Microbiologists and clinical laboratory professionals should play a key role in the ordering and use of microbiome testing
International experts in the field of microbiome testing recently published a consensus document that establishes guidelines for the use and distribution of microbiota diagnostics they claim are long overdue. Companies offering direct-to-consumer (DTC) microbiome test kits continue to increase in number and popularity. But some experts in the human microbiome field—including microbiologists and clinical laboratory professionals—remain apprehensive regarding the science behind this type of home testing.
A Gemelli University news release states, “The intestinal microbiota could perhaps one day become a routine tool for the early diagnosis of many diseases and treatment guidance, but at the moment there is a lack of solid scientific evidence to support these indications. Yet, day by day, the offers of commercial kits are multiplying to carry out do-it-yourself tests, at the moment completely devoid of scientific significance and solidity.”
It continues, “To put a stop to this drift, a panel of international experts, coordinated by Dr. Gianluca Ianiro, has drafted the ‘instructions for use’ for best practices related to microbiota testing and recommendations for its indications, analysis methods, presentation of results and potential clinical applications.”
“This document marks a decisive step towards a standardization that has become indispensable making the microbiota an increasingly integrated element in personalized medicine,” said gastroenterologist Antonio Gasbarrini, MD (above), dean of the faculty of medicine and surgery and full professor of internal medicine at Catholic University of the Sacred Heart. “In the clinical context, these guidelines will be essential to translate research progress into concrete applications, improving the management of many gastroenterological and systemic diseases related to the microbiota,” he added. Microbiologists and clinical laboratory managers may want to follow efforts to promote these guidelines, both within healthcare and as they relate to consumers ordering their own microbiome tests. (Photo copyright: Agostino Gemelli University.)
Our Second Brain
The gut microbiome consists of the microorganisms that reside in the human gut and the small and large intestines. This ecosystem plays a major role in an individual’s health as it aids in digestion and metabolism. It also helps control inflammation and can strengthen the immune system.
“[The gut microbiome] contains all the microbes that reside within our intestinal tract. And those microbes are comprised of bacteria, fungi, yeast and viruses,” said Gail Cresci, PhD, RD, Director, Nutrition Research Center for Human Nutrition at the Cleveland Clinic in a Health Essentials article.
“What we’ve learned over the years is that there’s a lot of crosstalk between your gut microbiome and your body,” she added.
A healthy gut microbiome is imperative for good human health. An unhealthy gut microbiome can lead to certain diseases and even have a negative effect on mental health and mood.
“Your gut health is so important because studies really do indicate that our gut health plays a huge role in our overall health,” stated Kristin Kirkpatrick, MS, RDN, a dietician at the Cleveland Clinic Department of Wellness and Preventative Medicine, in the article. “It impacts our risk of chronic conditions, our ability to manage our weight, even our immune system. … There is so much attention and research on the microbiome and gut health now that experts often refer to it as the ‘second brain.’”
Future of Microbiome Testing
In their consensus document, the scientists wrote, “We convened an international multidisciplinary expert panel to standardize best practices of microbiome testing for clinical implementation, including recommendations on general principles and minimum requirements for their provision, indications, pre-testing protocols, method of analyses, reporting of results, and potential clinical value. We also evaluated current knowledge gaps and future directions in this field.”
The team’s intent is to provide guidelines and define quality standards and accuracy for microbiome testing to ensure consumers are receiving factual information.
“In recent years, the intestinal microbiota has taken on a key role as a diagnostic, prognostic and therapeutic tool,” said gastroenterology surgeon Serena Porcari, MD, of Gemelli University Hospital in Italy, in the Gemelli news release. “From this point of view, the first step, for a targeted modulation of the microbiota itself, is to obtain a standardization of its analysis, regulated according to the definition of minimum criteria for performing the test.”
The team also evaluated disparities between various tests and anticipated what lies ahead for the future of microbiome testing. In addition, they assessed ways to minimize inappropriate testing and established a framework for the development of evidence-based testing and the use of human microbiota diagnostics in clinical medicine.
“This consensus document represents a crucial step towards bringing order to the current panorama of diagnostic tests on the intestinal microbiota,” said Maurizio Sanguinetti, MD, director of the department of laboratory and hematological sciences at Gemelli Polyclinic Foundation, in the news release. “The diagnostic characterization of the intestinal microbiota must be based on rigorous standards, in order to guarantee reliable and clinically useful results. It is not a simple laboratory test, but a complex tool that requires a deep understanding of microbial dynamics and their impact on human health.
