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Blockchain Continues to Present Opportunities for Independent Hospital and Clinical Laboratories, as Aetna and Ascension Join Synaptic Health Alliance

Feb 18, 2019 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

These new additions to the Synaptic Health Alliance demonstrate an increasing belief among insurers that blockchain will improve the accuracy and exchange of critical healthcare data

Is blockchain technology ready for widespread use within healthcare? New developments show a growing interest among major health insurers to incorporate blockchain technology into their ongoing operations. As this happens, clinical laboratories will need a strategy, since a large proportion of all health data is made up of medical laboratory test results.

Dark Daily previously reported on how blockchain technology—with its big data and systemwide integration to existing healthcare provider directories—could alter how clinical laboratories obtain/store testing information and bill/receive payment for services rendered. We also covered how blockchain could enable insurers to instantly verify beneficiary’s coverage and attain interoperability between disparate electronic healthcare record (EHR) systems, including laboratory EHRs.

Now, insurers Aetna and Ascension have joined founding members UnitedHealthcare, Multiplan, Quest Diagnostics, Optum, and Humana in the Synaptic Health Alliance (SHA). These organizations formed SHA last year to “leverage [blockchain] technology to facilitate reaching across industry and competitive lines, creating a provider data exchange—a cooperatively owned, synchronized distributed ledger to collect and share changes to provider data,” according to the organization’s website.

What should be on the minds of every hospital and independent medical laboratory administrator is what will be required to engage in information exchange with such a distributed, non-centralized provider ledger.

What is Blockchain and How Does it Apply to Healthcare and Diagnostic Providers?

The SHA defines blockchain as “a shared, distributed digital ledger on which transactions are chronologically recorded in a cooperative and tamper-free manner [such as a] spreadsheet that gets duplicated multiple times across a network of computers, which is designed to regularly update the spreadsheet.”

Though the SHA’s efforts are still being tested, medical laboratories and pathology groups should note how Quest’s “physical relationship” with healthcare providers—as Jason O’Meara, Senior Director of Architecture at Quest Diagnostics describes it—gives the blood company an advantage. “The first day a practice opens up, they need internet, a telephone provider, and they have to have a diagnostics provider,” he told FierceHealthcare.

“Each of our organizations expends a tremendous amount of energy and effort trying to get this data as good as it can be,” O’Meara continued. “The challenge is—when we’re doing this in independent silos—it leads to duplication of efforts.”

O’Meara notes that while health plans collect needed information for months after a new practice opens, Quest often knows of these new locations “several weeks in advance” because new locations need supplies and the capability to order diagnostic tests from day one.

This physical-relationship advantage applies to all clinical laboratories, because they often are the first to know—and provide supplies to—new provider offices.

This informative video describes three ways blockchain will change healthcare. Click here to view the video or click on the image above. (Photo/video copyright: The Medical Futurist.)

Trimming Costs through Redundancy Elimination

Federal regulations require healthcare providers and payers to maintain frequently updated directories of care providers and services. These directories are then used across and between health networks to determine service availability, coverage options, and other critical elements related to obtaining care and reimbursements.

The Council for Affordable Quality Healthcare (CAQH) estimates the cost to maintain such directories is as high as $2.1 billion annually. Yet, even with that level of spending, a January 2018 Centers for Medicare and Medicaid Services (CMS) audit found that 52% of Medicare Advantage Organization (MAO) provider directories contained at least one error, FierceHealthcare reported.

The errors include providers who:

  • “Weren’t at the location listed;
  • “Didn’t accept the plan at that location;
  • “Who weren’t accepting new patients despite the directory saying that they were; and,
  • “Incorrect or disconnected phone numbers.”

In other words, CMS found that in its own MAO directories, about half of the information enrollees need to make important healthcare choices is either incorrect or out of date!

The SHA intends to change that by using blockchain to create a shared, up-to-the-minute accurate resource with interoperability between all participating providers.

By allowing alliance participants to consolidate directory updates, the system could eliminate silos and drastically reduce time and money spent applying updates to directories individually at each provider.

