News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

World Economic Forum Publishes Updated List of 12 Breakthroughs in Fight against Cancer That Includes Innovative Clinical Laboratory Test (Part 1)

List also includes precision oncology, liquid biopsies, and early diagnosis of pancreatic cancer

Pathologists and clinical laboratory managers will be interested to learn that in a recently updated article the World Economic Forum (WEF) identified a dozen important recent breakthroughs in the ongoing fight to defeat cancer, including some related to pathology and clinical laboratory diagnostics.

The article noted that approximately 10 million people die each year from cancer. “Death rates from cancer were falling before the pandemic,” the authors wrote. “But COVID-19 caused a big backlog in diagnosis and treatment.”

The Swiss-based non-profit is best known for its annual meeting of corporate and government leaders in Davos, Switzerland. Healthcare is one of 10 WEF “centers” focusing on specific global issues.

Here are four advances identified by WEF that should be of particular interest to clinical laboratory leaders. The remaining advances will be covered in part two of this ebrief on Wednesday.

“Our study represents a major leap in cancer screening, combining the precision of protein-based biomarkers with the efficiency of sex-specific analysis,” said Novelna founder and CEO Ashkan Afshin, MD, ScD (above), in a company press release. “We’re not only looking at a more effective way of detecting cancer early but also at a cost-effective solution that can be implemented on a large scale.” The 12 breakthroughs listed in the World Economic Forum’s updated article will likely lead to new clinical laboratory screening tests for multiple types of cancer. (Photo copyright: Novelna.)

Novelna’s Early-Stage Cancer Test

Novelna, a biotech startup in Palo Alto, Calif., says it has developed a clinical laboratory blood test that can detect 18 early-stage cancers, including brain, breast, cervical, colorectal, lung, pancreatic, and uterine cancers, according to a press release.

In a small “proof of concept” study, scientists at the company reported that the test identified 93% of stage 1 cancers among men with 99% specificity and 90% sensitivity. Among women, the test identified 84% of stage 1 cancers with 85% sensitivity and 99% specificity.

The scientists published their study titled, “Novel Proteomics-based Plasma Test for Early Detection of Multiple Cancers in the General Population,” in the journal BMJ Oncology.

The researchers collected plasma samples from 440 individuals diagnosed with cancers and measured more than 3,000 proteins. They identified 10 proteins in men and 10 in women that correlated highly with early-stage cancers.

“By themselves, each individual protein was only moderately accurate at picking up early stage disease, but when combined with the other proteins in a panel they were highly accurate,” states a BMJ Oncology press release.

The company says the test can be manufactured for less than $100.

“While further validation in larger population cohorts is necessary, we anticipate that our test will pave the way for more efficient, accurate, and accessible cancer screening,” said Novelna founder and CEO Ashkan Afshin, MD, ScD, in the company press release.

Precision Oncology

According to the National Institutes of Health’s “Promise of Precision Medicine” web page, “Researchers are now identifying the molecular fingerprints of various cancers and using them to divide cancer’s once-broad categories into far more precise types and subtypes. They are also discovering that cancers that develop in totally different parts of the body can sometimes, on a molecular level, have a lot in common. From this new perspective emerges an exciting era in cancer research called precision oncology, in which doctors are choosing treatments based on the DNA signature of an individual patient’s tumor.”

This breakthrough is enabled by the emergence of next generation sequencing (NGS), wrote Genetron Health co-founder and CEO Sizhen Wang in a WEF blog post.

“These advanced sequencing technologies not only extend lifespans and improve cure rates for cancer patients through application to early screening; in the field of cancer diagnosis and monitoring they can also assist in the formulation of personalized clinical diagnostics and treatment plans, as well as allow doctors to accurately relocate the follow-up development of cancer patients after the primary treatment,” Wang wrote.

Based in China, Genetron Health describes itself as a “leading precision oncology platform company” with products and services related to cancer screening, diagnosis, and monitoring.

Liquid and Synthetic Biopsies

Liquid biopsies, in which blood or urine samples are analyzed for presence of biomarkers, provide an “easier and less invasive” alternative to conventional surgical biopsies for cancer diagnosis, the WEF article notes.