“This is why these analyses must be conducted by highly qualified personnel with specific expertise in clinical microbiology and bioinformatics,” he emphasized. “In our microbiology laboratory at the Fondazione Policlinico Gemelli, we already apply diagnostic tests on the intestinal microbiota following the principles and best practices outlined in the document.
“It is essential to invest in the training of future physicians and microbiologists so that they acquire the necessary skills to correctly interpret the results of these tests and apply them effectively in clinical practice. This document provides a valuable basis to guide not only the current use of the tests, but also their future development, always with a view to evidence-based and personalized medicine,” Sanguinetti concluded.
With popularity of microbiome testing on the rise, it’s important that microbiologists and clinical laboratory professionals stay informed on the latest developments in the field of microbiome diagnostics to protect healthcare consumers and their patients.
What researchers call “the largest proteomic study in the world” could lead to new clinical laboratory assays for determining genetic risk for multiple cancers
Examining blood proteins may be superior to clinical information in determining an individual’s risk for developing multiple diseases. That’s according to a new study conducted by researchers from the UK, America, and Germany who determined that measuring thousands of proteins from a single drop of blood can predict the onset of several illnesses.
The findings may provide clinical laboratories and physicians with new assays to more accurately predict an individual’s risk for more than 60 diseases.
“With data on genetic, imaging, lifestyle factors and health outcomes over many years, this will be the largest proteomic study in the world to be shared as a global scientific resource,” said Naomi Allen, MSc, DPhil, chief scientist at UK Biobank and professor of epidemiology, University of Oxford, in a UK Biobank news release. “These combined data could enable researchers to make novel scientific discoveries about how circulating proteins influence our health, and to better understand the link between genetics and human disease.”
“Measuring protein levels in the blood is crucial to understanding the link between genetic factors and the development of common life-threatening diseases,” said Naomi Allen, MSc, DPhil (above), chief scientist at UK Biobank and professor of epidemiology, University of Oxford, in a news release. With further study, this research could lead to new clinical laboratory assays that help physicians predict an individual’s risk for certain diseases including many forms of cancer. (Photo copyright: UK Biobank.)
Protein Signatures Outperform PSA Testing
To conduct their research, the team collected data from the UK Biobank Pharma Proteomics Project (UKB-PPP). This initiative is “one of the world’s largest studies of blood protein concentrations” and “aims to significantly enhance the field of ‘proteomics,’ enabling better understanding of disease processes and supporting innovative drug development,” according to the Biobank’s website.
The scientists analyzed the values of approximately 3,000 plasma proteins among 41,931 participants in the UKB-PPP. They examined the 10-year potential of developing certain diseases by measuring the plasma proteome and linking those observations to incident cases noted in electronic health records (EHRs).
The team specifically looked at the pathology types for several illnesses and utilized advanced techniques to identify a signature of proteins associated with those various diseases. They found their protein-based model exceeded traditional prediction methods when comparing the models with polygenic risk scores.
“We are therefore extremely excited about the opportunities that our protein signatures may have for earlier detection and ultimately improved prognosis for many diseases, including severe conditions such as Multiple myeloma and idiopathic pulmonary fibrosis,” she added. “We identified so many promising examples; the next step is to select high priority diseases and evaluate their proteomic prediction in a clinical setting.”
Identifying Individuals at High Risk for Certain Diseases
Of the thousands of known proteins in humans, the team focused on about 20 proteins found in blood. With as few as five proteins and as many as 20, they were able to do a risk assessment on 67 diseases, including:
The model could prove to be beneficial in the development of new therapies for certain diseases.
“A key challenge in drug development is the identification of patients most likely to benefit from new medicines. This work demonstrates the promise in the use of large-scale proteomic technologies to identify individuals at high risk across a wide range of diseases, and aligns with our approach to use tech to deepen our understanding of human biology and disease,” said Robert Scott, vice president and head of human genetics and genomics, GSK, and co-lead author of the study in the UCL news release.
“Further work will extend these insights and improve our understanding of how they are best applied to support improved success rates and increased efficiency in drug discovery and development,” he added.
“We are extremely excited about the opportunity to identify new markers for screening and diagnosis from the thousands of proteins circulating and now measurable in human blood,” said Claudia Langenberg, PhD, director of the Precision Healthcare University Research Institute (PHURI) at Queen Mary University of London and professor of computational medicine at the Berlin Institute of Health, in the UCL news release. “What we urgently need are proteomic studies of different populations to validate our findings, and effective tests that can measure disease relevant proteins according to clinical standards with affordable methods.”
