New AI tool doubled efficiency in busy university radiology department
Creative artificial intelligence (AI) solutions are being developed to address critical staffing shortages in radiology that could help with similar shortages in overworked pathology and clinical laboratories as well.
In a recent clinical study at 11-hospital Northwestern Medicine, researchers developed a new generative AI radiology tool to assist radiologists that demonstrates high accuracy and efficiency rates when working with multiple types of imaging scans.
For the study, approximately 24,000 radiology reports were analyzed and then compared for clinical accuracy with and without the AI tool. The tool evaluates an entire scan and generates a report that is 95% complete and personalized to each patient. A template based on that report is then provided to radiologists for review, according to a Northwestern Medicine Feinberg School of Medicine news release.
The study reported an average 15.5% increase in radiograph efficiency without compromising accuracy. Some radiologists even produced gains as high as 40%. The radiology reports were scrutinized during a five-month period last year and enabled radiologists to improve the time it took to return a diagnosis.
“This is, to my knowledge, the first use of AI that demonstrably improves productivity, especially in healthcare. Even in other fields, I haven’t seen anything close to a 40% boost,” said the study’s senior author Mozziyar Etemadi, MD, PhD, assistant professor of anesthesiology and biomedical engineering at Northwestern University McCormick School of Engineering, in the news release. (Photo copyright: Northwestern University.)
Doubled Efficiency for One Radiology Team
“For me and my colleagues, it’s not an exaggeration to say that it doubled our efficiency. It’s such a tremendous advantage and force multiplier,” said study co-author Samir Abboud, MD, emergency radiology in the department of radiology at Northwestern Medicine, in the news release.
“Having a draft report available, even before it is viewed by the radiologist, offers a simple, actionable datapoint that can be quickly and efficiently acted upon” added study senior author Mozziyar Etemadi, MD, PhD, assistant professor of anesthesiology and biomedical engineering at Northwestern University McCormick School of Engineering, in the news release. “This is completely different than traditional triage systems, which need to meticulously be trained one by one on each and every diagnosis.”
The AI tool can also alert radiologists to life-threatening conditions.
“On any given day in the ER, we might have 100 images to review, and we don’t know which one holds a diagnosis that could save a life,” Abboud said. “This technology helps us triage faster—so we catch the most urgent cases sooner and get patients to treatment quicker.”
Relying on In-house Data
Engineers at Northwestern developed the AI model using clinical data within the university’s own network, emphasizing that such tools can be created without assistance from other organizations.
“Our study shows that building custom AI models is well within reach of a typical health system, without reliance on expensive and opaque third-party tools like ChatGPT,” Etemadi noted.
The Journal of the American College of Radiology states the supply of radiologists is expected to increase by approximately 26% over the next 30 years. However, the need for radiologists is expected to grow between 17% and 27% over the same period. Becker’s Hospital Review reports there will be a shortage of up to 42,000 radiologists in the US by 2033.
Some health organizations are using a mixed model of permanent employees and contracted radiologists to meet the increasing demand for services. Others are also looking at options such as internal training programs, better benefits for workers, teleradiology, and remote radiologists to fulfill radiology needs.
“You still need a radiologist as the gold standard,” Abboud said. “Medicine changes constantly—new drugs, new devices, new diagnoses—and we have to make sure the AI keeps up. Our role becomes ensuring every interpretation is right for the patient.”
Can pathology practices and clinical laboratories learn from radiology’s situation? Development of AI solutions for those fields would likely have similar effects on workloads and overworked personnel.
Exploring the benefits of AI may be one way of helping meet clinical laboratory and pathology practice staff shortages.
Industry commenters point to a void since the federal government shuttered the Clinical Laboratory Improvement Advisory Committee
For readers wondering what has happened to the Clinical Laboratory Improvement Advisory Committee (CLIAC), the bottom line is the panel has been terminated, causing a significant void for the lab industry at the federal level.
