as well as when the claim is submitted for reimbursement. And many labs perform tests for which they know they will not be paid just to maintain the client account relationships with doctors.
Now, several states are taking measures to protect patients from what some say is a dangerous trend to use AI algorithms only to review and deny medical claims for critical healthcare and clinical laboratory testing. This will be of interest to lab managers and those in charge of their lab’s revenue.
“Physicians and patients already face daunting challenges in navigating medical insurers’ bureaucratic administrative processes,” said Arizona Medical Association (ArMA) President Nadeem Kazi, MD, in a news release. “Taking physicians’ clinical experience out of these processes entirely is a misguided step,” he added.
However, on March 13, the Arizona Senate’s Finance Committee altered the language in its version of the bill. In it, AI is not specifically mentioned.
Instead, the bill’s language now “requires a medical director or healthcare provider, before a healthcare insurer may deny a claim or issue a direct denial of a prior authorization, to individually review any denial that involves medical necessity or experimental status or that requires the use of medical judgment and prohibits the director or provider from relying solely on recommendations derived from any other source during the prior authorization denial or claim denial review.”
Presumably, “any other source” includes AI-driven software platforms used by payers for prior authorization denials and claims processing.
“While AI promises innovation for several areas of healthcare, the review and denial of medical insurance claims—some of which represent life-changing treatments and procedures—should be left to physicians who can make nuanced clinical judgments,” said Shelby Job, ArMA communications director, in a statement following that state’s passage of the House bill in February.
The bill is now being debated in the Arizona Senate. If the Senate passes its version, the two sides will need to reconcile their bills.
“Patients deserve healthcare delivered by humans with compassionate medical expertise, not pattern-based computer algorithms designed by insurance companies,” said ArMA President Nadeem Kazi, MD (above), in a news release. (Photo copyright: Arizona Medical Association.)
Multiple States Move to Limit Use of AI in Claims Denials
In an Arizona House of Representatives Committee on Commerce meeting, state Republican representative Julie Willoughby, who is also an ER nurse, said that “she hopes the bill will protect Arizonians from losing healthcare access due to AI interference,” NBC News reported following passage of the House bill.
“What we’re asking for in this is that any claims that are denied have a provider look them over for completeness to ensure that there isn’t anything that the AI algorithm may not have accounted for,” she said.
If signed into law, the bill will require a medical director at the insurance carrier in question to “individually review each claim or prior authorization before a healthcare insurer is able to deny a claim for that patient,” NBC News noted.
California passed similar legislation in September that would “ensure that a licensed physician supervises the use of AI decision-making tools when they are used to inform decisions to approve, modify, or deny requests by providers,” NBC News reported.
The author of the California bill, Democratic senator Josh Becker, JD, argued upon the bill’s passing that AI “should never replace the expertise and judgment of physicians,” adding, “An algorithm cannot fully understand a patient’s unique medical history or needs, and its misuse can lead to devastating consequences.”
And in Texas, a bill introduced by Republican senator Charles Schwertner, MD, states that AI “should not be used as the ‘sole basis of a decision to wholly or partly deny, delay, or modify healthcare services,’” NBC News reported.
In a statement, the Texas Coalition of Patients said the bill is “crucial in ensuring that life-altering healthcare decisions remain in the hands of medical professionals rather than Big Insurance’s automated systems.”
In all, 11 states have introduced legislation to “to push back on artificial intelligence use in reviewing medical claims,” according to NBC News.
In May 2023, The Dark Report explored payer claims denials, and it was acknowledged back then that automated systems were already reviewing claims.
And then there are the lawsuits. According to The Guardian, Cigna, Humana, and UnitedHealth all face class-action lawsuits concerning the use of AI to “deny lifesaving care.”
Can AI Coexist with Human-based Care?
Although at this time AI may not understand the nuanced complexities of healthcare claims, there seem to be plenty of uses for it in healthcare decision-making. It can analyze large sets of data for diagnosis, transcribe medical documents using automatic speech recognition, and streamline administrative tasks––all of which can help a workforce plagued by staff burnout and shortages, Los Angeles Pacific University noted.
