These advances in the battle against cancer could lead to new clinical laboratory screening tests and other diagnostics for early detection of the disease
As Dark Daily reported in part one of this story, the World Economic Forum (WEF) has identified 12 new breakthroughs in the fight against cancer that will be of interest to pathologists and clinical laboratory managers.
As we noted in part one, the WEF originally announced these breakthroughs in an article first published in May 2022 and then updated in October 2024. According to the WEF, the World Health Organization (WHO) identified cancer as a “leading cause of death globally” that “kills around 10 million people a year.”
The WEF is a non-profit organization base in Switzerland that, according to its website, “engages political, business, academic, civil society and other leaders of society to shape global, regional and industry agendas.”
Monday’s ebrief focused on four advances identified by WEF that should be of particular interest to clinical laboratory leaders. Here are the others.
Personalized Cancer Vaccines in England
The National Health Service (NHS) in England, in collaboration with the German pharmaceutical company BioNTech, has launched a program to facilitate development of personalized cancer vaccines. The NHS Cancer Vaccine Launch Pad will seek to match cancer patients with clinical trials for the vaccines. The Launch Pad will be based on messenger ribonucleic acid (mRNA) technology, which is the same technology used in many COVID-19 vaccines.
The BBC reported that these cancer vaccines are treatments, not a form of prevention. BioNTech receives a sample of a patient’s tumor and then formulates a vaccine that exposes the cancer cells to the patient’s immune system. Each vaccine is tailored for the specific mutations in the patient’s tumor.
“I think this is a new era. The science behind this makes sense,” medical oncologist Victoria Kunene, MBChB, MRCP, MSc (above), trial principal investigator from Queen Elizabeth Hospital Birmingham (QEHB) involved in an NHS program to develop personalized cancer vaccines, told the BBC. “My hope is this will become the standard of care. It makes sense that we can have something that can help patients reduce their risk of cancer recurrence.” These clinical trials could lead to new clinical laboratory screening tests for cancer vaccines. (Photo copyright: Queen Elizabeth Hospital Birmingham.)
Seven-Minute Cancer Treatment Injection
NHS England has also begun treating eligible cancer patients with under-the-skin injections of atezolizumab, an immunotherapy marketed under the brand name Tecentriq, Reuters reported. The drug is usually delivered intravenously, a procedure that can take 30 to 60 minutes. Injecting the drug takes just seven minutes, Reuters noted, saving time for patients and cancer teams.
The drug is designed to stimulate the patient’s immune system to attack cancer cells, including breast, lung, liver, and bladder cancers.
AI Advances in India
One WEF component—the Center for the Fourth Industrial Revolution (C4IR)—aims to harness emerging technologies such as artificial intelligence (AI) and virtual reality. In India, the organization says the Center is seeking to accelerate use of AI-based risk profiling to “help screen for common cancers like breast cancer, leading to early diagnosis.”
Researchers are also exploring the use of AI to “analyze X-rays to identify cancers in places where imaging experts might not be available.”
Using AI to Assess Lung Cancer Risk
Early-stage lung cancer is “notoriously hard to detect,” WEF observed. To help meet this challenge, researchers at Massachusetts Institute of Technology (MIT) developed an AI model known as Sybil that analyzes low-dose computed tomography scans to predict a patient’s risk of getting the disease within the next six years. It does so without a radiologist’s intervention, according to a press release.
Using Genomics to Identify Cancer-Causing Mutations
In what has been described as the “largest study of whole genome sequencing data,” researchers at the University of Cambridge in the UK announced they have discovered a “treasure trove” of information about possible causes of cancer.
Using data from England’s 100,000 Genomes Project, the researchers analyzed the whole genome sequences of 12,000 NHS cancer patients.
This allowed them “to detect patterns in the DNA of cancer, known as ‘mutational signatures,’ that provide clues about whether a patient has had a past exposure to environmental causes of cancer such as smoking or UV light, or has internal, cellular malfunctions,” according to a press release.
The researchers also identified 58 new mutational signatures, “suggesting that there are additional causes of cancer that we don’t yet fully understand,” the press release states.