These tests allow clinicians to “pin down the disease subtype, identify the appropriate treatment and closely track patient response, adjusting course, if necessary, as each case requires—precision medicine in action,” wrote Merck Group CEO Belén Garijo, MD, in an earlier WEF commentary.

The WEF article also highlighted “synthetic biopsy” technology developed by Earli, Inc., a company based in Redwood City, Calif.

As explained in a Wired story, “Earli’s approach essentially forces the cancer to reveal itself. Bioengineered DNA is injected into the body. When it enters cancer cells, it forces them to produce a synthetic biomarker not normally found in humans.”

The biomarker can be detected in blood or breath tests, Wired noted. A radioactive tracer is used to determine the cancer’s location in the body.

The company hopes to begin clinical trials at the end of 2025, Genetic Engineering and Biotechnology News reported.

Early Diagnosis of Pancreatic Cancer

“Pancreatic cancer is one of the deadliest cancers,” the WEF article notes. “It is rarely diagnosed before it starts to spread and has a survival rate of less than 5% over five years.”

The WEF article authors highlighted an experimental blood test developed at the University of California San Diego School of Medicine.

The test is based on a technology known as high-conductance dielectrophoresis (DEP), according to a UC San Diego press release. “It detects extracellular vesicles (EVs), which contain tumor proteins that are released into circulation by cancer cells as part of a poorly understood intercellular communication network,” the press release states. “Artificial intelligence-enabled protein marker analysis is then used to predict the likelihood of malignancy.”

The UC San Diego researchers reported the results from their first clinical test of the technology in the journal Communications Medicine titled, “Early-Stage Multi-Cancer Detection Using an Extracellular Vesicle Protein-based Blood Test.”

The test detected 95.5% of stage 1 pancreatic cancers, 74.4% of stage 1 ovarian cancers, and 73.1% of pathologic stage 1A lethally aggressive serous ovarian adenocarcinomas, they wrote.

“These results are five times more accurate in detecting early-stage cancer than current liquid biopsy multi-cancer detection tests,” said co-senior author Scott M. Lippman, MD.

Look to Dark Daily’s ebrief on Wednesday for the remainder of breakthroughs the World Economic Forum identifies as top advancements in the fight to defeat cancer.

—Stephen Beale

Related Information:

Novelna Inc. Announces Groundbreaking Cancer Screening Test: A Major Step Toward Early Detection and Personalized Healthcare

Novel Proteomics-based Plasma Test for Early Detection of Multiple Cancers in the General Population

Precision Oncology: Who, How, What, When, and When Not?

Six Experts Reveal the Technologies Set to Revolutionize Cancer Care

Beyond Liquid Biopsies: How the Synthetic Biopsy Leads the Next Generation of Early Cancer Detection

A Proactive Way to Detect Cancer at Its Earliest Stages

Earli Detection: “Synthetic” Biomarkers Light Up Hidden Malignant Cancers

New Technique Detects 95% of Early-Stage Pancreatic Cancer

New Screening Tool IDs 95% of Stage 1 Pancreatic Cancer

Scientists Make DNA Discovery That Could Help Find Pancreatic Cancer Cure

Pancreatic Cancer Turns Off a Key Gene in Order to Grow

Early-Stage Multi-Cancer Detection Using an Extracellular Vesicle Protein-Based Blood Test

Promoter Methylation Leads to Hepatocyte Nuclear Factor 4A Loss and Pancreatic Cancer Aggressiveness

Pathology Laboratory Cuts Lead to Worker Walkout in Australia

Underfunding of clinical laboratories has led to similar worker walkouts in multiple Australasian nations

Once again, cuts in government spending on pathology services has forced healthcare workers to walk off the job in Australia. This is in line with other pathology doctor and clinical laboratory workers strikes in New Zealand and other Australasian nations over the past few years.

Announcement of a planned closure of the pathology laboratory at 30-bed Cootamundra Hospital in Australia to make room for expanding the emergency department spurred the health worker walkouts.