And though its use in payer claims reviews and denials is being resisted, AI will likely continue to help doctors diagnose disease and make better treatment decisions. Nevertheless, clinical laboratory and pathology workers should be aware of how the tool is being used and keep an eye out for suspicious claims denials.
Patients outside the US wait even longer to see healthcare specialists with some appointments scheduled a year out in the Canadian province of Nova Scotia
Data recently released by healthcare consulting firm ECG Management Consultants (ECG) reveals that patients in the United States wait an average of 38 days for healthcare appointments. That figure is a significant stretch from the desired industry standard of 14-day or less wait times, according to Becker’s Hospital Review.
Clinical laboratories serve the needs of physicians who see patients and refer testing needed by patients to labs. Thus, average wait times should be of interest to lab professionals who strive to meet reporting turnaround times for lab test results, particularly given the unique way that ECG conducted its survey of patient wait times.
In “The Waiting Game: New-Patient Appointment Access for US Physicians,” ECG wrote, “Adopting a ‘secret shopper’ approach, we put ourselves in the shoes of the average patient trying to book an appointment. We contacted nearly 4,000 physician practices in 23 major cities across the US, posing as a new, commercially insured patient seeking care for general, nonemergent conditions that typically don’t require a physician referral.”
ECG’s study provides “a realistic view of where and in what specialties patients face the most significant challenges to accessing routine care,” the authors wrote in their published report. The report also includes patients’ appointment-keeping behavior based on length of wait times.
“Consumer expectations have evolved significantly in all industries. From buying a plane ticket to making a restaurant reservation, the consumer experience has been highly optimized and customers in turn have become accustomed to information and services being available at their fingertips. They bring the same expectations about speed and convenience to healthcare,” the researchers explained.
ECG pointed out that when patients are required to wait 14 days or more to see their physicians, no shows and cancellations increase dramatically.
“Numerous studies have shown that patients are significantly less likely to show up for appointments that are scheduled further out,” the study authors noted.
“One of the takeaways was how difficult the patient experience is. Not only did our secret shoppers have to go out and find physicians, they had to sit on the phone sometimes on very long holds and go through multiple barriers and jump through hoops,” Jennifer Moody (above), partner with ECG Management Consultants and one of the authors of the study, told Becker’s Hospital Review. “Even in that case, they weren’t successful in scheduling appointments with all the practices they called. I think of the average consumer who might be having a similar experience,” she added. Lengthy wait times are not believed to be an issue when patients need clinical laboratory tests. (Photo copyright: ECG Management Consultants.)
Getting Authentic Results
To gather the study data, ECG distributed its secret shoppers throughout 23 major US cities, reaching almost 4,000 physician practices (between 145-168 per city) to schedule appointments for non-emergency conditions not needing a physical referral.
The researchers gathered wait times for TNAAs (third next available appointments), a common metric. They chose TNAAs because first and second appointments often produce unclear results due to extenuating circumstances or late cancellations, Becker’s Hospital Review reported.
The researchers recorded TNAAs for the following specialties:
Cardiology (39 days),
Dermatology (40 days),
Family medicine (29 days),
Gastroenterology (48 days),
General surgery (22 days),
Neurology (63 days),
Obstetrics/gynecology (37 days),
Ophthalmology (37 days),
Orthopedic surgery (20 days),
Pediatrics (24 days), and,
Rheumatology (68 days).
They found the average wait time to be 38 days. And “of the 253 metropolitan market and specialty combinations included in this research, only 6% had an average wait time of 14 days or less,” Becker’s reported.
The researchers omitted the physician practices that were unable to either take or return calls, take messages, or provide a hold time under five minutes to give the secret shopper an answer, Becker’s added.
Jennifer Moody, Partner, ECG Management Consultants, one of the authors of the study, “was particularly surprised by the portion of callers who never even made it to the stage of learning about wait times. Out of 3,712 physician practices, callers were able to secure responses from only 3,079, meaning nearly one in five physician practices could not provide appointment availability information,” Becker’s reported.
The lowest average wait time in all specialties was 27 days in Houston, and the longest was 70 days in Boston. “A key takeaway from the report is that physician concentration does not guarantee timely access, as a major healthcare hub like Boston helps illustrate,” Becker’s noted, adding that physicians in such areas may “devote time to teaching or research over appointments.”
