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International Researchers Draft Consensus Document That Establishes Framework for Microbiome Testing

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.

In their paper, the team, led by microbiota researchers Antonio Gasbarrini, MD, Giovanni Cammarota, MD, and Gianluca Ianiro, MD, professors at the Agostino Gemelli University Polyclinic Foundation IRCCS and Catholic University of the Sacred Heart, wrote, “We aimed to establish a framework to regulate the provision of microbiome testing and minimize the use of inappropriate tests and pave the way for the evidence-based development and use of human microbiome diagnostics in clinical medicine.”

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.”

The experts published their paper, “International Consensus Statement on Microbiome Testing in Clinical Practice,” in the journal Lancet Gastroenterology and Hepatology.

“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.

—JP Schlingman

Related Information:

International Experts Set Framework for Microbiota Diagnostics

Gut Microbiota: A Consensus Document Brings Order to Diagnostic Testing

International Consensus Statement on Microbiome Testing in Clinical Practice

How Your Gut Microbiome Impacts Your Health

Mayo Clinic Scientists Develop AI Tool That Can Determine If Gut Microbiome is Healthy

Next-Generation Sequencing Allows Mayo Clinic Researchers to Produce Large Dataset of Patients’ Exomes

Nearly 100,000 patients submitted saliva samples to a genetic testing laboratory, providing insights into their disease risk

Researchers at Mayo Clinic have employed next-generation sequencing technology to produce a massive collection of exome data from more than 100,000 patients, offering a detailed look at genetic variants that predispose people to certain diseases. The study, known as Tapestry, was administered by doctors and scientists from the clinic’s Center for Individualized Medicine and produced the “largest-ever collection of exome data, which include genes that code for proteins—key to understanding health and disease,” according to a Mayo Clinic news release.

For our clinical laboratory professionals, this shows the keen interest that a substantial portion of the population has in using their personal genetic data to help physicians identify their risk for many diseases and types of cancer. This support by healthcare consumers is a sign that labs should be devoting attention and resources to providing these types of gene sequencing services.

As Mayo explained in the news release, the exome includes nearly 20,000 genes that code for proteins. The researchers used the dataset to analyze genes associated with higher risk of heart disease and stroke along with several types of cancer. They noted that the data, which is now available to other researchers, will likely provide insights into other diseases as well, the news release notes.

The Mayo Clinic scientists published their findings in Mayo Clinic Proceedings titled, “Mayo Clinic Tapestry Study: A Large-Scale Decentralized Whole Exome Sequencing Study for Clinical Practice, Research Discovery, and Genomic Education.”

“What we’ve accomplished with the Tapestry study is a blueprint for future endeavors in medical science,” said gastroenterologist and lead researcher Konstantinos Lazaridis, MD (above), in the news story. “It demonstrates that through innovation, determination and collaboration, we can deeply advance our understanding of DNA function and eventually other bio-molecules like RNA, proteins and metabolites, turning them into novel diagnostic tools to improve health, prevent illness, and even treat disease.” Some of these newly identified genetic markers may be incorporated into new clinical laboratory assays. (Photo copyright: Mayo Clinic.)

How Mayo Conducted the Tapestry Study

One notable aspect of the study was its methodology. The study launched in July 2020 during the COVID-19 pandemic. Since many patients were quarantined, researchers conducted the study remotely, without the need for the patients to visit a Mayo facility. It ran for five years through May 31, 2024. The news release notes that it’s the largest decentralized clinical trial ever conducted by the Mayo Clinic.

The researchers identified 1.3 million patients from the main Mayo Clinic campuses in Minnesota, Arizona, and Florida who met the following eligibility criteria:

  • Participants had to be 18 or older,
  • they had to have internet and email access, and
  • be sufficiently proficient in speaking and reading English.

Patients with certain medical conditions, such as dementia and hematologic cancers, were excluded.

More than 114,000 patients consented to participate, but some later withdrew, resulting in a final sample of 98,222 individuals. Approximately two-thirds were women. Mean age was 57 (61.9 for men and 54.3 for women).

“It was a tremendous effort,” said Mayo Clinic gastroenterologist and lead researcher Konstantinos Lazaridis, MD, in the news release. “The engagement of such a number of participants in a relatively short time and during a pandemic showcased the trust and the dedication not only of our team but also of our patients.”

He added that the researchers “learned valuable lessons about some patients’ decisions not to participate in Tapestry, which will be the focus of future publications.”