“We want this to be a public utility that every health plan and provider can participate on,” O’Meara told FierceHealthcare. “There’s no other technology we’re aware of that would allow for that type of robustness.”

Other Efforts to use Blockchain in Healthcare

In January, HealthPayerIntelligence (HPI) outlined another strategic initiative similar to the SHA involving Aetna, Anthem, Health Care Service Corporation (HCSC), IBM, and PNC Bank to create a “health utility network” using blockchain technology “to improve data accuracy for providers, regulators, and other stakeholders, and give our members more control over their own data.”

Lori Steele, Global Managing Director for IBM Healthcare and Life Sciences, told HPI that“blockchain’s unique attributes make it suitable for large networks of members to quickly exchange sensitive data in a permissioned, controlled, and transparent way.”

She continued, “The fact that these major healthcare players have come together to collaborate indicates the value they see in working together to explore new models that we think could drive more efficiency in the healthcare system and ultimately improve the patient experience.”

As medical laboratories continue to endure the financial pressures of healthcare reform, blockchain appears to offer yet another way to increase efficiencies, improve accuracy and accountability, and exchange data between disparate information systems.

While many possible uses for this technology remain in proof-of-concept and pilot-testing phases, pathologists and medical laboratory administrators looking to stay ahead of trends will want to keep up with blockchain as it continues to mature.

—Jon Stone

Related Information:

Aetna, Ascension Join Blockchain Alliance Targeting Provider Directories

Blockchain Collaborations in Health Care Continue to Grow

CMS: Errors Continue to Plague Medicare Advantage Plans’ Provider Directories

The Synaptic Health Alliance: A Look at How Blockchain Technology Could Improve Provider Data Quality

Humana, UnitedHealthcare Launch Blockchain Pilot Focused on Provider Directories

New Blockchain Collaboration Launches with Aetna, Anthem and HCSC

Aetna, IBM Launching New Blockchain Healthcare Network

Aetna, Anthem, HCSC Back Healthcare Blockchain Initiative

Aetna and Ascension Join Synaptic Health Alliance Blockchain Pilot for Healthcare Provider Data

Improving Provider Data Accuracy: A Collaborative Approach Using a Permissioned Blockchain

Blockchain Technology Could Impact How Clinical Laboratories and Pathology Groups Exchange Lab Test Data

McKinsey and Company Report Highlights Precision Medicine’s Advancements in Integrating Genetic Testing Results with Electronic Medical Records

Dec 31, 2018 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations

New McKinsey report offers three market trends that could help clinical laboratories position themselves as front-runners in the race toward precision medicine 

With federal Medicare reporting and reimbursement programs now weighted heavily toward precision medicine practices that involve genetic testing to reveal predispositions to certain diseases, the trend is widely recognized as the future of U.S. healthcare. But are clinical laboratories and anatomic pathology groups prepared to take advantage of the accelerating reporting and reimbursement requirements that go with it?

A report from global management consulting firm McKinsey and Company provides insights into how integrating genetic test results data into electronic medical records (EMRs) will impact the future of precision medicine (AKA, personalized medicine).

The report, titled, “Genetic Testing: Opportunities to Unlock Value in Precision Medicine,” notes, “Advanced analysis of genomic data integrated with electronic medical records and other data sets, combined with effective reimbursement strategies and full data-regulatory compliance, will distinguish winning diagnostics companies.”

Data/Costs Impact Profitability/Payments to Providers, including Medical Labs

The McKinsey report lists “three major trends that will affect the market for genetic testing.” They include:

  • “Data integration and analytics to realize the value of data have become increasingly important for the healthcare delivery value chain;
  • “Payers are facing increasing pressure on costs and looking for new opportunities to control them; and,
  • “The US reimbursement landscape, which drives the profitability of most diagnostics players, is gradually evolving.”

These market trends may provide a roadmap for labs working to position their business in a healthcare industry where genetic sequencing, the data it produces, and evolving reimbursement methods affect a clinical laboratories financial well-being.