“Health staff from Cootamundra Hospital, alongside pathology workers from Deniliquin, Tumut, Griffith, Wagga Wagga, and Young will rally in front of their respective facilities” to draw attention to the effect closing the lab would have on critical healthcare services across those areas, Region Riverina reported.

The strikes are drawing attention to unfair pay and poor working conditions that underfunding has brought to the state-run healthcare systems in those nations. They also highlight how clinical laboratories worldwide are similarly struggling with facility closings, unfair pay, and unachievable workloads.

“The proposed closure of Cootamundra’s pathology lab is a short-sighted decision that will have far-reaching consequences for patient care in the region,” NSW Health Services Union (HSU) Secretary Gerard Hayes (above) told Region Riverina. Similar arguments have been made for years concerning the underfunding, pay disparities, and poor working conditions in New Zealand’s government-run clinical laboratories and pathology practices that has led to worker strikes there as well. (Photo copyright: HSU.)

Australia Pathology Lab Closure Stokes Fears

Cootamundra Hospital’s strike was spurred by a planned closure of its pathology laboratory. In May, employees learned of the plans to close the lab as well as surgery and birthing centers to accommodate expansion of the emergency department, Region Riverina reported.

“Pathology workers are already in short supply and this move could see us lose highly skilled professionals from the NSW Health system altogether,” New South Wales (NSW) Health Services Union (HSU) Secretary Gerard Hayes told Region Riverina.

The cuts would not only be detrimental to the area, it would significantly affect patient care, he added.

“This lab is not just profitable; it’s a vital lifeline for Cootamundra Hospital’s [surgical] theater lists and maternity unit,” he said. “Without this lab, patients will face significantly longer wait times for life-saving diagnostic information. This delay could severely impact our ability to provide timely care, especially in emergencies.”

Echoing those sentiments, HSU Union Official Sam Oram told Region Riverina that closing the Cootamundra Hospital lab would put pressure on labs in Wagga and Young and would continue a trend of closing smaller pathology labs. Oram, who organizes for members in Canberra and Murrumbidgee Local Health District, noted that smaller labs in Tumut and Deniliquin could be in danger as well.

“Why should people living in rural and regional areas have fewer and inferior services to Australians living in metropolitan areas?” Michael McCormack, MP, Federal Member for Riverina and former deputy prime minister of Australia, asked Parliament in June, Region Riverina reported. “There’s no right or proper answer to that question. They simply should not,” he added.

Tasmania’s Troubles

Medical scientists recently walked off the job at Launceston General Hospital in Tasmania, Australia, to protest “the government’s ‘inaction’ on recruiting more staff,” according to Pulse Tasmania. The hospital’s lab has a staff shortage of 17 employees, requiring the remaining staff members to handle a much increased workload, Ryan Taylor, a medical laboratory scientist with the Tasmanian Department of Health, told Pulse Tasmania.

“This shortfall is leading to significant and unacceptable challenges … which are causing the Tasmanian community from receiving vital test results that are essential for their health,” Lucas Digney, Industrial Champion, Health and Community Services Union (HACSU) leader, told Pulse Tasmania.

New Zealand Struggles with Its Healthcare Workers

Aotearoa, as New Zealand is known by its indigenous Polynesian population, also struggles with health worker walkouts.

“Medical labs are an essential organ of the health system. Many were stupidly privatized years ago, others still operate within Te Whatu Ora [aka Health New Zealand, the publicly funded healthcare system] with all the resource shortages and stress that go with that,” Newsroom said of the country’s plight in 2023. “There was a view that competition in medical labs would produce greater efficiency, but it has actually produced a mess.”

Dark Daily has covered the ongoing strife in New Zealand’s clinical laboratories over many years. Previous ebriefs highlighted how the strikes were causing delays in critical clinical laboratory blood testing and surgical procedures.

In “New Zealand Blood Service Workers and Junior Doctors Hit the Picket Line Once Again to Fight against Pay Disparities and Poor Working Conditions,” we covered how after seven months of failed negotiations, New Zealand’s blood workers, clinical laboratory technicians, and medical scientists, again went on strike in May with another walkout planned for June.