The study appeared in April 2022 in the journal Science.
Validation of CAR-T-Cell Therapy
CAR-T-cell therapy “involves removing and genetically altering immune cells, called T cells, from cancer patients,” WEF explained. “The altered cells then produce proteins called chimeric antigen receptors (CARs), which can recognize and destroy cancer cells.”
The therapy appeared to receive validation in 2022 when researchers at the University of Pennsylvania published an article in the journal Nature noting that two early recipients of the treatment were still in remission after 12 years.
However, the US Food and Drug Administration (FDA) announced in 2023 that it was investigating reports of T-cell malignancies, including lymphoma, in patients who had received the treatment.
WEF observed that “the jury is still out as to whether the therapy is to blame but, as a precaution, the drug packaging now carries a warning.”
Breast Cancer Drug Repurposed for Prevention
England’s NHS announced in 2023 that anastrozole, a breast cancer drug, will be available to post-menopausal women to help reduce their risk of developing the disease.
“Around 289,000 women at moderate or high risk of breast cancer could be eligible for the drug, and while not all will choose to take it, it is estimated that if 25% do, around 2,000 cases of breast cancer could potentially be prevented in England, while saving the NHS around £15 million in treatment costs,” the NHS stated.
The tablet, which is off patent, has been used for many years to treat breast cancer, the NHS added. Anastrozole blocks the body’s production of the enzyme aromatase, reducing levels of the hormone estrogen.
Big Advance in Treating Cervical Cancer
In October 2024, researchers announced results from a large clinical trial demonstrating that a new approach to treating cervical cancer—one that uses currently available therapies—can reduce the risk of death by 40% and the risk of relapsing by 36%.
“This is the biggest improvement in outcome in this disease in over 20 years,” said Mary McCormack, PhD, clinical oncologist at the University College London and lead investigator in the trial.
The scientists published their findings in The Lancet.
Pathologists and clinical lab managers will want to keep track of these 12 breakthrough advancements in the diagnosis and treatment of cancer highlighted by the WEF. They will likely lead to new screening tests for the disease and could save many lives.
Clinical laboratory executives and pathology leaders may want to develop strategies for supporting the growing numbers of at-home screening and diagnostic test users
Findings of a national poll conducted by the University of Michigan (U-M) exploring consumers’ purchases suggests seniors are becoming more comfortable with ordering and using at-home medical testing. Their choice of tests and opinions may be of interest to clinical laboratory executives, pathologists, and primary care physicians considering programs to support self-test purchasers.
The researchers found that 48% of adults, ages 50 to 80, purchased at least one at-home medical test, and that 91% of the buyers indicated intentions to purchase another test in the future, according to a U-M news release.
In their paper, they note that “validity, reliability, and utility of at-home tests is often uncertain.” Further, understanding and responding to test results—especially since caregivers may not have ordered them—could lead to “a range of unintended consequences,” they wrote.
“As a primary care doctor, I would want to know why my patient chose to take an at-home test that I didn’t order for them. We also need to understand in greater detail why folks use at-home tests instead of traditional means, beyond convenience,” said the U-M study’s lead author Joshua Rager, MD, a research scientist at William M. Tierney Center for Health Services Research at Regenstrief Institute, who is now an assistant professor of medicine, Indiana University, in a news release. The findings of the U-M study will be of interest to clinical laboratory executives and pathology leaders. (Photo copyright: Regenstrief Institute.)
Free COVID-19 Tests Ignite At-Home Testing
In their Journal of Health Care paper, the U-M researchers speculate that curiosity in at-home testing may have been propelled by the offer of free COVID-19 tests by the US government starting in 2021 during the pandemic.
They also noted the different ways at-home test kits are performed by healthcare consumers. Some, such as COVID-19 rapid antigen tests, return results to users in a few moments similar to pregnancy tests. Others involve self-collecting specimens, such as a stool sample, then sending the specimen to a clinical laboratory for analysis and results reporting to physicians.
Of those older adults who participated in U-M’s National Poll on Healthy Aging study, the following bought at-home medical tests online or from pharmacies and supermarkets, according to U-M’s paper:
As to perceptions of at-home medical testing by users, when polled on their test experience, the surveyed seniors reported the following:
75.1% perceived at-home medical tests to be more convenient than conventional medical tests.
