Clinical laboratories can play a role in educating and advising at-home self-collection test users
Women are twice as likely to follow through with cervical cancer screening when they receive a self-collection kit for HPV infection rather than a reminder phone call from a clinical laboratory. That’s according to research conducted at University of Texas MD Anderson Cancer Center.
Human papillomavirus (HPV) causes nearly all types of cervical cancer. In their study, the researchers found that 41% of women pursued cancer screening when given a self-collection kit as opposed to 17% who only received a telephone reminder.
According to a University of Texas press release, MD Anderson conducted its study between February 2020 and August 2023 and included 2,500 women from the Houston area between the ages of 30-65. Most of the women (94%) were racial or ethnic minorities, and 56% of the participants received help from a publicly funded financial assistance program. More than 80% of the women in the self-collection groups returned their self-collection kits.
“As self-collection tests become available in the US, it’s vital that we gather data to guide how they are rolled out. We want to make sure that they become available in clinics and health centers that care for people who often have the hardest time accessing healthcare,” said Jane Montealegre, PhD, associate professor in the Department of Behavioral Science, Division of Cancer Prevention and Population Sciences at the University of Texas.
“By removing barriers, we are hopeful that we can improve the uptake of evidence-based screening tests and make significant progress against this preventable disease,” said Jane Montealegre, PhD, associate professor in the Department of Behavioral Science, Division of Cancer Prevention and Population Sciences at the University of Texas, in the press release. (Photo copyright: University of Texas.)
Comfortable Alternative to Pap Smears
At-home cervical cancer screening tests are becoming more popular as opposed to the Pap smear, a gynecological procedure that can be painful or uncomfortable for some patients.
In May, Teal Health announced it had received FDA approval to distribute its Teal Wand, the first at-home cervical cancer screening self-collection device commercially available, according to G2 Intelligence, a sibling publication to Dark Daily.
The turnaround time for the test is about one week, Teal spokesperson Lilly Bromberg told G2. Results are reported in a secure patient portal. Teal clinicians will schedule a follow-up with any patient who has abnormal results to explore future steps.
Option for Demographics More Likely to Develop Cervical Cancer
These self-collection tests could also reach patients who are unable to access care. “Too many women—especially those who are uninsured, live in rural areas, or come from marginalized and underserved communities—aren’t getting screened for cervical cancer,” said Montealegre.
Cervical cancer affects nearly 13,000 women annually, and racial disparities exist amongst those affected. According to the American Journal of Preventative Medicine, black women in America are 30% more likely to develop cervical cancer, and 60% of them are more likely to die of the disease, than non-Hispanic white women. Hispanic women have a 51% higher chance of developing cervical cancer than non-Hispanic white women.
At-home screening may be a crucial next step in closing the gaps in care and further driving down the rates of cervical cancer. The findings of this study show how the convenience and ease of these tests may be able to bring at-risk women closer to diagnosis and treatment of cervical cancer.
As newly approved self-collection tests become more popular, there may be a growing market for clinical laboratory professionals to advise at-home test users on their functionality and the results they return. Self-collection testing may increase in years to come because of these advances.
Device provides physicians with quick insights into infant’s immune system capabilities without requiring clinical laboratory testing
International researchers have developed a revolutionary tool that rapidly assesses an infant’s immune system using a single drop of blood. The novel device provides healthcare professionals with real-time insights about a newborn’s immune response in less than 15 minutes.
Scientists from the Singapore-MIT Alliance for Research and Technology (SMART) in collaboration with colleagues from KK Women’s and Children’s Hospital (KKH) in Singapore created the Biophysical Immune Profiling for Infants (BLIPI) portable device to help alleviate potentially life-threatening illnesses in newborns. The device only uses 0.05 ml of blood.
The work was led by researchers from the Critical Analytics for Manufacturing Personalized Medicine (CAMP) and Antimicrobial Resistance (AMR) interdisciplinary research groups within SMART. SMART is a major research collaboration between the Massachusetts Institute of Technology (MIT) and the National Research Foundation of Singapore.
“BLIPI represents a major step forward by providing clinicians with fast, actionable immune health data using a noninvasive method, where it can make a real difference for newborns in critical care,” said Kerwin Kwek Zeming, PhD, research scientist at SMART CAMP and SMART AMR, and co-lead author of the study, in an MIT news release.
“Our goal was to create a diagnostic tool that works within the unique constraints of neonatal care—minimal blood volume, rapid turnaround, and high sensitivity,” said Kerwin Kwek Zeming, PhD, research scientist at SMART CAMP and SMART AMR, and co-lead author of the MIT study, in the news release. (Photo copyright: MIT.)
Bridging Gap between Science and Healthcare
To perform their study, the team used BLIPI to screen 19 infants—eight full-term and 11 preterm—and compared the differences in immune cells between the infants. The device uses microfluidic technology to measure immune cell characteristics, such as size and flexibility, to expose how the immune system is responding to changes within the cells. Traditional tests look only for the presence of germs, but BLIPI also looks at results such as C-reactive protein levels, white blood cell counts, and immature-to-total neutrophil ratios, to determine if an infant is fighting an infection.
“BLIPI exemplifies our vision to bridge the gap between scientific innovation and clinical need. By leveraging microfluidic technologies to extract real-time immune insights from whole blood, we are not only accelerating diagnostics but also redefining how we monitor immune health in fragile populations,” said Jongyoon Han, PhD, professor of electrical engineering and biological engineering at MIT and coauthor of the paper, in the news release. “Our work reflects a new paradigm in point-of-care diagnostics: rapid, precise, and patient-centric.”
Saving Infant Lives
BLIPI only needs one tiny drop of blood, which equals 1/20 of the blood volume typical lab tests require. The onsite tool removes the need for sending blood samples to clinical labs, which may enable clinicians to make earlier decisions regarding treatment options for critical situations like sepsis or necrotizing enterocolitis.
“KKH cares for about two-thirds of all babies born weighing less than 1,500 grams (52.91 ounces or 3.31 pounds) in Singapore. These premature babies often struggle to fight infections with their immature immune systems. With BLIPI, a single prick to the baby’s finger or heel can give us rapid insights into the infant’s immune response within minutes. This allows us to tailor treatments more precisely and respond faster to give these fragile babies the best chance at a healthy start not just in their early days, but throughout their lives,” said Yeo Kee Thai, MD, senior consultant in the department of neonatology at KKH, and senior author of the study, in the news release.
BLIPI also could be extremely beneficial to healthcare settings in remote areas or with limited resources.
Further research and clinical trials are needed to validate the diagnostic accuracy of BLIPI. In addition, the researchers plan to improve the design to render it usable for widespread distribution. They also hope BLIPI will someday be used by pharmaceutical companies and medical researchers to evaluate immune responses to neonatal therapies in real time.
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.