More research and studies are needed before the protein-based model can be used to predict disease in clinical settings. However, the model could someday provide clinical laboratories, pathologists, and physicians with new assays that more accurately forecast an individual’s risk for certain illnesses.
Bacteria could become new biomarker for testing patients’ reaction to cancer treatments which would give microbiologists and clinical laboratories a new tool for aiding diagnosis and in the selection of appropriate therapies
In a surprising study conducted at King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, British scientists have discovered that a common bacteria found in the mouth may be able to “melt” certain cancers. The bacteria could also be used as a clinical laboratory biomarker to determine how patients may react to specific cancer treatments.
The researchers found that the presence of Fusobacterium can help neutralize head and neck cancers and provide better outcomes in patients with those diseases, according to a Kings College London news release.
“In essence, we found that when you find these bacteria within head and neck cancers, [patients] have much better outcomes,” said Miguel Reis Ferreira, MD, PhD, clinical oncologist at Guy’s and St Thomas’, adjunct senior clinical lecturer at King’s College London and senior author of the study, in the news release. “The other thing that we found is that in cell cultures this bacterium is capable of killing cancer.”
“This research reveals that these bacteria play a more complex role than previously known in their relationship with cancer—that they essentially melt head and neck cancer cells,” said Miguel Reis Ferreira, MD, PhD (above), clinical oncologist at Guy’s and St Thomas’, adjunct senior clinical lecturer at King’s College London and senior author of the study, in a news release. “However, this finding should be balanced by their known role in making cancers such as those in the bowel get worse.” Should these findings prove sound, clinical laboratories may soon have a new biomarker for testing patients’ reaction to cancer treatments. (Photo copyright: King’s College London.)
Researchers Surprised by Their Findings
The researchers began their research by using computer modeling to identify the types of bacteria to further scrutinize. They then studied the effect of those bacteria on cancer cells by analyzing data on 155 head and neck cancer patients whose tumor information had been submitted to the Cancer Genome Atlas. Head and neck cancers include cancers of the mouth, throat, voice box, nose, and sinuses.
The scientists placed Fusobacterium in petri dishes and kept the bacteria there for a few days. They observed the effect of that bacteria on head and neck cancers and discovered there was a 70% to 90% reduction in the number of viable cancer cells after being infused with the Fusobacterium.
Due to the known correlation between Fusobacterium and colorectal cancer, the team was astonished to find the cancer cells present in head and neck cancers had almost been eradicated.
In the news release, Ferreira said the researchers initially expected the Fusobacterium to boost the growth of the cancers and render those cancers more resistant to treatments like radiotherapy. However, they found the opposite to be true.
“The research in colorectal cancer indicates that these bacteria are bad, and that was kind of ingrained into our minds, and we were expecting to find the same thing,” said Ferreira in a Press Association (PA) interview, The Independent reported. “When we started finding things the other way around, we were brutally surprised.”
Predicting Better Outcomes, Lower Risk of Death
“You put it in the cancer at very low quantities and it just starts killing it very quickly,” Ferreira said in the King’s College London news release. “What we’re finding is that this little bug is causing a better outcome based on something that it’s doing inside the cancer. So we are looking for that mechanism at present, and it should be the theme for a new paper in the very short-term future.”
In addition, the scientists discovered that patients with Fusobacterium within their cancer showed improved survival rates when compared to those without the bacteria. The presence of the bacteria correlated with a 65% reduction in death risk.
“What it could mean is that we can use these bacteria to better predict which patients are more likely to have good or worse outcomes, and based on that, we could change their treatment to make it kinder in the patients that have better outcomes or make it more intense in patients that are more likely to have their cancers come back,” said Ferreira in the PA interview.
“Our findings are remarkable and very surprising. We had a eureka moment when we found that our international colleagues also found data that validated the discovery,” said Anjali Chander, PhD student, senior clinical research fellow, Comprehensive Cancer Center, King’s College London, and lead author of the study in the news release.
More to Learn about Bacteria as Biomarkers
According to the National Cancer Institute (NCI), more than 71,000 people will be diagnosed with one of the major types of head and neck cancer this year in the US and more than 16,000 patients will die from these diseases.
The Global Cancer Observatory (GLOBOCAN) estimates there are about 900,000 new cases of head and neck cancers diagnosed annually worldwide with approximately 450,000 deaths attributed to those cancers every year. GLOBOCAN also claims head and neck cancers are the seventh most common cancer globally.