59.9% believe the tests “can be trusted to give reliable results.”
54.8% believe the tests “are regulated by government.”
66% called them a “good value.”
93.6% indicated results “should be discussed with my doctor.”
Inconsistency in how people shared test results with their healthcare providers was a concern voiced by the researchers.
“While nearly all patients who had bought an at-home cancer screening test shared the results with their primary care provider, only about half of those who tested for an infection other than COVID-19 had. This could have important clinical implications,” the researchers wrote in their paper.
Confusion over Government Regulation
The U-M study also revealed consumer misunderstanding about government regulation of at-home clinical laboratory tests purchased over-the-counter.
The US Food and Drug Administration (FDA) cleared “some diagnostic at-home tests for over-the counter use. But many tests on the market are unregulated or under-regulated,” the authors wrote, adding, “Our results suggest, however, that patients generally believe at-home tests are regulated by government, but a substantial minority did not, which may reflect public confusion in how at-home testing is regulated.”
Women, College-Educated Buy More At-Home Tests
Purchase of at-home tests varies among groups, as follows, the news release noted:
56% and 61% of older adults with a college degree or household income above $100,000, respectively, were “much more likely” to buy at-home tests than people in other income and education brackets.
87% of women would buy at-home tests again compared with 76% of men.
89% of college-educated people would purchase the tests again, compared with 78% of people with high school educations or less.
Future U-M research may explore consumers’ awareness/understanding concerning federal regulations of at-home testing, Rager noted.
“At-home tests could be used to address disparities in access to care. We hope these findings will inform regulators and policymakers and spark future research on this topic,” he said in the news release.
The U-M Institute for Healthcare Policy and Innovation survey results confirm that the country’s senior generations are becoming comfortable with at-home and self-testing options. As Dark Daily has previously suggested, clinical laboratories may want to develop service offerings and a strategy for supporting patients who want to perform their own lab tests at home.
“Previously … CDC developed tests for emerging pathogens and then shared those tests with others, and then after that, commercial labs would develop their own tests,” Shah told CNN. “That process took time. Now with these new arrangements, commercial labs will be developing new tests for public health responses alongside CDC, not after CDC.”
In a news release announcing the contract, ARUP Laboratories also characterized the move as a shift for the agency.
“The new contract formalizes ARUP’s relationship with the CDC,” said Benjamin Bradley, MD, PhD, medical director of the ARUP Institute for Research and Innovation in Infectious Disease Genomic Technologies, High Consequence Pathogen Response, Virology, and Molecular Infectious Diseases. “We continue to expand our capabilities to address public health crises and are prepared to scale up testing for H5N1, or develop other tests quickly, should the need arise.”
“To be clear, we have no evidence so far that this [bird flu] virus can easily infect human beings or that it can spread between human beings easily in a sustained fashion,” Jennifer Nuzzo, DrPH (above), Director of the Pandemic Center and Professor of Epidemiology at Brown University School of Public Health, told CNN. “If it did have those abilities, we would be in a pandemic.” Clinical laboratory leaders will recall the challenges at the CDC as it developed its SARS-CoV-2 test early in the COVID-19 pandemic. (Photo copyright: Brown University.)
Missouri Case Raises Concerns
The first human infection of HPAI was reported in late March following a farmer’s “exposure to dairy cows presumably infected with bird flu,” the CDC stated in its June 3, 2024, bird flu Situation Summary. That followed confirmation by the USDA’s Animal and Plant Health Inspection Service (APHIS) of an HPAI outbreak in commercial poultry flocks in February 2022, and the CDC’s confirmation of the first known infections in dairy herds reported on March 25, 2024.
Concerns about the outbreak were heightened in September following news that a person in Missouri had been infected with the virus despite having no known contact with infected animals. CNN reported that it was the 14th human case in the US this year, but all previous cases were in farm workers known to be exposed to infected dairy cattle or poultry.