In “Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand,” we reported on a medical laboratory worker strike in New Zealand’s South Island and Wellington regions where workers walked off the job after a negotiated agreement was not reached between specialist union APEX and Awanui Labs, one of the country’s largest hospital and clinical laboratory services providers.

And in “Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions,” we covered walkouts in 2022 sparked by an unprecedented surge in PCR COVID-19 testing that pushed the country’s 10,000 healthcare workers—including 4,000 medical laboratory scientists and technicians—to the breaking point.

Underfunding in clinical laboratories continues to cause work stoppages in the Australasian countries. But as Dark Daily readers know, it is a growing problem among European nations and in the United States as well.

—Kristin Althea O’Connor

Related Information:

NZ’s Health Lab Staff Deserve Better than Failed Private Leadership

Stop-Work Action Planned by Health Workers to Protest Pathology Lab Cuts

‘It’s Simply Not Good Enough’: McCormack Slams Planned Cuts to Cootamundra Hospital Maternity Services

Launceston General Hospital Medical Science Staff Walk Out over ‘Critical Understaffing Issues’

Pathologists Fear Sector Collapse without Urgent Change

Awanui Lab Workers Head Back to Bargaining Table

Lab Workers Go for Pay Parity

ECG Management Consultants Survey Determines US Patients Wait an Average of 38 Days for Care

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.”

—Kristin Althea O’Connor

Related Information:

The 38-day Delay: What the Wait Time Average Says about Healthcare Access

The Waiting Game: New-Patient Appointment Access for US Physicians

In the US, Wait Times to See a Doctor Can Be Agonizingly Long

Canadian Health Care Leaves Patients Frozen In Line

Tenfold Rise in A&E Patients Waiting More than 24 Hours for a Bed

European Researchers Discover Gut Bacteria That Can Help Create Universal O-Type Blood

Should further study validate these findings, clinical laboratories managing hospital blood banks would be among the first to benefit from an abundance of universal donor blood

In a surprising outcome for microbiome research, scientists at the Technical University of Denmark (DTU) and Sweden’s Lund University discovered that the bacteria Akkermansia muciniphila, which resides in the human gut, produces enzymes that can be used to process whole blood in ways that could help produce type-O blood. This “universal” blood type can be given to patients during transfusions when other blood types are in short supply.

Receiving the wrong type of blood via a transfusion could result in a fatal reaction where the immune system launches an attack on foreign antigens. As blood bankers and clinical laboratory scientists know, the A antigens in type A blood are not compatible with the B antigens in type B blood. Type-O blood completely lacks these antigens, which explains why it can be used for individuals of any blood type. 

The DTU/Lund discovery—still in its initial stages of development—could eventually give blood bankers in hospital laboratories a way to expand their supply of universal type-O blood. Although individuals with type-O blood are universal donors, often the available supply is inadequate to meet the demand.

“For the first time, the new enzyme cocktails not only remove the well-described A and B antigens, but also extended variants previously not recognized as problematic for transfusion safety,” said Maher Abou Hachem, PhD, Professor of Biotechnology and Biomedicine at DTU, one of the authors of the study, in a news release.

Discovering a way that ensures any blood type can donate blood for all blood types could increase the supply of donor blood while reducing the costs and logistics affiliated with storing four separate blood types. Additionally, the production of a universal blood type using gut microorganisms could reduce the waste associated with blood products nearing their expiration dates. 

Whole blood must be used within 42 days after being collected. Having more units of the universal donor blood type would be extremely beneficial in how blood banks manage their blood supply and may revolutionize transfusions. The scientists published their findings in the journal Nature Microbiology titled, “Akkermansia Muciniphila Exoglycosidases Target Extended Blood Group Antigens to Generate ABO-Universal Blood.”

“We are close to being able to produce universal blood from group B donors, while there is still work to be done to convert the more complex group A blood,” said Maher Abou Hachem, PhD (above), Professor of Biotechnology and Biomedicine at DTU in a news release. “Our focus is now to investigate in detail if there are additional obstacles and how we can improve our enzymes to reach the ultimate goal of universal blood production,” he added. Hospital clinical laboratories that manage blood banks will be among the first to benefit from this new process once it is developed and cleared for use in patient care. (Photo copyright: Technical University of Denmark.)