Three Specific Genes

Enrolled patients were invited to visit a website, where they could view a video and submit an eligibility form. Once approved, they completed a digital consent agreement and received a saliva collection kit. Participants were also invited to provide information about their family history.

Helix, a clinical laboratory company headquartered in San Mateo, Calif., performed the exome sequencing.

Though Helix performed whole exome sequencing, the researchers were most interested in three specific sets of genes:

Patients received clinical results directly from Helix along with information about their ancestry. Clinical results were also transmitted to Mayo Clinic for inclusion in patients’ electronic health records (EHRs).

Among the participants, approximately 1,800 (1.9%) had what the researchers described as “actionable pathogenic or likely pathogenic variants.” About half of these were BRCA1/2.

These patients were invited to speak with a genetic counselor and encouraged to undergo additional testing to confirm the variants.

Tapestry Genomic Registry

In addition to the impact on the participants, Mayo Clinic’s now has an enormous amount of raw sequencing data stored in the Tapestry Genomic Registry, where it will be available for future research.

The database “has become a valuable resource for Mayo’s scientific community, with 118 research requests submitted,” the researchers wrote in the news release. Mayo has distribution more than a million exome datasets to other genetic researchers.

“What we’ve accomplished with the Tapestry study is a blueprint for future endeavors in medical science,” Lazaridis noted. “It demonstrates that through innovation, determination, and collaboration, we can deeply advance our understanding of DNA function and eventually other bio-molecules like RNA, proteins and metabolites, turning them into novel diagnostic tools to improve health, prevent illness, and even treat disease.”

Everything about this project is consistent with precision medicine, and the number of individuals discovered to have risk of cancers is relevant. Clinical laboratory professionals understand these ratios and the importance of early detection and early intervention. 

—Stephen Beale

Related Information:

Mayo Clinic Tapestry Study: A Large-Scale Decentralized Whole Exome Sequencing Study for Clinical Practice, Research Discovery, and Genomic Education

Mayo Clinic’s Largest-Ever Exome Study Offers Blueprint for Biomedical Breakthroughs

Mayo Clinic to Study 10,000 Patients for Drug-Gene Safety

Hospital Bills Insured Woman $18k for Biopsy Procedure the Healthcare Provider’s Online Patient Payment Estimator Said Would Typically Cost Uninsured Patients $1,400

Though the No Surprises Act was enacted to prevent such surprise billing, key aspects of the legislation are apparently not being enforced

Dani Yuengling thought she had properly prepared herself for the financial impact of a breast biopsy. After all, it’s a simple procedure, especially if done by fine needle aspiration (FNA). Then, the 35-year-old received a bill for $18,000! And that was after insurance and though she had received a much lower advanced quote, according to an NPR/Kaiser Health News (NPR/KHN) bill-of-the-month investigation.

So, what happened? And what can anatomic pathology groups and clinical laboratories do to ensure their patients don’t receive similar surprise bills?

Yuengling had lost her mother to breast cancer in 2017. Then, she found a lump in her own breast. Following a mammogram she decided to move forward with the biopsy. Her doctor referred her to Grand Strand Medical Center in Myrtle Beach, S.C.

But she needed to know how much the procedure would cost. Her health plan had a $6,000 deductible. She worried she might have to pay for the entire amount of a very expensive procedure.

However, the hospital’s online “Patient Payment Estimator” informed her that an uninsured patient typically pays about $1,400 for the procedure. Yuengling was relieved. She assumed that with insurance the amount would be even less, and thankfully, clinical laboratory test results of the biopsy found that she did not have breast cancer.

Then came the sticker shock! The bill broke down like this:

  • $17,979 was the total for her biopsy and everything that came with it.
  • Her insurer, Cigna, brought the cost down to the in-network negotiated rate of $8,424.14.
  • Her insurance then paid $3,254.47.
  • Yuengling was responsible for $5,169.67 which was the balance of her deductible.

So, why was the amount Yuengling owed higher than the bill would have been if she had been uninsured and paid cash for the procedure?

According to the NPR/KHN investigation, this is not an uncommon occurrence. The investigators reported that nearly 30% of American workers have high deductible health plans (HDHPs) and may face larger expenses than what a hospital’s cash price would have been for uninsured individuals.

“We can very confidently say this is very common,” Ge Bai, PhD, CPA, professor of accounting at John Hopkins Carey Business School and professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, told NPR/KHN.