In a news release, the Missouri Department of Health and Senior Services (DHSS) revealed that the patient, who was not identified, was hospitalized on Aug. 22. This person had “underlying medical conditions,” DHSS reported, and has since recovered and was sent home. Both DHSS and the CDC conducted tests to determine that the virus was the H5 subtype, the news release states.
At present, the CDC states that the public health risk from the virus is low. However, public health experts are concerned that risks could rise as the weather gets cooler, creating opportunities for the virus to mutate “since both cows and other flu viruses will be on the move,” CNN reported.
Concerns over CDC Testing and FDA Oversight
In the months immediately following the first human case of the bird flu virus, Nuzzo was among several public health experts sounding an alarm about the country’s ability to ramp up testing in the face of new pathogens.
“We’re flying blind,” she told KFF Health News in June, due to an inability to track infections in farmworkers. At that time, tests had been distributed to approximately 100 public health labs, but Nuzzo and other experts noted that doctors typically order tests from commercial laboratories and universities.
KFF reported that one diagnostics company, Neelyx Labs, ran into obstacles as it tried to license the CDC’s bird flu test. Founder, CEO, and lead scientist Shyam Saladi, PhD, told KFF that the federal agency had promised to cooperate by facilitating a license and a “right to reference” CDC data when applying for FDA authorization but was slow to come through.
While acknowledging the need for testing accuracy, Greninger contended that the CDC was prioritizing caution over speed, as it did in the early days of the COVID-19 pandemic. “The CDC should be trying to open this up to labs with national reach and a good reputation,” he told KFF.
Another problem, KFF reported, related to the FDA’s new oversight of laboratory developed tests (LDTs), which is causing labs to move cautiously in developing their own tests.
Jennifer Nuzzo, DrPH (above), Director of the Pandemic Center and Professor of Epidemiology at the Brown University School of Public Health co-authored a June 2024 analysis in Health Affairs that called on the CDC to develop “a better testing playbook for biological emergencies.” The authors’ analysis cited earlier problems with the responses to the COVID-19 and mpox (formerly known as monkeypox) outbreaks.
If global surveillance networks have detected a novel pathogen, the authors advise, the US should gather information and “begin examining the existing testing landscape” within the first 48 hours.
Once the pathogen is detected in the US, they continued, FDA-authorized tests should be distributed to public health laboratories and the CDC’s Laboratory Response Network (LRN) laboratories within 48 hours.
Advocates of this approach suggest that within the first week diagnostics manufacturers should begin developing their own tests and the federal government should begin working with commercial labs. Then, within the first month, commercial laboratories should be using FDA-authorized tests to provide “high throughput capacity.”
This may be good advice. Experts in the clinical laboratory and healthcare professions believe there needs to be improvement in how novel tests are developed and made available as novel infectious agents are identified.
Discovery could lead to new treatments for cancer and tumors, but probably not to any new diagnostic assays for clinical laboratories
Researchers at the University of Texas Southwestern (UTSW) Medical Center have reported discovery of “acid walls” that appear to protect various types of cancer tumors from attack by the body’s immune system cells. Though the discovery is not directly related to a biomarker for a clinical laboratory diagnostic test, the basic research will help scientists develop ways to address the tumor’s acid wall strategy for defeating the immune system.
The UT scientists made their discovery using an internally developed imaging technique that employs nanoparticle probes to detect levels of acidity in cells. The research, they suggest, “could pave the way for new cancer treatment approaches that alter the acidic environment around tumors,” according to a UTSW press release.
“This study revealed a previously unrecognized polarized extracellular acidity that is prevalent around cancer cells,” said lead study author Jinming Gao, PhD (above), Professor in the Harold C. Simmons Comprehensive Cancer Center and head of the Gao Lab at UT Southwestern Medical Center, in a press release. Gao believes the study “will lead to several new lines of research, such as studies to better understand how cancer cells polarize their acid excretion, how those cells can withstand the acidity level that kills CD8+ T cells, and how to inhibit acid excretion to allow T cells to better kill cancer cells,” the press release notes. (Photo copyright: University of Texas.)