Creating Universal Donor Blood

The bacterium Akkermansia muciniphila is abundant in the guts of healthy humans. It produces valuable compounds, and it is able to break down mucus in the gut and can have significant, positive effects on body weight and metabolic markers.

“What is special about the mucosa is that bacteria, which are able to live on this material, often have tailor-made enzymes to break down mucosal sugar structures, which include blood group ABO antigens. This hypothesis turned out to be correct,” Hachem noted in the DTU news release.

“Instead of doing the work ourselves and synthesizing artificial enzymes, we’ve asked the question: What looks like a red [blood] cell surface? The mucus in our gut does. So, we simply borrowed the enzymes from the bacteria that normally metabolize mucus and then applied them to the red [blood] cells,” Martin Olsson MD, PhD, professor of hematology and transfusion medicine at Lund University, told Live Science. “If you think about it, it’s quite beautiful.”

The researchers successfully identified long strings of sugar structures known as antigens that render one blood type incompatible with another. These antigens define the four blood types: A, B, AB and O. They then used a solution of gut bacteria enzymes to remove the sugar molecules present on the surface of red blood cells (RBCs).

“We biochemically evaluated 23 Akkermansia glycosyl hydrolases and identified exoglycosidase combinations which efficiently transformed both A and B antigens and four of their carbohydrate extensions,” the study authors wrote in Nature Microbiology. “Enzymatic removal of canonical and extended ABO antigens on RBCs significantly improved compatibility with group O plasmas, compared to conversion of A or B antigens alone. Finally, structural analysis of two B-converting enzymes identified a previously unknown putative carbohydrate-binding module.”

“Universal blood will create a more efficient utilization of donor blood, and also avoid giving ABO-mismatched transfusions by mistake, which can otherwise lead to potentially fatal consequences in the recipient. When we can create ABO-universal donor blood, we will simplify the logistics of transporting and administering safe blood products, while at the same time minimizing blood waste,” Olsson said in the news release.

Future Progress

The researchers have applied for a patent for the enzymes and their method of enzyme treatment. The two educational institutions hope to make further progress on this joint project over the next three years. They eventually hope to test their theory in controlled patient trials and make it available for commercial production and clinical use.

More research and clinical studies are needed to prove the effectiveness of this discovery. Clinical laboratory professionals—particularly those who manage hospital blood banks—will want to follow DTU’s research. It could someday lead to the availability of a more abundant supply of universal donor blood for transfusions.

—JP Schlingman

Related Information:

Akkermansia Muciniphila Exoglycosidases Target Extended Blood Group Antigens to Generate ABO-universal Blood

Enzymes Open New Path to Universal Donor Blood

Gut Bacteria Can Help Create Artificial Group O Blood

Lab-made Universal Blood Could Revolutionize Transfusions. Scientists Just Got One Step Closer to Making It

Universal Donor Blood Significantly Closer Thanks to Enzymes Found in Gut Bacteria

A Gut Bacteria Could Hold the Key to Universal Blood, Revolutionizing Transfusion Medicine

How Gut Enzymes Could Make Universal Donor Blood Possible

Iranian Study Shows Staggering Carcinogenic Risk in Hospital Laboratories from Occupational Exposure to Deadly Chemicals

Study found highest incidences of occupational carcinogenesis among clinical laboratory and histology technicians, followed by pathologists

It has been known for years that formalin (a form of formaldehyde used as a disinfectant and preservative in the handling of tissues samples in anatomy, pathology, and microbiology labs), as well as xylene and toluene, are dangerous to clinical laboratory workers. Nations around the world have taken steps to minimize exposure to these dangerous chemicals. However, a recent study in Iran found that those measures may not have gone far enough to protect histology and clinical laboratory technicians, pathologists, and medical laboratory scientists.