The Value of Genetic Test Data

Personal health data derived from genetic sequencing has value at the individual patient’s level when linked with other health indicators, as recent deals between direct-to-consumer (DTC) genetics testing companies—such as 23andMe—and various pharmaceutical companies demonstrate.

And, as artificial intelligence continues to be integrated into medical diagnostic technology, such data becomes even more valuable.

“Genetic testing, along with the current blooming of “omics” technologies, will continue to drive the pace of precision medicine. In this golden age of bioinformatics, the reimbursement landscape is evolving. The winners will gain first-mover advantages by seamlessly integrating existing big genetic or molecular data with electronic medical records—in full accordance with data privacy laws—to validate tests clinically and analytically through real-time advanced analytics,” the McKinsey report predicts. (Image copyright: MTB Europe.)

There is strong movement toward integrating genetic information into electronic medical records, as the National Institutes of Health (NIH) eMERGE program clearly demonstrates.

The Electronic Medical Records and Genomics (eMERGE) Network brings together researchers from genomics, statistics, clinical settings, and other areas of expertise in order to “develop, disseminate, and apply approaches to research that combine biorepositories with electronic medical record systems,” according to NIH’s website.

Similar efforts are underway through the National Human Genome Research Institute’s IGNITE (Implementing Genomics in Practice) program and the PREDICT (Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment) program, launched in 2010 by Vanderbilt University.

However, data-privacy laws also are becoming stricter. HIPAA (Health Insurance Portability and Accountability Act) and GDPR (General Data Protection Regulation) strictly regulate the collection, retention, and sharing of patient data. Medical laboratories working to derive value from such data should ensure their processes are well within the letter of those laws.

Controlling the Impact of Cost and the Expense of Genetic Testing

In every area of healthcare, there are increasing pressures related to cost and genetic sequencing is no exception. McKinsey offers two reasons that payers are feeling the pinch:

  • Costs are growing faster than insurance premiums; and,
  • There are more innovative genetic and genome sequencing tests.

Payers hope that “innovative” genetic tests can lead to therapies or even cures that lower the cost of healthcare. However, a plethora of factors influence the development of genetic sequencing technology. Nevertheless, consumer demand is driving the costs down.

DTC genetic testing companies are leveraging these lowered costs. However, they also have other revenue streams—marketing their customers’ data, for example.

Although it may seem that 23andMe’s business model derives most of its revenue from selling its genotyping kits, that’s just one of the company’s revenue streams. In 2015, biotechnology company Genentech and DTC genetic testing company 23andMe reached a $60 million deal that gave Genentech access to test results data derived from 23andme customers who had previously signed agreements allowing their data to be used for research.

Dark Daily recently reported on one DTC genetic test customer who attempted to get her test results removed entirely from the Internet. (See, “Erasing ‘DNA Footprint’ from the Internet Proves Difficult for Consumers Who Provide Data to Genetic Testing Companies,” December 24, 2018.)

Opportunities for Clinical Labs

The three market trends included in the McKinsey report provide some guidance for clinical laboratories and genetic testing companies strategizing to be on the cusp of precision medicine.

Medical laboratories that integrate their data with physicians’ practice EHRs will be rewarded with first-mover status as genetic testing continues to evolve and become more recognized as a critical clinical tool. Additionally, clinical laboratories will play a key role in helping physicians prove medical necessity for genetic tests.

—Dava Stewart

 

Related Information:

Genetic Testing: Opportunities to Unlock Value in Precision Medicine

Electronic Medical Records and Genomics (eMERGE) Network

Implementing Genomics in Practice (IGNITE)

Personalized Drug Prescribing Program Expands, Upgrades

Trends in Microbiology

From Theory to Practice: Translating Whole-Genome Sequencing (WGS) into the Clinic

Erasing ‘DNA Footprint’ from the Internet Proves Difficult for Consumers Who Provide Data to Genetic Testing Companies

Singapore University Researchers Unveil Portable $1 Point-of-Care Testing That Speedily Tests for Multiple Diseases

Dec 28, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

Hand-held tests developed from the work of the NUS BIGHEART team could help caregivers in remote areas diagnose disease quickly, accurately, and inexpensively

There is great demand in Asia for diagnostic tests that are cheap, accurate, and have a fast time to answer. Especially in Asia’s remote and mobile clinics where caregivers need immediate access to clinical laboratory test results at the time of patients’ visits.