Developing Acid Walls
As explained in the press release, scientists have long known that cancer cells are slightly more acidic than most healthy tissue. Gao and his team designed a nanoparticle known as pegsitacianine—a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery—that disassembles and lights up when exposed to the acidic conditions in tumors.
However, “it was unclear why these nanoparticles fluoresced since a tumor’s acidity was thought to be too mild to trigger their activation,” the press release note.
To learn more, they used nanoparticle probes to illuminate a variety of individual cancer cells sampled from humans and mice, including lung, breast, melanoma, and glioblastoma, as well as tumor tissue. They discovered that the cancer cells secreted lactic acid—a waste product of digested glucose—at higher levels than previously known. The cells “pumped” the acid away from their malignant neighbors to form a protective “acid wall” around the tumor, the researchers noted in Nature Biomedical Engineering.
“Samples from human tumors showed that this acid wall was practically devoid of CD8+ T cells within the tumors, an immune cell type known to fight cancer,” the press release states. “When the researchers grew cancer cells and CD8+ T cells together in petri dishes that had been acidified to a 5.3 pH, the cancer cells were spared while the CD8+ T cells perished within three hours, suggesting that this severe acidity might thwart immune cell attack without harming the cancer cells.”
Gao’s team previously discovered that sodium lactate, the “conjugate base of lactic acid” as they describe it, increases the longevity of T cells and thus enhances their cancer-fighting capabilities. The researchers described the two molecules—lactate and lactic acid—as “Dr. Jekyll and Mr. Hyde,” and suggested that future therapies could seek to convert lactic acid to lactate.
“Gao noted that this discovery will lead to several new lines of research, such as studies to better understand how cancer cells polarize their acid excretion, how those cells can withstand the acidity level that kills CD8+ T cells, and how to inhibit acid excretion to allow T cells to better kill cancer cells,” the press release states.
Commercializing the Technology
Pegsitacianine was designed to aid cancer surgeons by illuminating the edges of solid metastatic tumors in real time during surgery, a 2023 UTSW Medical Center press release explains. About 24 hours prior to surgery, nanoprobes are delivered via IV. Then, the surgeon uses a near-infrared camera to visualize the cells.
UTSW has licensed pegsitacianine to OncoNano Medicine, a Dallas-area biotech startup launched to commercialize technologies from Gao Lab. Gao and his colleague Baran Sumer, MD, Professor and Chief of the Division of Head and Neck Oncology in UT Southwestern Medical Center’s Department of Otolaryngology and co-author on the study, both sit on OncoNano’s advisory board.
In January 2023, OncoNano announced that pegsitacianine had received Breakthrough Therapy Designation for Real-Time Surgical Imaging from the US Food and Drug Administration (FDA), which will fast-track the technology for development and regulatory review.
In a Phase II clinical trial published in the Annals of Surgical Oncology, the researchers tested the technology as part of cytoreductive surgery in patients with peritoneal metastases. However, a November 2023 UTSW press release noted that the technology is “tumor-agnostic and could potentially be used in other forms of cancer.” It is currently ready for Phase 3 trials, according to the OncoNano website.
More research and studies are needed to better understand this dynamic of cancer cells. Collectively, this research into cancer by different scientific teams is adding new insights into the way tumors originate and spread. At this time, these insights are not expected to lead to any new diagnostics tests that pathologists and clinical laboratories could use to detect cancer.
With FDA clearance already approved, hospital infection control teams and their clinical laboratories may have another diagnostic tool for diagnosing blood infections
Controlling sepsis in hospitals continues to be a major concern in nations around the world, including in the United States. Now, a new 10-minute clinical laboratory blood test that uses artificial intelligence (AI) and digital images to spot biomarkers of the potentially fatal condition may soon be available for use in hospitals. The test, which was approved to be marketed in the US in 2022 by the federal Food and Drug Administration (FDA), may be “one of the most important breakthroughs in modern medical history,” according to US researchers, Good News Network (GNN) reported.
“Early detection of sepsis is an invaluable capability for healthcare professionals. Quickly identifying sepsis is critical to saving lives, but until now, we’ve lacked a reliable tool to either recognize the condition or explore alternate diagnoses,” said O’Neal in an LSU press release.