The study conducted by researchers in the Department of Occupational Health Engineering, School of Public Health, at Tehran University of Medical Sciences, showed that levels of exposure to these chemicals is still significantly higher than recommended, resulting in a higher risk for cancer among lab workers in Iran’s hospitals.

The scientists published their findings in the journal Nature Scientific Reports titled, “Occupational Exposure, Carcinogenic and Non-Carcinogenic Risk Assessment of Formaldehyde in the Pathology Labs of Hospitals in Iran.”

“Employing risk assessment techniques as a complementary tool in monitoring programs for respiratory exposure in the different work setting should be considered to protect the staffs against both non-cancerous and cancer-related hazards,” the study authors wrote.

Lessons learned from the Iranian hospital lab study could benefit clinical laboratory workers in US hospitals and help those who work with formaldehyde, toluene, and xylene worldwide to reduce their chances of developing a vascular condition known as Raynaud’s phenomenon (shown above) which can lead to necrosis and gangrene, as well as other dangerous health conditions affecting the lungs, brain, and other systems and organs in the body. (Photo copyright: Wikipedia.)

Study Details

The Iranian study considered the carcinogenic and non-carcinogenic impact of occupational exposure to formaldehyde in the pathology laboratories of four Tehran hospitals. The researchers “used a quantitative risk assessment method proposed by the United States Environmental Protection Agency (EPA), along with its provided database known as the Integrated Risk Information System (IRIS). Respiratory symptoms were assessed using the American Thoracic Society (ATS) questionnaire,” the study authors wrote in Nature Scientific Reports.

The scientists found that “91.23% of exposure levels in occupational groups exceed the NIOSH [National Institute for Occupational Safety and Health] standard of 0.016 ppm.” They determined that “41.03% of all the studied subjects were in the definite carcinogenic risk range (LCR > 10−4), 23.08% were in the possible carcinogenic risk range (10−5 < LCR < 10−4), and 35.90% were in the negligible risk range (LCR < 10−6),” they wrote.

“The highest index of occupational carcinogenesis was observed in the group of lab technicians with a risk number of 3.7 × 10-4, followed by pathologists with a risk number of 1.7 × 10-4,” the scientists wrote. “Furthermore, 23.08% of the studied subjects were within the permitted health risk range (HQ < 1.0), while 76.92% were within the unhealthy risk range (HQ > 1.0),” they added.

“Formaldehyde exhibits high solubility in water and is rapidly absorbed by the nasal cavity, sinuses, throat, and mucous membrane of the upper respiratory tract upon exposure,” the study authors wrote. “Consequently, due to the elevated potential for both carcinogenic and non-carcinogenic formaldehyde exposure among pathology staff—particularly laboratory technicians—the implementation of management measures … becomes imperative to lower the exposure levels of all employees below permissible limits.”

Those management measures include:

  • “Strict guideline adherence and safe work protocols,
  • “Increasing staff numbers to decrease exposure duration,
  • “Adoption of engineering solutions such as localized ventilation systems, and
  • “Use of respiratory protective equipment during sample handling and tissue processing.”

Previous Reports on Exposure Risk to Clinical Lab Workers

The knowledge of the danger behind these chemicals isn’t new.

In “National Academy of Sciences Confirms That Formaldehyde Can Cause Cancer in a Finding That Has Implications for Anatomic Pathology and Histology Laboratories,” Dark Daily covered how, in 2011, the US Department of Health and Human Services (HHS) National Toxicology Program’s (NTP) “Report on Carcinogens” was the first instance where formaldehyde was upgraded to “known to be a human carcinogen.”

In 2017, a pathology lab in Auckland, New Zealand, lost its accreditation because formaldehyde levels were so high the lab had to be evacuated nearly every day, The New Zealand Herald reported.

And in “Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene,” we reported on a 2011 study conducted in Wellington, New Zealand, that linked exposure to these chemicals with increased auto immune connective tissue diseases, notably doubling likelihood of developing Raynaud’s phenomenon.

“In epidemiological studies on industrial workers, pathologists and anatomists, the relationship between exposure to formaldehyde and an increased risk of various types of cancer including nasal cavity, nasopharynx, lung, brain, pancreas, prostate, colon and atopic lymphoma system has been determined,” the Iranian scientists wrote in Nature Scientific Reports.