Researchers at the National University of Singapore (NUS) have unveiled just such a test that could eventually be performed at the point-of-care using smartphones for disease detection and analysis.

Dark Daily has reported many times on new clinical laboratory tests that use smartphones in past e-briefings. They are among the most significant developments to impact the pathology industry in our times.

According to the NUS researchers, their test can screen, detect, and analyze multiple diseases through a nucleic acid test platform. Best of all, the test costs less than $1, operates at room temperature, and takes about 30 minutes to an hour to uncover diseases.

NUS published the study in Nature Communications.

Researchers Aim to Simplify Complex Lab Testing

“Rapid, visual detection of pathogen nucleic acids has broad applications in infection management,” the researchers wrote in their study. They found that a screening device using molecular agents to detect disease-specific molecules has implications for a range of diseases: from Zika and Ebola to hepatitis, dengue, malaria, and cancers, according to a news release.

The NUS researchers dubbed their creation enVision (enzyme-assisted nanocomplexes for visual identification of nucleic acids).

2018-0918-enVision-graphic

The enVision microfluidic system (above) consists of a series of enzyme–DNA nanostructures to enable target recognition, target-independent signaling, and visual detection. The common cartridge houses the universal signaling nanostructures, which are immobilized on embedded membranes, for target-independent signaling and visual detection. The platform is designed to complement the modular enVision workflow. (Image and caption copyright: National University of Singapore.)

“Conventional technologies—such as tests that rely on polymerase chain reaction to amplify and detect specific DNA molecules—require bulky and expensive equipment, as well as trained personnel to operate these machines. With enVision, we are essentially bringing the clinical laboratory to the patient,” said Nicholas Ho, PhD, an NUS Biomedical Institute for Global Health Research and Technology (BIGHEART) Research Fellow and study co-first author, in the news release.

Shao-Lab-NUS-BIGHEART-enVision

NUS BIGHEART researchers include Assistant Professor Huilin Shao, PhD, at center holding the enVision cartridge, with Nicholas Ho, PhD, to the left and Lim Geok Soon, PhD, to the right. They tested the performance of enVision on human papillomavirus (HPV), a sexually transmitted infection and primary cause of cervical cancer. HPV has more than 100 subtypes of which 15 are malignant. The researchers studied samples from 35 NUS patients. (Photo copyright: National University of Singapore.)

“HPV is a global epidemic. While mostly benign, some of these infections can progress to cause deadly cervical cancer,” they wrote in Nature Communications. “Point-of-care testing that can distinguish the infection subtypes, and be performed at the patient level, could bring tremendous opportunities for patient stratification and accessible monitoring and is associated with better health outcomes.”

NUS researchers found that the enVision platform had a 95% accuracy rate in screening for HPV, as compared to conventional lab testing, according to Singapore’s Straits Times.

“While laboratory tests can detect one to two HPV strains, the kit is able to detect over 10 strains and has better coverage for each strain,” said Assistant Professor Huilin Shao, PhD, NUS BIGHEART, in the Straits Time article.

How Does it Work? 

The test’s steps, according to an NUS News article, include:

  • The tiny plastic chip holds the sample (blood, urine, or saliva) for analysis, along with a DNA “molecular machine” to recognize genetic sequences;
  • This sample is channeled to a common signal cartridge containing another DNA molecular machine;
  • Visual signals are evidence of disease-specific molecules and an assay turns from colorless to brown if disease is present;
  • Further analysis, potentially using a smartphone app, could delve into the extent of an infection.

“The first machine is a recognition nanostructure which detects specific genetic sequences that relate to different kinds of diseases—the pathogens, bacteria, or viruses for example—and produces a signal,” Ho told NUS News. “It pairs up with what we call an amplifier nanostructure which takes that signal, amplifies it and turns it into a color read-out.”