The graphic above, taken from ECG’s published report, shows the average TNAA times recorded by their secret shoppers at medical specialty practices in major cities across the US. (Graphic copyright: ECG Management Consultants.)
Other Country’s Wait Times
Healthcare systems outside the US struggle with patient wait times as well. Forbes reported that patients of Canada’s public health system “faced a median wait of 27.7 weeks for medically necessary treatment from a specialist after being referred by a general practitioner. That’s over six months—the longest ever recorded.”
Patients in Nova Scotia wait even longer. There they “face a median wait of 56.7 weeks—more than a year—for specialist treatment following referral by a general practitioner. Those on Prince Edward Island are also in the year-long waiting club—a median of just over 55 weeks,” Forbes noted.
And in the UK, a recent survey found that “more than 150,000 patients had to wait a day in A&E [accident and emergency] before getting a hospital bed last year, according to new data,” with the majority of those patients over the age of 65, according to The Guardian.
ECG suggestions that may reduce wait times include:
Adopt automation and self-service tools in an “easily navigable platform” that enables patients to schedule appointments 24/7.
Ensure healthcare providers are “utilized appropriately and at the top of their license.”
Address inequities in access to healthcare regardless of patients’ location or socioeconomic status.
There is more in the ECG report that hospitals—as well as clinical laboratories—can use to reduce patient wait times to see care providers. As the authors wrote, “For patients, the first step of the care journey shouldn’t be the hardest.”
Regulatory agencies in UK and US have yet to address dangers inherent in customer misunderstanding of DTC medical laboratory genetic test results
Direct-to-consumer (DTC) medical laboratory genetic tests are gaining popularity across the globe. But recent research out of the United Kingdom questions the reliability of these tests. The study, according to The Guardian, found that “Over the counter genetic tests in the UK that assess the risk of cancer or heart problems fail to identify 89% of those in danger of getting killer diseases.”
According the PGS website, “each PGS in the catalog is consistently annotated with relevant metadata; including scoring files (variants, effect alleles/weights), annotations of how the PGS was developed and applied, and evaluations of their predictive performance.”
However, the researchers told The Guardian, “Polygenic risk scores performed poorly in population screening, individual risk prediction, and population risk stratification. Strong claims about the effect of polygenic risk scores on healthcare seem to be disproportionate to their performance.”
“Strong claims have been made about the potential of polygenic risk scores in medicine, but our study shows that this is not justified,” Aroon Hingorani, PhD (above), Professor of Genetic Epidemiology at UCL and lead author of the study, told The Guardian. “We found that, when held to the same standards as employed for other tests in medicine, polygenic risk scores performed poorly for prediction and screening across a range of common diseases.” Consumer misunderstanding of DTC medical laboratory genetic tests is a real danger. (Photo copyright: University College London.)
Polygenic Scores Not Beneficial to Cancer Screening
To complete their study, the UCL researchers compared PGS genetic risk data to conventional clinical laboratory testing methods and discovered some troubling results. They include:
On average, only 11% of individuals who developed a disease had been identified by the tests.
A 5% false positive rate where people were informed that they would get a disease within 10 years but did not.
PGS only identified 10% of people who later developed breast cancer.
The researchers state in their BMJ Medicine paper that polygenic risk scores are not the same as testing for certain gene mutations, which could be critical in screening for some cancers. They also wrote that discovering genetic variants associated with the risk for disease is still crucial for drug development.
“It has been suggested that polygenic risk scores could be introduced early on to help prevent breast cancer and heart disease but, in the examples we looked at, we found that the scores contributed little, if any, health benefit while adding cost and complexity,” research physician and epidemiologist Sir Nicholas Wald, FRS, FRCP, FMedSci, Professor of Preventive Medicine at UCL Institute of Health Informatics and co-author of the study, told the Jersey Evening Post.
“Our results build on evidence that indicates that polygenic risk scores do not have a role in public health screening programs,” Wald added.
“This research study rightly highlights that for many health conditions genetic risk scores alone may have limited usefulness, because other factors such as deprivation, lifestyles, and environment are also important,” clinical epidemiologist Raghib Ali, MD, CEO, Chief Investigator and Chief Medical Officer, Our Future Health UK, told The Guardian.