Call for Stronger Regulations

“The Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Environmental Protection Agency have expressed serious concern about the carcinogenicity of formaldehyde,” the Iranian scientists noted, adding that “the potential carcinogenic risk to humans has been studied in a number of cohort and case-control studies.”

There is room for more studies looking at the health effects of exposure to these chemicals among lab workers, as well as continued evaluation of the risks and preventative measures that could be taken. Perhaps tightened regulations will make its way to US labs, echoing more stringent ones of the European Union.

“It is imperative to implement control measures across various hospital departments to mitigate occupational formaldehyde exposure levels proactively. These findings can be valuable for policymakers in the health sector, aiding in the elimination or reduction of airborne formaldehyde exposure in work environments,” the Iranian scientists wrote.

Managers of histology and clinical laboratories may find useful advice in hospital laboratory studies like that coming out of Iran. Protecting the health of lab workers worldwide starts with reducing their exposure to deadly chemicals.

—Kristin Althea O’Connor

Related Information:

Occupational Exposure, Carcinogenic and Non-Carcinogenic Risk Assessment of Formaldehyde in the Pathology Labs of Hospitals in Iran

National Academy of Sciences Confirms That Formaldehyde Can Cause Cancer in a Finding That Has Implications for Anatomic Pathology and Histology Laboratories

Pathology Lab Loses Accreditation Because of High Levels of Formaldehyde

Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene

NTRL Report on Carcinogens. Twelfth Edition, 2011

Scathing Report from Former Health Minister Finds England’s NHS Plagued by Long Wait Times, Crumbling Infrastructure

Declining health of UK’s population also affecting performance of the country’s national health service, report notes

England’s National Health Service (NHS) is “in serious trouble” due to long waiting times, outdated technology, misallocated resources, and numerous other problems, with dire consequences for the country’s populace. That’s according to a new report by NHS surgeon and former Health Minister Lord Ara Darzi, OM KBE FRS FMedSci HonFREng, who was tasked by the United Kingdom’s new Labor government to investigate the ailing healthcare system. His report may contain lessons for US healthcare—including clinical laboratories—as well.

“Although I have worked in the NHS for more than 30 years, I have been shocked by what I have found during this investigation—not just in the health service but in the state of the nation’s health,” Darzi stated in a UK government press release. “We want to deliver high quality care for all but far too many people are waiting for too long and in too many clinical areas, quality of care has gone backwards.”

Many of the problems he identified relate to wait times.

“From access to GPs (general practitioners) and to community and mental health services, on to accident and emergency, and then to waits not just for more routine surgery and treatment but for cancer and cardiac services, waiting time targets are being missed,” he wrote in his report.

For example, “as of June 2024, more than one million people were waiting for community services, including more than 50,000 people who had been waiting for over a year, 80% of whom are children and young people,” he wrote.

Accident and emergency care (A/E) “is in an awful state,” the report noted, “with A/E queues more than doubling from an average of just under 40 people on a typical evening in April 2009 to over 100 in April 2024. One in 10 patients are now waiting for 12 hours or more.”

“In the last 15 years, the NHS was hit by three shocks—austerity and starvation of investment, confusion caused by top-down reorganization, and then the pandemic which came with resilience at an all-time low. Two out of three of those shocks were choices made in Westminster,” said NHS surgeon and former Health Minister Lord Ara Darzi in a government press release. “It took more than a decade for the NHS to fall into disrepair so it’s going to take time to fix it. But we in the NHS have turned things around before, and I’m confident we will do it again.” (Photo copyright: Health Data Research UK.)

Delays in Other Critical Tests

Genetic test results are lagging as well. “In 2024, more than 35,000 genomic tests are being completed each month but only around 60% on time,” Darzi wrote.

He also noted that “only around 5% of eligible patients with brain cancer are able to access whole genome sequencing (WGS), which is important for treatment selection.” Just two-thirds (65.8%) get their first treatment within 62 days, and more than 30% wait more than 31 days for radical radiotherapy, according to the report.