The researchers note that more studies on other diseases are needed before marketing of the test kit, which they developed over 18 months. The NUS team also sees opportunities to enable better image capabilities and analysis algorithms through smartphone applications (apps).

“Large cohort studies on the detection of pathogen nucleic acids across a spectrum of diseases (e.g., other infections, cancers, inflammatory disorders) using various biological specimens (e.g., tissue, blood, urine) could be performed to validate the clinical utility of the enVision technology for diverse visual detection,” they concluded in Nature Communications.

As healthcare resources become limited and populations continue to grow, studies into portable, low-cost testing become more critical. Clinical laboratories performing tests in rural, outlying areas of the world will especially benefit from the work of researchers like the NUS BIGHEART team at University of Singapore.

—Donna Marie Pocius

Related Information:

New Test Kit Invented by NUS Researchers Enables Quick, Accurate, and Inexpensive Screening of Diseases

Cheap Portable Screening Kit for Multiple Diseases in the Works

Visual and Modular Detection of Pathogen Nucleic Acids with Enzyme-DNA Molecular Complexes

72 Cents Test Screens for Diseases in Less Than an Hour

enVisioning Future Disease Diagnostics

New Fast Inexpensive Mobile Device Accurately Identifies Healthcare-acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers

Multi-channel Smartphone Spectrometer Enables Clinical Laboratory Testing Quickly and Accurately in Remote Regions

Researchers at New York Genome Center and Columbia University Discover Why Certain Genetic Mutations Cause Disease in Some Individuals and Not in Others

Dec 26, 2018 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations

Determining the reason why people with similar genetic makeups can have different risk levels for disease could help scientists develop more accurate tools that clinical laboratories and pathology groups can use for diagnosis and prognosis

It’s been a big question for genetic scientists that now may have part of an answer. Why do individuals who carry identical gene mutations for a particular disease often experience different disease symptoms and severity? The question relates to variable penetrance and a new study suggests some reasons why this is often true.

Researchers at the New York Genome Center (NYGC) and the Columbia University Department of Systems Biology performed the study by examining the important implications of a genetic irregularity known as variable penetrance in human disease.

The researchers published their findings in the scientific journal Nature Genetics.

Disease Risk Determined by Combination of Coding and Regulatory Gene Variants

The phenomenon of variable penetrance refers to the severity of the effects of disease-causing variants and how they may differ among individuals who carry those genetic variants. Variable penetrance has proven to be a challenge when predicting the severity of a disease even when a strong genetic association is present.

The researchers developed a hypothesis for modified penetrance, where genetic variants that regulate gene activity can alter the disease risk caused by protein-coding gene variants. The study links modified penetrance to specific diseases at the genome level, which could help predict the severity of some diseases.

“Our findings suggest that a person’s disease risk is potentially determined by a combination of their regulatory and coding variants, and not just one or the other,” stated Tuuli Lappalainen, PhD, Group Leader at the New York Genome Center and Assistant Professor at Columbia University, in a news release. “Most previous studies have focused on either looking for coding variants or regulatory variants that affect disease in these individuals or potentially looking at common variants that could affect disease. We have merged these two fields into one clear hypothesis that uses data from both of them, which was fairly unheard of before.”

NYGC-Columbia-University-Tuuli-Lappalainen-PhD-Stephane-Castel-PhD

Tuuli Lappalainen, PhD (top photo left), and Stephane Castel, PhD (bottom photo left), of the New York Genome Center (NYGC) and Columbia University, co-led the new study. The hypothesis of the study is illustrated here with an example in which an individual is heterozygous for both a regulatory variant and a pathogenic coding variant. The two possible haplotype configurations would result in either decreased penetrance of the coding variant, if it was on the lower-expressed haplotype, or increased penetrance of the coding variant, if it was on the higher-expressed haplotype. (Image and caption copyrights: NYGC.)

The researchers first tested their modified penetrance hypothesis by analyzing data from the Genotype-Tissue Expression (GTEx) Project, a database created by the National Institutes of Health (NIH) to increase our understanding of how genes contribute to diseases. By evaluating the interactions of regulatory and coding variants in people without severe genetic disorders, they found an enrichment of haplotypes, a group of alleles of different genes on a single chromosome that are closely enough linked to be inherited.