Dark Daily’s sibling brands, including The Dark Report, G2 Intelligence, and Today’s Clinical Lab, have been exploring various aspects about the demise of CLIAC.
The Centers for Disease Control and Prevention (CDC) confirmed to G2 Intelligence that CLIAC was terminated as of March 31, citing an executive order from President Donald Trump intended to reduce federal advisory committees. The decision blindsided even those closest to CLIAC. Incoming committee chairman Jordan Laser, MD, revealed in an email to colleagues that he did not have more insight into CLIAC’s demise beyond media reports, G2 reported.
Since its founding in 1992, CLIAC has played an influential—though non-regulatory—role in shaping updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The committee brought together pathologists, lab directors, public health leaders, and representatives from federal agencies such as the CDC, Centers for Medicare and Medicaid Services, and Food and Drug Administration.
The federal government’s decision to eliminate CLIAC “risks stalling progress in laboratory medicine, which could ultimately hinder efforts to improve patient care,” CAP President Donald Karcher, MD, FCAP, told The Dark Report. (Photo copyright: College of American Pathologists.)
‘Critical Venue’ for Labs Has Been Eliminated
Industry groups are sounding alarms about what comes next. In an interview with Today’s Clinical Lab, Anthony Killeen, MD, PhD, president of the Association for Diagnostics and Laboratory Medicine (ADLM), said CLIAC was an important forum for medical lab scientists to discuss CLIA.
“[CLIAC] served as a critical venue for working through current problems with the rule and also for expert input on how new technologies—such as next-generation sequencing, digital pathology, and artificial intelligence-assisted diagnostics—should be assessed and integrated under CLIA,” Killeen said.
ADLM has formally urged Department of Health and Human Services Secretary Robert F. Kennedy, Jr. to reverse the CLIAC decision. In a May letter, the association emphasized that CLIAC’s work was funded entirely through user fees paid by clinical laboratories rather than taxpayer dollars—a point many in the lab industry say underscores CLIAC’s value.
CAP President Wonders about Future Communication Gaps
The Dark Report noted that the disbanding of CLIAC may cost labs time in certain cases, a commodity that few diagnostic settings have in abundance.
“The absence of this advisory body may lead to gaps in communication and slower response times in addressing [industry] challenges,” Donald Karcher, MD, FCAP, president of the College of American Pathologists (CAP), told The Dark Report.
The absence of CLIAC raises uncertainty for clinical labs because federal agencies have lost a prime source to gather specialized input on complex scientific and operational issues facing the lab industry. Dark Daily’s partner brands will continue to track this matter closely. If you’re not a subscriber, you can check out The Dark Report’s insider coverage with a 14-day free trial.
Pharmaceutical and biotech researchers convened last week to discuss their latest work on targeting neurodegenerative diseases
With all the news this year alone on progress being made with diagnostic testing for Alzheimer’s disease, clinical laboratory professionals will be interested to know that drug discovery efforts to combat neurogenerative diseases are also at a heightened pitch.
Last week at the one-day Neuroimmunology in Drug Discovery forum in Boston, scientists learned about the latest advances in therapeutic research to better treat Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease. As the treatments advance, demand for them will increase, which goes hand-in-hand with medical lab testing to detect signs of these illnesses.
The concern is urgent. The US Food and Drug Administration (FDA) noted that 10% of people age 65 and older have Alzheimer’s disease, and that number could double by 2050. The FDA recently cleared the first in vitro diagnostics device that tests blood to diagnose Alzheimer’s, and other IVD manufacturers and clinical labs are working on other Alzheimer’s tests, Dark Daily reported.
“It’s looking quite promising for NLRP3 inhibitors,” said Cheryl Leyns, PhD, associate principal scientist in discovery neuroscience at Merck Research Laboratories, in discussing how mutations of the NLRP3 protein can lead to neurodegenerative diseases. (Photo copyright: ELRIG.)