Dani Yuengling (above) knew she had to take the lump in her breast seriously. Her mother had died of breast cancer. “It was the hardest experience, seeing her suffer,” Yuengling told NPR/KHN. Fortunately, following a biopsy procedure, clinical laboratory testing showed she was cancer free. But the bill for the procedure was shockingly higher than she’d expected based on the hospital’s patient payment estimator. (Photo copyright: Kaiser Health News.)

Take the Cash Price

In 2021, Bai was part of a John’s Hopkins research team that analyzed US hospital cash prices compared with commercial negotiated rates for specific healthcare services.

The team published its findings in JAMA Network Open titled, “Comparison of US Hospital Cash Prices and Commercial Negotiated Prices for 70 Services.”

“The 70 CMS-specified hospital services represent 74 unique Current Procedural Terminology (CPT) diagnosis related group codes (four services were represented by two codes),” the authors wrote. “Cash prices and payer-specific negotiated prices for the 70 services were obtained from Turquoise Health, a data service company that specializes in collecting pricing information from hospitals.”

They continued, “Cash prices can affect the cost exposure of 26 million uninsured individuals and concern nearly one-third of US workers enrolled in high-deductible health plans, who are often responsible to pay for medical bills without a third-party contribution and thus are interested in having access to low cash prices. In contrast with the commercial price negotiated bilaterally between hospitals and insurers providing insurance plans, the cash price is determined unilaterally by the hospital and might be expected to be higher than negotiated prices.”

However, the team’s research found otherwise. “Across the 70 CMS-specified services … some hospitals set their cash price comparable to or lower than their commercial negotiated price,” they concluded.

Bai advises patients to ask healthcare providers about the cash price before undergoing any procedure no matter what their insurance status is. “It should be a norm,” she told NPR/KHN.

Federal No Surprises Act is not Foolproof

Yuengling was charged an extraordinarily high amount for her procedure compared to other hospitals in her area. Fair Health Consumer estimates the cost of the procedure Yuengling received cost an average of $3,500 at other local hospitals. Uninsured patients likely pay even less.

A spokesperson for Grand Street Medical Center blamed the inaccurate estimate on “a glitch” in the payment estimator system. The hospital has since removed some procedures from the tool until it can be corrected. Yuengling initially disputed the charge with the hospital but in the end decided to pay the full amount she owed.

NPR/KHN recommends that insured patients consult with their health insurance company to get an estimate before any procedure. That is the purpose of the No Surprises Act which was enacted as part of the Consolidated Appropriations Act, 2021 (CAA).

The law requires health insurance companies to provide their members with an estimate of medical costs upon their request. The Act also empowers patients to file federal complaints about their medical bills.

This, however, is not a foolproof plan and patients may still be facing unexpected costs. Sabrina Corlette, JD, research professor, founder, and co-director of the Center on Health Insurance Reforms (CHIR) at Georgetown University’s McCourt School of Public Policy, told NPR/KHN that the part of the law requiring health insurance companies to provide an “Advanced Explanation of Benefits” is not yet being enforced.

Patients who find themselves in a similar situation to Yuengling may want to consider paying the cash price for the procedure. Although this may not be common practice, Jacqueline Fox, JD, a healthcare attorney and professor of law at the University of South Carolina’s Joseph F. Rice School of Law, told NPR/KHN that there is not a law she is aware of that would prohibit patients from doing so.

Anatomic pathology groups and clinical laboratories should check that their online prices and estimation tools comply with the No Surprises Act to ensure that what happened to Yuengling does not happen with their patients. They also could inform patients on how to pay cash for procedures if insurance rates are too high. Medical professionals and patients can work together to achieve transparency in healthcare pricing.

—Ashley Croce

Related Information:

An $18,000 Biopsy? Paying Cash Might Have Been Cheaper than Using Her Insurance

Comparison of US Hospital Cash Prices and Commercial Negotiated Prices for 70 Services

Patient Rights Group Says Too Many Hospitals Are Not Complying with CMS Price Transparency Rules

Price Transparency: What Labs Need to Know Now about Existing Regulations and Pending Legislation

CMS Proposes New Amendments to Federal Hospital Price Transparency Rule That May Affect Clinical Laboratories and Pathology Groups

Uniformed Services University and Northwestern University Researchers Discover How a Hardy Microbe Resists Lethal Amounts of Ionizing Radiation

Pathology professor developed a synthetic compound based on the mighty microbe that could lead to new forms of protection from deadly radiation

Researchers at Uniformed Services University of the Health Sciences (USU) and Northwestern University (NWU) have discovered the secret behind the ability of Deinococcus radiodurans (D. radiodurans)—a microbe dubbed “Conan the Bacterium”—to withstand levels of ionizing radiation that would kill other organisms, according to an NWU news release. The discovery may lead to new forms of protection from radiation exposure and also have applications in vaccine development.