Haplotypes protect against disease by decreasing the penetrance of coding variants associated with disease development. Because the researchers were looking at individuals without severe genetic diseases, the presence of enhanced haplotypes was expected.

The scientists then tested their hypothesis of modified penetrance in a disease-specific population of patients. They analyzed data from The Cancer Genome Atlas (TCGA), a database complied by the NIH, along with information from the Simons Simplex Collection (SSC).

The SSC is a project of the Simons Foundation Autism Research Initiative (SFARI) that has a permanent repository of genetic samples from 2,600 families, each of which has one child affected with autism spectrum disorder (ASD), and unaffected parents and siblings.

In both the cancer patients and individuals with ASD, the researchers discovered an enrichment of haplotypes forecasted to increase the penetrance of coding variants associated with the two disorders.

The team then designed an experiment using CRISPR/Cas9 genome editing technology to test their modified penetrance hypothesis. For this portion of the experiment, they chose a coding variant associated with Birt-Hogg-Dube´ Syndrome, a rare genetic disorder that can cause susceptibility to certain types of tumors.

By editing the single-nucleotide polymorphism (SNP) into a cell line on different haplotypes with a regulatory variant, they were able to prove that the regulatory variant did modify the effect of the coding disease-causing variant.

“Now that we have demonstrated a mechanism for modified penetrance, the long-term goal of the research is better prediction of whether an individual is going to have a disease using their genetic data by integrating the regulatory and coding variants,” said Lappalainen in the news release.

New Tools for More Precise Diagnosis/Prognosis

This discovery should help provide a framework for scientists to test disease SNPs to assess if they could be affected by modified penetrance, which could help medical professionals better predict an individual’s potential risk of disease development and severity.

“In the future, studies of the genetic causes of severe diseases should take into account this idea that regulatory variants need to be considered alongside coding variants,” said Stephane Castel, PhD, Senior Research Fellow at NYGC, in the news release. “This should eventually lead to a more fine-grained understanding of the risk of coding variants associated with disease.”

Of course, such test are years away from clinical use. However, the NYGC/Columbia University study highlights how much more precise diagnosis/prognosis could become with these types of tools.

Should further research validate these early insights, clinical laboratories could soon have new genetic tests that better predict and identify which health outcomes patients should expect based on their unique genetic makeup.

—JP Schlingman

Related Information:

Research: Molecular Mechanism Explains Why Genetic Mutations Affect Some People

Modified Penetrance of Coding Variants by Cis-regulatory Variation Contributes to Disease Risk

New Study Explains Why Genetic Mutations Cause Disease in Some People but Not in Others

Dr. Tuuli Lappalainen Awarded Major NIH Grant to Study Genomic Phenomenon Variable Penetrance

Duke University Study Suggests the Human Body Starves Gut Bacteria to Produce Beneficial Results

Dec 19, 2018 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, News From Dark Daily

Human microbiota is linked to many diseases but could hold the key for advanced clinical laboratory tests and targeted precision medicine therapies

Study of the human microbiome continues to provide understanding and knowledge regarding gut bacteria and its many benefits, and incites development into new clinical laboratory tests. However, a new study reveals that our bodies might also put gut bacteria under stress leading to better health.

Traditionally, scientists believe the human gut is a hospitable environment that allows bacteria to thrive. However, microbiologists may be interested in a study by Duke University School of Medicine (Duke) that suggests the relationship between humans and their microbiomes may be adversarial as well.

In fact, the study found that human hosts are starving their microbes of nutrients and forcing them to compete for food for the benefit of the host.

“There appears to be a natural pecking order to the bacteria and us,” noted Lawrence A. David, PhD, Assistant Professor, Department of Molecular Genetics and Microbiology at Duke University School of Medicine, in an article Duke posted on Phys.org. “In a way it’s not surprising that we, the host, should hold more of the cards.”