Overall, “the UK has appreciably higher cancer mortality rates than other countries, with no progress whatsoever made in diagnosing cancer at stage one and two between 2013 and 2021,” he wrote.

Patients have also experienced delays in access to cardiovascular treatment. For example, in 2013-2014, high-risk heart attack patients waited an average of 114 minutes for intervention to unblock an artery, Darzi noted in his report. However, in 2022-2023, the average time was 146 minutes, a 28% increase.

“For the most part, once people are in the system, they receive high quality care,” he wrote. “But there are some important areas of concerns, such as maternity care, where there have been a succession of scandals and inquiries.”

Key Factors Leading to Delays

Darzi pointed to four key factors that have led to the problems.

Lack of funding. “The 2010s was the most austere decade since the NHS was founded, with spending growing at around 1% in real terms,” Darzi wrote, compared with a long-term average of 3.4%.

One result was that administrators took funds from the capital budget to cover day-to-day needs, leading to “crumbling buildings that hit productivity,” he noted.

“The backlog maintenance bill now stands at more than £11.6 billion and a lack of capital means that there are too many outdated scanners, too little automation, and parts of the NHS are yet to enter the digital era,” he wrote.

The COVID-19 pandemic. Given the preceding “decade of austerity,” NHS had fewer resources to deal with the crisis than most other high-income health systems, he wrote. As a result, NHS “delayed, cancelled, or postponed far more routine care during the pandemic than any comparable health system.” This led to “a bigger backlog than other health systems.”

Lack of patient and staff engagement. Patient satisfaction “has declined and the number of complaints has increased, while patients are less empowered to make choices about their care,” he wrote. In addition, “too many staff have become disengaged, and there are distressingly high-levels of sickness absence—as much as one working month a year for each nurse and each midwife working in the NHS.”

Management structures and systems. Darzi laid considerable blame on the UK’s Health and Social Care Act of 2012, which led to what he described as “a costly and distracting process of almost constant reorganization of the ‘headquarters’ and ‘regulatory’ functions of the NHS.”

One consequence, he wrote, is that too many clinicians have been deployed in hospitals instead of community-based care, despite years of promises by successive governments to put more emphasis on the latter.

National Health in Decline

Along with issues within the NHS, “the health of the nation has deteriorated and that impacts its performance,” Darzi wrote. “There has been a surge in multiple long-term conditions, and, particularly among children and young people, in mental health needs. Fewer children are getting the immunizations they need to protect their health, and fewer adults are participating in some of the key screening programs, such as for breast cancer.”

Darzi’s investigation included frontline visits to NHS facilities as well as focus groups with NHS staff and patients, the press release states. He also consulted an expert reference group consisting of more than 70 organizations and examined analyses from NHS England, the UK’s Department of Health and Social Care, and external groups.

It is interesting that there is no mention of anatomic pathology and medical laboratory testing services in Lord Darzi’s report. As reported in recent years by new outlets in the United Kingdom, delays in cancer diagnoses—often as long as six months—were severe enough that, in 2018, the NHS announced funding for a program to create a national digital pathology network to improve productivity of pathologists and shorten wait times for the results of cancer tests.

—Stephen Beale

Related Information:

The NHS Is in ‘Serious Trouble’ and Needs Major Reform – Here Are the Pitfalls the Government Must Avoid

‘Major Surgery, Not Sticking Plaster Solutions’ Needed to Rebuild NHS

Independent Investigation of the National Health Service in England

No Extra NHS Funding without Reform, Says PM

No More Money for NHS Without Reform, Says Starmer As He Outlines Vision for Health Service

Long NHS Delays in England Leading to Thousands of Unnecessary Deaths, Inquiry Finds

NHS Is Broken but No Extra Funding without Reform, Starmer Says

The Left Must Accept NHS Reform or It Will Die, Says Streeting

Welsh and UK Government to Co-Operate on NHS Reform

Keir Starmer Says UK’s NHS Needs to ‘Reform or Die’

Welsh NHS Needs Reform, Keir Starmer Says

;