The research also could provide new opportunities for clinical laboratories to be involved in diagnosing patients’ conditions and help guide selection of appropriate radiation therapies.

The protection comes not from D. radiodurans itself, but from a synthetic antioxidant called melatonin-derived protective (MDP) developed by Michael Daly, PhD, a professor in USU School of Medicine’s Department of Pathology who was inspired by chemistry within the microbe, according to the news release.

“It is this ternary complex that is MDP’s superb shield against the effects of radiation,” said Brian Hoffman, PhD, in the press release. Hoffman, a professor of chemistry at NWU, worked with Daly on the research.

The secret, the two scientists discovered, lies in the combination of three components: phosphate and a designed synthetic peptide known as DP1 which are bound to manganese.

The researchers published their findings titled, “The Ternary Complex of Mn2+, Synthetic Decapeptide DP1 (DEHGTAVMLK), and Orthophosphate Is a Superb Antioxidant,” in the journal Proceedings of the National Academy of Sciences (PNAS).

“We’ve long known that manganese ions and phosphate together make a strong antioxidant, but discovering and understanding the ‘magic’ potency provided by the addition of the third component is a breakthrough,” said Brian Hoffman, PhD (above), Professor of Molecular Biosciences at Northwestern University. “This study has provided the key to understanding why this combination is such a powerful—and promising—radioprotectant.” Continuing research in this area might give clinical laboratories new opportunities to screen patients for vaccines and radiation treatments. (Photo copyright: Northwestern University.)

Surviving on Mars

The new research built on a 2022 study, also led by Daly and Hoffman, in which the scientists tried to determine how long D. radiodurans and other microorganisms could survive on Mars when dried and frozen. As noted in an earlier NWU press release, the planet “is constantly bombarded by intense galactic cosmic radiation and solar protons.”

They subjected the microbes to the same cold and arid conditions present on Mars and exposed the organisms to varying levels of radiation. The researchers determined that if deeply buried, D. radiodurans could survive for more than 280 million years and withstand 140,000 grays of radiation. “This dose is 28,000 times greater than what would kill a human,” the press release notes.

Using an advanced spectroscopy technique, the researchers measured the levels of manganese antioxidants within the microorganisms. They determined that higher amounts of the antioxidants increased resistance to radiation.

Fabricating MDP

Daly describes MDP as “a simple, cost-effective, nontoxic and highly effective radioprotector,” according to Live Science.

“Ionizing radiation—such as X-rays, gamma rays, solar protons and galactic cosmic radiation—is highly toxic to both bacteria and humans,” Daly, told Live Science, adding, “In bacteria, radiation can cause DNA damage, protein oxidation, and membrane disruption, leading to cell death. In humans, radiation exposure can result in acute radiation syndrome, increased cancer risk, and damage to tissues and organs.”

Manganese is part of a complex within the microbes that removes the free radicals, Live Science explained.

Daly’s team designed a “lab-made version” of this mechanism by combining manganese and phosphate ions with a synthetic peptide that is similar to amino acids within the microbe.

In the new study, the researchers used a technique known as advanced paramagnetic resonance spectroscopy to characterize MDP, revealing the ternary complex as the “active ingredient” that gives it protective powers.

Real-world Applications for MDP

Daly described some potential applications of their discovery.

“Astronauts on deep-space missions are exposed to chronic high-level ionizing radiation, primarily from cosmic rays and solar protons,” he told Live Science, suggesting that MDP “could be administered orally to mitigate these space radiation risks.”

He added that MDP could also be used as a form of prevention against acute radiation syndrome. “There’s also a well-recognized link between radiation resistance and aging,” he said.

The technology could also lead to new radiation-inactivated vaccines, the latest NWU press release notes.

A team of scientists at USU employed MDP to develop an experimental vaccine that could help prevent chlamydia infection, according to a USU press release. The technology enabled researchers to inactivate the bacterium with radiation while protecting the proteins needed to stimulate immune response.

“If you want an effective whole-cell chlamydia vaccine, then you should probably try not to cook, zap, or otherwise damage the surface antigens that it relies on,” said USU researcher and assistant professor in the department of microbiology and immunology George Liechti, PhD, in the press release.