Much of the discussion at the Neuroimmunology in Drug Discovery forum centered on the idea that neuroinflammation—in other words, inflammation of the brain or spinal cord—starts well before neurodegenerative diseases arise. Neuroinflammation can accelerate Parkinson’s disease and other neurodegenerative disorders, said Cheryl Leyns, PhD, associate principal scientist, neuroimmunology, at Merck Research Laboratories in Boston, who spoke at the event.
From that perspective, drug discovery researchers are on the prowl for these early signs of future problems.
Leyns discussed NLRP3, a protein that aids the body’s inflammation process. A mutation of NLRP3 can lead to inflammatory problems, making the protein a prime target for researchers. “We have been interested, in the biopharma space, in the potential of NLRP3 inhibitors,” she noted.
Older Immune Systems Are Susceptible
While many in the public correctly associate Alzheimer’s with a person being outwardly older, a lesser-known aspect is that the body’s immune system also ages, becoming more susceptible over time to chronic inflammation.
Wailings’ assertion was not rhetorical. She pointed to numbers which showed scholarly research that involved the terms “inflammation,” “neurodegeneration,” and “aging” was only about 17% of the total amount of journal articles that addressed the first two terms, but which did not include “aging.”
As the pharmaceutical, biotech, and medical fields move aggressively forward to defend people against neurodegenerative diseases like Alzheimer’s, clinical laboratory scientists should take comfort that diagnostic testing trends are solidly in the mix.
Therapeutic advances, along with increased options for testing, show promising signs that patients and their caregivers will have more tools to use in the battle against these illnesses.
Genetic test that analyzes DNA to identify men at greatest risk for developing the disease could become common clinical laboratory screen for cancer
Researchers in the UK believe a common spit test can be more accurate at determining which men are more likely to develop prostate cancer than the clinical laboratory prostate-specific antigen (PSA) blood test currently used by the National Health Service (NHS) for that diagnosis.
During a recent study, scientists at the Institute of Cancer Research, London (ICR), found that germline DNA extracted from saliva, which was then used to derive polygenic risk scores for cancer, resulted in a higher percentage of participants “found to have clinically significant disease” than the percentage that would have been identified with the use of PSA or MRI.
The salvia test works by analyzing men’s DNA to find out if they are genetically pre-disposed to developing the disease. Men who find out they are likely to develop prostate cancer can then pursue further testing and scans.
“The test assesses 130 genetic variants to provide a risk score for prostate cancer, which is the second most common cause of cancer deaths in men in the UK,” The Guardian reported.
The study found that 187 of the men in the study had prostate cancer. According to the American Cancer Society, one in eight men will be diagnosed with prostate cancer in their lifetime.
“We can identify men at risk of aggressive cancers who need further tests and spare the men who are at lower risk from unnecessary treatments,” said study leader Rosalind Eeles, PhD, of the ICR London, in The Guardian.
“With this test, it could be possible to turn the tide on prostate cancer,” Rosalind Eeles, PhD, of the Institute of Cancer Research, London, told the BBC. (Photo copyright: Prostate Cancer UK.)
Landmark Discovery
Michael Inouye, PhD, professor of systems genomics and population health at the University of Cambridge, told the BBC that researchers will look back on this study “as a landmark.” He also acknowledged that it would be a long road before widespread implementation of the test.
While some sources call the ICR’s test promising, they also acknowledge it may only have a modest effect and that there may be possible racial disparities in the findings. The study was primarily based on people with European ancestry. According to Prostate Cancer UK, black men in the UK have double the risk of developing the disease. A similar trend can be observed in the US, Statistica reported.
Dusko Ilic, PhD, professor in stem cell sciences at King’s College London, told the BBC that there was “no direct evidence” of these findings having an effect on survival or quality of life. He stressed the need for more studies to better assess the value of the test.
The salvia test is expected to be included in Prostate Cancer UK’s TRANSFORM trial, a $58 million research program partly funded by the NHS to determine the best way to screen for cancer in the UK.