“IntelliSep is truly a game changer,” said Hollis O’Neal, MD (above), Associate Professor of Medicine at Louisiana State University Health Sciences Center in Baton Rouge. “The test provides hospital staff with information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients.” Clinical laboratories may have a new blood test for sepsis by the end of the year. (Photo copyright: Louisiana State University.)
How IntelliSep Works
The IntelliSep test analyzes blood samples extracted from emergency room patients who present with sepsis symptoms by squeezing white blood cells through a tiny tube to determine how the cells react and if they change shape. White blood cells in patients with sepsis are softer and spongier and their shape compresses and elongates, increasing the likelihood of developing sepsis.
Images are taken of the cells using an ultra-high-speed camera that can capture up to 500,000 frames per second. The images are the analyzed by an AI-powered computer which calculates the total number of elongated white blood cells to determine if sepsis is present.
IntelliSep then separates patients into three bands of risk for developing sepsis:
Band 1 (low)
Band 2 (medium)
Band 3 (high)
Results of the test are available to emergency room personnel in less than 10 minutes.
“Sepsis is notorious as the ‘silent killer’ because it is so easily missed early on, when a patient’s symptoms can often be mistaken for other less serious illnesses,” Michael Atar, PhD, DDS, Associate Professor, Pediatric Dentistry at New York University told Good News Network. “Rapid diagnosis and treatment is crucial to a good outcome, but there has never been a single, reliable diagnostic test available to doctors, costing precious time and people’s lives.”
Atar is a lead medical technology investor and an advisor to Cytovale.
‘Holy Grail’ of Sepsis Diagnosis
To complete the IntelliSep study, researchers enrolled 1,002 ER patients who presented with signs of sepsis. IntelliSep correctly identified patients who did not have sepsis with an accuracy rate of 97.5%. The technology showed an accuracy rate of 55% for positive sepsis results. Researchers also used IntelliSep to quickly diagnose and assess the severity of a sepsis infection.
There were no sepsis deaths reported in patients with low-risk scores. This indicates the test could help physicians rule out sepsis and seek other diagnoses for those patients.
“Cytovale’s IntelliSep device is, by any objective measure, the ‘holy grail’ that the medical community has been so desperate to find,” Atar told Good News Network. “The technology behind it is genuinely groundbreaking and it has the real-world, tried-and-tested potential to save millions of lives, year on year, across the planet.”
The technology is currently being used in a few hospitals in Louisiana and the inventors hope to have it available in at least 10 other hospitals by the end of the year.
Our Lady of the Lake Regional Medical Center, a not-for-profit Catholic healthcare ministry located in Baton Rouge, was one of the first hospitals to implement IntelliSep.
“Cytovale’s innovative technology will help drastically decrease the number of sepsis-related deaths in hospital settings, and we are honored that, since day one, we have been a part of the research that led to this technology,” said Chuck Spicer, President of Our Lady of the Lake Health in a news release.
Saint Francis Medical Center in Monroe, La., announced on September 3 that it has started using the IntelliSep test in its emergency rooms and staff are impressed by the impact on hospital efficiency.
“If it turns out negative then you don’t have to treat as many patients as you did before, which runs up costs, hospital bills and causes people to be in the hospital for longer periods of time,” said pulmonary disease physician Thomas Gullatt, MD, President, St. Francis Health, told KNOE News.
Patient Expectations for Treatment
Sepsis, also known as septicemia or blood poisoning, is a serious medical condition that occurs when the body improperly reacts to an infection or injury. The dangerous reaction causes extensive inflammation throughout the body and, if not treated early, can lead to organ failure, tissue damage, and even death.
The Centers for Disease Control and Prevention (CDC) reports at least 1.7 million adults develop sepsis annually in the US and at least 350,000 die as a result of the condition. It also states sepsis is one of the main reasons people are readmitted to hospitals.
Clinical laboratories should be aware of developments in the use of this new diagnostic assay and how it is aiding the diagnosis, antibiotic selection, and monitoring of patients with this deadly infection. Patients often learn about new technologies and come to their hospital or provider expecting to be treated with these innovations.