Our Future Health is a collaboration between public, non-profit, and private sectors to create the UK’s largest health research program. The researchers in this endeavor intend to recruit over five million volunteers and use polygenic risk scores to develop innovative ways to prevent, detect, and treat disease. This program is funded by the UK’s National Health System (NHS).
“[Our] research program will be developing integrated risk scores that will take in all the important risk factors,” Ali explained. “We hope these integrated risk scores can identify people more likely to develop diseases, but this is a relatively new area of science and there are still unanswered questions around it.”
Danger of Misunderstanding DTC Genetic Tests
Here in the US, there have been news stories in recent years about the unreliability of certain genetic tests. Dark Daily covered these stories in previous ebriefs. News stories about the unreliability of genetic tests, particularly those marketed directly to consumers, reveal the problems that existing regulatory schemes have yet to address.
In “Consumer Reports Identifies ‘Potential Pitfalls’ of Direct-to-Consumer Genetic Tests,” we covered CR’s findings that though clinical laboratory and pathology professionals understand the difference between a doctor-ordered genetic health risk (GHR) test and a direct-to-consumer (DTC) genetic test, the typical genetic test customer may not. And that, misunderstanding the results of a DTC at-home genetic test can lead to confusion, loss of privacy, and potential harm.
Scientific American also covered the dangers of DTC testing in “The Problem with Direct-to-Consumer Genetic Tests,” in which the author notes that “despite caveats in ads and on packages, users can fail to understand their limitations,” and that “consumer-grade products are easily misconstrued as appropriate medical tests and create false reassurances in patients who could be at legitimate risk.”
Most clinical laboratory managers and pathologists are probably not surprised that the research performed at UCL shows that there are still issues surrounding genetic tests, particularly those marketed directly to consumers. While direct-to-consumer DNA tests can have some benefits, at this time, they are not always the best option for individuals seeking information about their personal risk for hereditary diseases.
Already-existing clinical laboratory blood test may be new standard for detecting Alzheimer’s biomarkers
In Sweden, an independent study of an existing blood test for Alzheimer’s disease—called ALZpath—determined that this diagnostic assay appears to be “just as good as, if not surpass, lumbar punctures and expensive brain scans at detecting signs of Alzheimer’s in the brain,” according to a report published by The Guardian.
Alzheimer’s disease is one of the worst forms of dementia and it affects more than six million people annually according to the Alzheimer’s Association. Clinical laboratory testing to diagnose the illness traditionally involves painful, invasive spinal taps and brain scans. For that reason, researchers from the University of Gothenburg in Sweden wanted to evaluate the performance of the ALZpath test when compared to these other diagnostic procedures.
Motivated to seek a less costly, less painful, Alzheimer’s biomarker for clinical laboratory testing, neuroscientist Nicholas Ashton, PhD, Assistant Professor of Neurochemistry at the University of Gothenburg, led a team of scientists that looked at other common biomarkers used to identify changes in the brain of Alzheimer’s patients. That led them to tau protein-based blood tests and specifically to the ALZpath blood test for Alzheimer’s disease developed by ALZpath, Inc., of Carlsbad, Calif.
In their JAMA article, they wrote, “the pTau217 immunoassay showed similar accuracies to cerebrospinal fluid biomarkers in identifying abnormal amyloid β (Aβ) and tau pathologies.”
In an earlier article published in medRxiv, Ashton et al wrote, “Phosphorylated tau (pTau) is a specific blood biomarker for Alzheimer’s disease (AD) pathology, with pTau217 considered to have the most utility. However, availability of pTau217 tests for research and clinical use has been limited.”
Thus, the discovery of an existing pTau217 assay (ALZpath) that is accessible and affordable is a boon to Alzheimer’s patients and to the doctors who treat them.
“The ALZpath pTau217 assay showed high diagnostic accuracy in identifying elevated amyloid (AUC, 0.92-0.96; 95%CI 0.89-0.99) and tau (AUC, 0.93-0.97; 95%CI 0.84-0.99) in the brain across all cohorts. These accuracies were significantly higher than other plasma biomarker combinations and equivalent to CSF [cerebrospinal fluid] biomarkers,” an ALZpath press release noted.