Effect on Clinical Pathologists
Prostate cancer is expected to surge in the US over the next 15 years, according to UC Davis Health. Thus, pathologists should expect more men to seek ways to assess their risk. Pathologists would be wise to educate themselves fully on new and emerging tests and tools to best meet the needs of their patients.
Given the publicity generated by former President Biden’s announcement that he has an advanced case of prostate cancer, clinical laboratories should also expect more patients to request diagnostic tests that either screen for or confirm the presence of the disease.
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test measures blood biomarkers associated with the disease
Clinical laboratories could soon find themselves playing a significant role in Alzheimer’s care as the US Food and Drug Administration (FDA) announced its first-ever clearance of a blood test to assist in diagnosing the cognitive disease.
The agency issued a 510(k) clearance for the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test from Fujirebio Diagnostics, Inc. The test is intended for “the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease,” according to an FDA press release.
“Nearly seven million Americans are living with Alzheimer’s disease, and this number is projected to rise to nearly 13 million,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, MD, PhD, in the press release. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease.”
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, MD, MPH, in the FDA press release.
“Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients,” said FDA Commissioner Martin A. Makary, MD, MPH, in the FDA press release. (Photo copyright: Johns Hopkins University.)
Blood Protein Test Details
Fujirebio’s test calculates the ratio of two blood proteins, pTau217 and β-amyloid 1-42. “This ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan,” the press release states.
The FDA said it has already authorized or cleared similar tests that use cerebrospinal fluid (CSF) samples obtained through an invasive spinal tap. “This new Lumipulse test only requires a simple blood draw, making it less invasive and much easier for patients to access,” the FDA said.
In granting the clearance, the agency looked at data from a clinical study of 499 adults displaying signs of cognitive impairment. Close to 92% of participants with positive test results had amyloid plaques as determined by amyloid PET scan or CSF test results. Approximately 97% with negative results from the Lumipulse test were also shown to be negative in the PET scan or CSF test. Fewer than 20% of the patients received indeterminate results, which would require additional testing.
The primary risks of the test are false positive or false negative results, the federal agency noted.
“Importantly, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is not intended as a screening or stand-alone diagnostic test and other clinical evaluations or additional tests should be used for determining treatment options,” the FDA said.
‘Wild West’ Marketplace
In their reporting of this story,MedPage Today and the Associated Press both noted that some laboratory-developed tests can already measure plasma biomarkers associated with Alzheimer’s.
“But those tests aren’t reviewed by the FDA and generally aren’t covered by insurance,” the AP reported. “Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a ‘wild west.’”
Neurologist Richard S. Isaacson, MD, told CNN that he’s already using the test for research purposes. “It can provide better clarity into whether a person experiencing memory loss may have Alzheimer’s disease,” he said.
However, he cautioned that more research is needed to allow doctors to make best use of the test.
“I think the next step as a field is, we need to advance education about what these tests mean and what they don’t and who they should be used for,” he told CNN. “Because they mean different things in different people depending on their risk factors and whether they have symptoms. So, we’re still early.”
“The results must be interpreted in conjunction with other patient clinical information,” the FDA acknowledged in their press release.
Other Alzheimer’s Tests
The FDA said it reviewed the Lumipulse test through the 510(k) premarket notification pathway, in which the federal agency determines if a device is “substantially equivalent to a legally marketed predicate device.”
In this case, the agency found that the test is substantially equivalent to Fujirebio’s Lumipulse G β-amyloid Ratio (1-42/1-40), which measures the same proteins in CSF samples. The FDA authorized that device in 2022, according to a Fujirebio press release. That test uses Fujirebio’s automated Lumipulse G1200 instrument system.
Other companies including Roche, Eli Lilly, and C2N Diagnostics are also developing Alzheimer’s tests they intend to submit for FDA review, the AP reported.
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.”
