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Clinical Laboratories and Pathology Groups

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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

Washington University Researchers Uses Medical Laboratory Test Results and Big Data to Find Accelerated Aging and Risk of Early Cancer in Young Adults

Study shows that computer analysis of clinical laboratory test results has improved greatly in recent years

Studies using “big data” continue to show how combining different types of healthcare information can generate insights not available with smaller datasets. In this case, researchers at Washington University School of Medicine (WashU Medicine), St. Louis, Mo., determined that—by using the results from nine different types of clinical laboratory tests—they could correlate those test results to younger people who had “aged faster” and had developed cancer earlier than usual, according to CNN.

“Accumulating evidence suggests that the younger generations may be aging more swiftly than anticipated, likely due to earlier exposure to various risk factors and environmental insults. However, the impact of accelerated aging on early-onset cancer development remains unclear,” said Ruiyi Tian, PhD candidate at WashU Medicine’s Yin Cao Lab in an American Association for Cancer Research (AACR) news release.

The scientists presented their findings, which have not yet been published, at the AACR’s annual meeting held in April. Tian and the other researchers “hypothesized that increased biological age, indicative of accelerated aging, may contribute to the development of early-onset cancers, often defined as cancers diagnosed in adults younger than 55 years. In contrast to chronological age—which measures how long a person has been alive—biological age refers to the condition of a person’s body and physiological processes and is considered modifiable,” AACR noted in a news release.

“We all know cancer is an aging disease. However, it is really coming to a younger population. So, whether we can use the well-developed concept of biological aging to apply that to the younger generation is a really untouched area,” Yin Cao, ScD MPH (above), associate professor of surgery and associate professor of medicine at Washington University School of Medicine in St. Louis, and senior author of the study, told CNN. Analysis of clinical laboratory test results using computer algorithms continues to show value for new research into deadly diseases. (Photo copyright: Washington University.)

Lab Tests Share Insights about Aging

To acquire the data they needed for their research, the WashU Medicine scientists turned to the UK Biobank, a biomedical and research resource with genetic and health information on half a million UK residents.

The researchers reviewed the medical records of 148,724 biobank participants, age 37 to 54, focusing on nine blood-based biomarkers that “have been shown to correlate with biological age,” CNN reported. Those biomarkers are:

According to CNN, the researchers “plugged” the nine values into an algorithm called PhenoAge. Using the algorithm they compared the biological ages with each person’s actual chronological age to determine “accelerated aging.” They then consulted cancer registries to capture data on those in the study who were diagnosed with cancer before age 55. They found 3,200 cases.

Young Adults Aging Faster than Earlier Generations

According to the AACR news release, the WashU Medicine study found that:

  • “Individuals born in or after 1965 had a 17% higher likelihood of accelerated aging than those born between 1950 and 1954.
  • “Each standard deviation increase in accelerated aging was associated with a 42% increased risk of early-onset lung cancer, a 22% increased risk of early-onset gastrointestinal cancer, and a 36% increased risk of early-onset uterine cancer.
  • “Accelerated aging did not significantly impact the risk of late-onset lung cancer (defined here as cancer diagnosed after age 55), but it was associated with a 16% and 23% increased risk of late-onset gastrointestinal and uterine cancers, respectively.”

“We speculate that common pathways, such as chronic inflammation and cellular senescence, may link accelerated aging to the development of early-onset cancers,” the study’s principal investigator Yin Cao, ScD, MPH, associate professor of surgery and associate professor of medicine at WashU Medicine, told The Hill.

“Historically, both cancer and aging have been viewed primarily as concerns for older populations. The realization that cancer, and now aging, are becoming significant issues for younger demographics over the past decades was unexpected,” Tian told Fox News.

More Screenings, Further Analysis

The study’s results may suggest a change in clinical laboratory screenings for younger people.

“We see cancers earlier all the time now, and nobody knows why. The subset in the population that has accelerated aging may need screening more often or earlier,” Emanuela Taioli, MD, PhD, professor of population health and science and of thoracic surgery, and director of the Institute for Translational Epidemiology, Icahn School of Medicine at Mount Sinai, told Health.

In future studies, WashU Medicine scientists may aim to include groups of greater diversity and explore why people are aging faster and have risk of early-onset cancers. 

“There is room to improve using better technologies. Looking at the bigger picture, the aging concept can be applied to younger people to include cancers, cardiovascular disease, and diabetes,” Cao told Discover Magazine.

While more research is needed, use of the UK’s Biobank of healthcare data—including clinical laboratory test results—enabled the WashU Medicine researchers to determine that accelerated aging among young adults is happening with some regularity. This shows that capabilities in computer analysis are gaining more refined capabilities and are able to tease out insights impossible to achieve with earlier generations of analytical software.

These findings should inspire clinical laboratory professionals and pathologists to look for opportunities to collaborate in healthcare big data projects involving their patients and the communities they serve.

—Donna Marie Pocius

Related Information:

Accelerated Aging May Increase the Risk of Early-onset Cancers in Younger Generations

Accelerated Aging Linked to Cancer Risk in Younger Adults, Research Shows

An Epigenetic Biomarker of Aging for Lifespan and Health Span in Aging

Accelerated Aging May be a Cause of Increased Cancers in People under 55

Cancer Rates Rising in Young People Due to “Accelerated Aging,” New Study Finds

Research Shows Accelerated Aging Linked to Increased Cancer Risk in Younger Adults

Rate of Biological Aging is Accelerating in Young People, Leading to Medical Issues

ECRI Study Finds Errors During Testing Processes Are Responsible for Most Diagnostic Errors

Researchers note that many sources of errors associated with diagnostic testing involve how providers order tests and how specimens are handled

ECRI (Emergency Care Research Institute), a non-profit organization that focuses on healthcare quality and patient safety, has released results from a study which lays blame for most diagnostic errors on systemic issues that arise during clinical laboratory, radiology, and other diagnostic testing processes. These issues relate to “ordering, collecting, processing, obtaining results, or communicating results,” the organization stated in a news release.