More research and studies are needed to confirm the virtue of this latest venture into the human microbiome. However, the preliminary results of this study appear promising.
The study of human microbiota continues to bring unexpected surprises, as scientists gain more insights and identify specific strains of bacteria that may have a positive or negative influence on an individual’s health. These discoveries may give microbiologists and clinical laboratories intriguing new biomarkers that could be incorporated into medical tests that aid diagnosis and the selection of appropriate therapies.
Clinical laboratories will need new methods for accommodating the increase in senior patients seeking rapid access to medical laboratory testing and pathology services
Experts within the healthcare industry are predicting existing care delivery models will need to be revised within the next few years to accommodate a rapidly aging population dubbed a “silver tsunami.” Many hospital systems are actively taking steps to prepare for this coming sharp increase in the number of senior citizens needing healthcare services, including clinical laboratory testing.
Multi-hospital health systems will have to accommodate demand for healthcare delivered in ways that meet the changing expectations of seniors. These include rapid access to clinical laboratory testing and anatomic pathology services, electronic health records, and telehealth visits with their doctors.
These trends will also require clinical laboratories to evolve in ways consistent with meeting both the volume of services/testing and improved levels of personal, speedy access to test results that seniors expect.
All of this is problematic given the current state of hospital staff shortages across the nation.
Investopedia defines the term “silver tsunami” as “the demographic shift caused by the increasing number of older adults in society, led by the baby boom generation.”
Baby boomers are individuals who were born between 1946 and 1964. The US Census Bureau estimates there are 76.4 million baby boomers living in the country today, and that by 2030 all boomers will be 65 years of age or older.
“In the next five years, the most significant disruptor to healthcare will be the capacity challenges associated with the ‘silver tsunami’ of baby boomers hitting the age of healthcare consumption,” said Jonathan Washko, MBA, FACPE, NRP, AEMD (above), director at large, National Association of Emergency Medical Technicians (NAEMT) and assistant vice president, CEMS Operations, in an interview with Becker’s Hospital Review. Clinical laboratories will have to engage with these senior patients in new ways that fit their lifestyles. (Photo copyright: EMS1.)
Silver Tsunami Could Transform Healthcare
Approximately 10,000 people turn 65 in the US every day, making them eligible for Medicare. This increase in recipients is likely to strain the government system. Healthcare organizations are seeking new ways to prepare for the anticipated boost in seniors requiring health services.
Washko believes the population shift will cause healthcare leaders to develop novel care models based on “intelligent and intentional design for better outcomes, lower costs, and faster results,” Becker’s Hospital Review reported.
“Solutions will require shifts to care in the home, new operational care models, and technology integration,” Washko noted. “These will allow the medicine being delivered to be effectively and efficiently optimized, vastly improving the productivity of existing and net new capacity.”
A recent HealthStream blog post outlined some of the methods hospitals can use to adapt to an aging population. They include:
Facility Design: Modifying lighting, using large-print signage, providing reading glasses and hearing amplifiers, purchasing taller chairs with arms and lower examination tables.
Technology: Offering assistive devices, creating more telehealth options, developing more user-friendly websites and electronic medical records.
Healthcare Delivery: Training staff on geriatric care, offering services intended for an older population, such as geriatric psychology, fall prevention programs, and establishing a more patient-centered environment.
“Anticipated regulatory challenges post-election will influence healthcare operations. The looming recession may alter how individuals access healthcare and treatment based on affordability,” Shelly Schorer, CFO CommonSpirit Health, told Becker’s Hospital Review. “Despite these headwinds and challenges, at CommonSpirit we are prepared to pivot and meet the changing needs of our communities by accurately predicting and addressing their healthcare needs efficiently.”
“This represents the greatest market disruption on the near-horizon,” said Ryan Nicholas, MD, Chief Quality Officer at Mercy Medical Group. “This has prompted Mercy Medical Group to move rapidly into value-based care with focus on total cost of care and network integrity.”
Nichols told Becker’s Hospital Review that Mercy’s Medicare population has increased by 24% over the last year, and that Mercy is anticipating a growth of 28% over the next year. These increases have convinced the organization to shift its view of service functions and to invest in additional resources that meet the growing demands for senior healthcare.
“Expanding ambulatory services and improving access for primary care services to reduce unnecessary [emergency department] utilization and shorten length of stay is our top priority,” Nichols said.
Shifting Demand for Clinical Laboratory Testing
This is not the first time Dark Daily has covered how shifting demographics are changing the landscape of healthcare services in nations where populations are aging faster than babies are being born.