“This is an instrumental finding in blood-based biomarkers for Alzheimer’s, paving the way for the clinical use of the ALZpath pTau217 assay,” stated Henrik Zetterberg, MD, PhD (above), Professor of Neurochemistry at the University of Gothenburg and co-author of the study. “This robust assay is already used in multiple labs around the globe.” Clinical laboratories may soon be receiving doctors’ orders for pTau217 blood tests for Alzheimer’s patients. (Photo copyright: University of Gothenburg.)
Study Details
Ashton’s team conducted a cohort study that “examined data from three single-center observational cohorts.” The cohorts included:
“Participants included individuals with and without cognitive impairment grouped by amyloid and tau (AT) status using PET or CSF biomarkers. Data were analyzed from February to June 2023,” the researchers wrote.
These trials from the US, Canada, and Spain featured 786 participants and featured “either a lumbar puncture or an amyloid PET scan to identify signs of amyloid and tau proteins—hallmarks of Alzheimer’s disease,” The Guardian reported, adding that results of the University of Gothenburg’s study showed that the ALZpath pTau217 blood test “was superior to brain atrophy assessments, in identifying signs of Alzheimer’s.”
“80% of individuals could be definitively diagnosed on a blood test without any other investigation,” Ashton told The Guardian.
Diagnosis Needed to Receive Alzheimer’s Disease Treatments
“If you’re going to receive [the new drugs], you need to prove that you have amyloid in the brain,” Ashton told The Guardian. “It’s just impossible to do spinal taps and brain scans on everyone that would need it worldwide. So, this is where the blood test [has] a huge potential.”
Even countries where such drugs were not yet available (like the UK) would benefit, Ashton said, because the test, “Could potentially say that this is not Alzheimer’s disease and it could be another type of dementia, which would help to direct the patient’s management and treatment routine.”
However, Ashton himself noted the limitations of the new findings—specifically that there is no success shown yet in Alzheimer’s drugs being taken by symptom-free individuals.
“If you do have amyloid in the brain at 50 years of age, the blood test will be positive,” he said. “But what we recommend, and what the guidelines recommend with these blood tests, is that these are to help clinicians—so someone must have had some objective concern that they have Alzheimer’s disease, or [that] their memory is declining,” he told The Guardian.
Experts on the Study Findings
“Blood tests could be used to screen everyone over 50-years old every few years, in much the same way as they are now screened for high cholesterol,” David Curtis, MD, PhD, Honorary Professor in the Genetics, Evolution and Environment department at University College London, told The Guardian.
“Results from these tests could be clear enough to not require further follow-up investigations for some people living with Alzheimer’s disease, which could speed up the diagnosis pathway significantly in future,” Richard Oakley, PhD, Associate Director of Research and Innovation at the Alzheimer’s Society, UK, told The Guardian.
Though Oakley found the findings promising, he pointed out what should come next. “We still need to see more research across different communities to understand how effective these blood tests are across everyone who lives with Alzheimer’s disease,” he said.
“Expanding access to this highly accurate Alzheimer’s disease biomarker is crucial for wider evaluation and implementation of AD blood tests,” the researchers wrote in JAMA Neurology.
“ALZpath makers are in discussions with labs in the UK to launch it for clinical use this year, and one of the co-authors, Henrik Zetterberg, MD, PhD, Professor of Neurochemistry at the University of Gothenburg, is making the assay available for research use as part of the ‘biomarker factory’ at UCL,” The Guardian reported.
In the US, to be prescribed any of the available Alzheimer’s medications, a doctor must diagnose that the patient has amyloid in the brain. A pTau217 diagnostic blood test could be used to make such a diagnosis. Currently, however, the test is only available “for research studies through select partner labs,” Time reported.
“But later this month, doctors in the US will be able to order the test for use with patients. (Some laboratory-developed tests performed by certain certified labs don’t require clearance from the US Food and Drug Administration.),” Time added.
It may be that the University of Gothenburg study will encourage Alzheimer’s doctors in the UK and around the world to consider ordering pTau217 diagnostic blood tests from clinical laboratories, rather than prescribing spinal taps and brains scans for their Alzheimer’s patients.