“It’s a common misconception that if a patient has a missed or incorrect diagnosis, their doctor came up with the wrong hypothesis after having all the facts,” said ECRI President and CEO Marcus Schabacker MD, PhD, in the news release. “That does happen occasionally, but we found that was tied to less than 3% of diagnostic errors. What’s more likely to break the diagnostic process are technical, administrative, and communication-related issues. These represent system failures, where many small mistakes lead to one big mistake.”

The researchers based their analysis on reports of adverse patient safety events and “near-misses” submitted to ECRI and the Institute for Safe Medication Practices (ISMP) in 2023. Healthcare providers submitted the data from across the US, ECRI noted.

From a total of 3,014 patient safety events, ECRI determined that 1,011 were related to diagnostic errors. Then, it sorted the events based on “the appropriate step in the diagnostic process where the breakdown occurred,” according to the news release.

ECRI did not reveal how many errors were related to clinical laboratory testing as opposed to radiological or ultrasound imaging.

“The problem of diagnostic safety comes down to the lack of a systems-based approach,” said ECRI President and CEO Marcus Schabacker MD, PhD (above), in a news release. “Since there are multiple potential failure points, a single intervention is insufficient.” Diagnostic errors can also include imaging/radiology and other types of diagnostic procedures—not just clinical laboratory tests. (Photo copyright: ECRI.)

Where Errors Occur

According to ECRI’s analysis, the largest number of errors by far (nearly 70%) happened during the clinical laboratory testing process. Among these, “more than 23% were a result of a technical or processing error, like the misuse of testing equipment, a poorly processed specimen, or a clinician lacking the proper skill to conduct the test,” ECRI stated. “Another 20% of testing errors were a result of mixed-up samples, mislabeled specimens, and tests performed on the wrong patient.”

Outside the testing process, other errors occurred during monitoring and follow-up (12%) and during referral and consultation (9%).

One major factor behind diagnostic errors, ECRI noted, was miscommunication among providers and between providers and patients.

The organization also cited “productivity pressures that prevent providers from exploring all investigative options or from consulting other providers” as leading to diagnostic errors.

In some cases, providers who ordered lab tests delayed reviewing the results or the patients were not notified of the results.

“Referrals to specialists or requests for additional consultations can complicate the process, presenting more potential failure points,” ECRI noted.

Troubling Imaging Anecdotes, Previous Studies

The ECRI news release cites two de-identified patient stories, both related to imaging. One case involved a woman who “experienced abdominal pain and abnormal vaginal bleeding,” but a diagnosis of uterine cancer was delayed nearly a year. “MRIs were ordered, but not all the results were reviewed, as her symptoms worsened. Despite masses being detected on an ultrasound, a missed appointment and communication barriers delayed her diagnosis. She was finally diagnosed after severe pain led to hospitalization.”

In one “near-miss” incident, a patient did not receive an essential carotid ultrasound procedure prior to being scheduled for open-heart surgery. Staff caught the omission and canceled the surgery. A later ultrasound “revealed he would have had a catastrophic surgical outcome if the surgery had proceeded as scheduled,” ECRI stated.

Two earlier studies noted in the news release highlight the impact of diagnostic errors.

A 2017 study, published in the journal BMJ Quality Safety, estimated that diagnostic errors affect approximately 5% of US adults—a total of 12 million—each year. In that paper, the authors combined estimates from three observational studies that defined diagnostic error in similar ways.

“Based upon previous work, we estimate that about half of these errors could potentially be harmful,” the authors wrote.

And a 2024 study published in the same journal estimated that 795,000 Americans die or become permanently disabled each year due to misdiagnosis of dangerous diseases. “Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined,” the authors wrote.

Recommendations for Providers, Labs

ECRI advised that healthcare providers should adopt a “total systems safety approach and human-factors engineering” to reduce diagnostic errors. This is good advice for clinical laboratories as well.

Specific steps should include “integrating EHR workflows, optimizing testing processes, tracking results, and establishing multidisciplinary diagnostic management teams to analyze safety events,” the news release states.

Schabacker also advised patients to “ask questions to understand why their doctor is ordering tests, and are those tests urgent,” he said. “Schedule your appointments and tests quickly and follow up with your provider if you’re awaiting results. If possible, ask a family member or friend to join you in important appointments, to help ask questions and take notes.”

Clinical laboratory managers have been alerted to the involvement of lab testing in incidents of medical errors. This report by ECRI is more evidence of the gaps in care delivery that often contribute to medical error. Medical lab professionals may want to review the ECRI report to learn more about what the authors identify as the specific breakdowns in care processes that contribute to medical errors.

—Stephen Beale

Related Information:

Data Analysis Reveals Common Errors That Prevent Patients from Getting Timely, Accurate Diagnoses

Nearly 70% of Diagnostic Errors Occur During Testing: ECRI

Errors within the Total Laboratory Testing Process, from Test Selection to Medical Decision-Making – A Review of Causes, Consequences, Surveillance and Solutions

Burden of Serious Harms from Diagnostic Error in the USA

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