Thus, many healthcare organizations are taking a proactive approach to the expected increase in seniors needing care for age-related and chronic illnesses.
“This along with other risk and value-based models will continue to drive integration of healthcare services and the value proposition through improving quality while reducing costs,” Alon Weizer, MD, chief medical officer and senior vice president, Mount Sinai Medical Center, Miami Beach, Fla., told Becker’s Hospital Review. “While we are investing heavily to be successful in these models through primary care expansion and technology that will help reduce the need for acute care services, we continue to focus our culture on providing safe and high quality care to our patients.”
Clinical laboratories will need to adapt to the changing needs of older patients to ensure all people receive high quality care. The coming “silver tsunami” will require labs to evolve in ways consistent with meeting the growing needs of seniors and providing better levels of personal services and access to cost-effective, fast, and accurate lab testing.
Study findings could lead to new clinical laboratory screening tests that determine risk for cancer
New disease biomarkers generally lead to new clinical laboratory tests. Such may be the case in an investigational study conducted at the University of Oxford in the United Kingdom (UK). Researchers in the university’s Cancer Epidemiology Unit (CEU) have discovered certain proteins that appear to indicate the presence of cancer years before the disease is diagnosed.
The Oxford scientists “investigated associations between 1,463 plasma proteins and 19 cancers, using observational and genetic approaches in participants of the UK Biobank. They found 618 protein-cancer associations and 317 cancer biomarkers, which included 107 cases detected over seven years before the diagnosis of cancer,” News Medical reported.
To conduct their study, the scientists turned to “new multiplex proteomics techniques” that “allow for simultaneous assessment of proteins at a high-scale, especially those that remain unexplored in the cancer risk context,” News Medical added.
Many of these proteins were in “blood samples of people who developed cancer more than seven years before they received a diagnosis,” an Oxford Population Health news release notes.
“To be able to prevent cancer, we need to understand the factors driving the earliest stages of its development. These studies are important because they provide many new clues about the causes and biology of multiple cancers, including insights into what’s happening years before a cancer is diagnosed,” said Ruth Travis, BA, MSc, DPhil, senior molecular epidemiologist at Oxford Population Health and senior study author, in the news release.
“We now have technology that can look at thousands of proteins across thousands of cancer cases, identifying which proteins have a role in the development of specific cancers and which may have effects that are common to multiple cancer types,” said Ruth Travis, BA, MSc, DPhil (above), senior molecular epidemiologist, Oxford Population Health, in a news release. The study findings could lead to new clinical laboratory screening tests for cancer. (Photo copyright: University of Oxford.)
Proteomics to Address Multiple Cancers Analysis
In their published paper, the Oxford scientists acknowledged other research that identified links between blood proteins and risk for various cancers, including breast, colorectal, and prostate cancers. They saw an opportunity to use multiplex proteomics methods for the simultaneous measurement of proteins “many of which have not previously been assessed for their associations with risk across multiple cancer sites,” the researchers noted.
The researchers described “an integrated multi-omics approach” and the use of the Olink Proximity Extension Assay (PEA) to quantify 1,463 proteins in blood samples from 44,645 participants in the UK Biobank, a large biomedical database and resource to scientists.
Olink, a part of Thermo Fisher Scientific in Waltham, Mass., explains on its website that PEA technology “uniquely combines specificity and scalability to enable high-throughput, multiplex protein biomarker analysis.”
The researchers also compared proteins of people “who did and did not go on to be diagnosed with cancer” to determine differences and identify proteins that suggest cancer risk, News Medical reported.
Proteins Could Assist in Cancer Prevention
“To save more lives from cancer, we need to better understand what happens at the earliest stages of the disease. Data from thousands of people with cancer has revealed really exciting insights into how the proteins in our blood can affect our risk of cancer. Now we need to study these proteins in depth to see which ones could be reliably used for cancer prevention,” Keren Papier, PhD, senior nutritional epidemiologist at Oxford Population Health and joint lead author of the study, told News Medical.
While further studies and regulatory clearance are needed before the Oxford researchers’ approach to identifying cancer in its early stages can be used in patient care, their study highlights scientists’ growing interest in finding biomarker combinations that can predict or diagnose cancer even when it is presymptomatic. By focusing on proteins rather than DNA and RNA, researchers are turning to a source of information other than human genes.
For anatomic pathologists and clinical laboratory leaders, the Oxford study demonstrates how scientific teams are rapidly developing new knowledge about human biology and proteins that are likely to benefit patient care and diagnostics.
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 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.”
“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.
“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 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 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.