In a study to gauge the vaccine’s potential, researchers vaccinated mice and then exposed them to the mouse pathogen Chlamydia muridarum, which is related to the human Chlamydia trachomatis.

The mice “showed faster infection clearance, lower bacterial levels, and less tissue damage compared to traditional vaccines,” the press release states.

This new understanding of how antioxidants work is opening avenues of research that could lead to vaccines for radiation exposure and treatments for radiation illnesses. Clinical laboratories will play a role in screening patients and helping pathologists determine the most effective treatments.

—Stephen Beale

Related Information:

How ‘Conan the Bacterium’ Withstands Extreme Radiation

The Ternary Complex of Mn2+, Synthetic Decapeptide DP1 (DEHGTAVMLK), and Orthophosphate Is a Superb Antioxidant

‘Conan the Bacterium’ Can Withstand Radiation That Could Kill a Human. Scientists Say They’ve Found Its Secret Weapon

‘Conan the Bacterium’ Can Survive Extreme Radiation, and Scientists Finally Know Why

Radiation-Resistant ‘Extremophile’ Microbe Dubbed ‘Conan the Bacterium’ Inspires New Antioxidant

USU Researchers Develop New Vaccine Candidate to Combat Chlamydia

British Researchers Discover Common Mouth Bacteria That ‘Melts’ Head and Neck Cancers

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.

Fusobacterium is a genus of anaerobic gram-negative bacteria that are prevalent colonizers of the mouth microbiome. It can be associated with mouth abscesses, periodontal disease, skin ulcers, and Lemierre’s syndrome. The most common species of the genus, Fusobacterium nucleatum, is a marker for the early prediction, diagnosis, and prognosis of colorectal cancer.

“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.”

The researchers published their findings in the journal Cancer Communications titled, “Fusobacterium is Toxic for Head and Neck Squamous Cell Carcinoma, and its Presence May Determine a Better Prognosis.”

“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.

—JP Schlingman

Related Information:

Type of Mouth Bacteria ‘Melts’ Some Cancers, Study Finds

Bacteria ‘Melts’ Head and Neck Cancer in Revolutionary Discovery

Fusobacterium is Toxic for Head and Neck Squamous Cell Carcinoma, and its Presence May Determine a Better Prognosis

Bacteria ‘Melts’ Head and Neck Cancer in Revolutionary Discovery

Common Mouth Bacteria Found to ‘Melt’ Certain Cancers in ‘Surprising’ Discovery

Fusobacterium Nucleatum, a Key Pathogenic Factor and Microbial Biomarker for Colorectal Cancer

Detection of Fusobacterium in Oral and Head and Neck Cancer Samples: A Systematic Review and Meta-analysis

Coming Wave of Retirees Predicted to Trigger ‘Silver Tsunami’ That Will Drive Changes in How Hospitals Deliver Care

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.

“In this environment, coupled with lowering revenues, staffing shortages and higher expenses, healthcare is being forced from an abundance mindset to one of scarcity,” Jonathan Washko, MBA, FACPE, NRP, AEMD, director at large, National Association of Emergency Medical Technicians (NAEMT) and assistant vice president, CEMS Operations, told Becker’s Hospital Review.

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. 

Government Healthcare Changes

There are also looming coverage changes for Medicare recipients as the federal Centers for Medicare and Medicaid Services (CMS) plans to transition from fee-for-service models to value-based models to lower government healthcare expenses.

“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.

In “Demographic Shift Means Lower Birthrates and Aging Populations around the World, Suggesting Big Changes for Global Healthcare, Pathology Groups, and Clinical Laboratories,” we reported how having fewer pediatric patients and more senior citizens is fundamentally altering what types of tests are in greatest demand from medical laboratories worldwide.

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.

—JP Schlingman

Related Information:

Health Systems Brace for the ‘Silver Tsunami’

Overcoming the ‘Silver Tsunami’

‘Silver Tsunami’: Challenges and Opportunities of an Aging Population

How Will the Silver Tsunami Affect Non-Acute Care?

Is Your Hospital Ready for the “Silver Tsunami”?

Silver Tsunami: Can Our Healthcare System Adapt to Aging Population and Mental Health Challenges?

Demographic Shift Means Lower Birthrates and Aging Populations Around the World, Suggesting Big Changes for Global Healthcare, Pathology Groups, and Clinical Laboratories

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