Duke researchers published the results of their study in Nature Microbiology, an online peer-reviewed scientific journal.

Could Nitrogen Impact Gut Bacteria?

The human microbiome consists of hundreds of different types of bacteria and other various tiny organisms, such as viruses and fungi. When combined, the microbes in the human gut weigh approximately three pounds or about the same as the brain.

The theory behind Duke’s study was that the human microbiome is an ecosystem comprised of various entities that compete for resources, and which are often constricted by nutrients, such as nitrogen or phosphorus.

To perform the study, Aspen Reese, PhD, a PhD candidate at Duke during the study and now a Junior Fellow researcher at Harvard University, procured stool samples from more than 30 types of mammals. She then ground the individual samples and tabulated the number of nitrogen and carbon atoms contained within those samples.

 

The animals used for the study included wild zebras, giraffes and elephants from Kenya, domestic sheep, cattle and horses from New Jersey, and humans from North Carolina. The graphic above shows how “carbon-to-nitrogen ratios in poop vary between animals as a result of diet and physiology. These ratios also govern the abundance of microbes in their guts.” (Image copyright: Aspen Reese/Harvard University.)

Reese discovered that the bacteria in the human gut had access to only one nitrogen atom for every 10 carbon atoms. The bacteria in other mammals’ guts had access to one nitrogen atom for every four carbon atoms. The question arose: Could nitrogen levels in the human gut impact the microbiome?

Reese performed tests on mice to determine if nitrogen levels could help regulate the microbiome. She fed the mice a diet packed with protein, which naturally contains a large amount of nitrogen. When she increased the amount of protein fed to the mice, the amount of their gut bacteria also increased. Reese then injected nitrogen directly into the bloodstream of the mice and found that some of that nitrogen ended up in their gut bacteria.

This discovery suggests the host can help save microbes in the gut by secreting nitrogen through the cells.

“Our findings support the idea that we’ve evolved a way to keep our bacteria on a leash by leaving them starving for nitrogen,” David noted on Phys.org. “It also explains why the Western diet might be bad for us. When people eat too much protein, it swamps the host’s ability to take up that nitrogen in the small intestine, and more of it ends up making its way to the large intestine, eliminating our ability to control our microbial communities.” (Photo copyright: Duke University School of Medicine.)

Antibiotics and Gut Bacteria

The team also performed a previous study regarding the effects of antibiotics on gut bacteria, which they published in June on eLife, an online open-access journal.

In that study, the researchers gave mice a five-day treatment of antibiotics. By analyzing their stool samples daily, the scientists discovered that many of the energy sources needed by microbes in the gut accumulated as bacteria was depleted. Some species of valuable gut bacteria are eliminated by antibiotics and may never return.

The researchers found that the mice had to eat each other’s stools in order for those essential microbes to return.

“People probably won’t want to do that,” David told Phys.org.

The trillions of microbes that reside in the human gut help manage almost every function of the human body. Poor gut health can contribute to a wide variety of health problems, including allergies, arthritis, dementia, diabetes, cardiovascular disease, leaky gut syndrome, and some cancers and autoimmune diseases.

Factors such as diet, sleep habits, stress levels, and the number of bacteria an individual is exposed to on a regular basis can negatively affect the microbiome.

Continuing research into the mysteries contained in the human microbiome provide valuable data about our gut bacteria. This type of information could eventually help microbiologists and clinical laboratory professionals more accurately identify diseases and health conditions and guide physicians to appropriate, and possibly targeted, precision medicine therapies for patients.

—JP Schlingman

 

Related Information:

Our Microbes Are Starving, and That’s a Good Thing

Scientists Reveal How Gut Microbes ‘Recover’ after Antibiotic Treatment

How and Why Our Bodies Starve Gut Bacteria

Loss of Microbial Gut Diversity a Threat to Health?

Microbial Nitrogen Limitation in the Mammalian Large Intestine

How Many Cells Are in the Human Body—And How Many Microbes?

Mayo Clinic Researchers Find Some Bacteria Derail Weight Loss, Suggest Analysis of Individuals’ Microbiomes; a Clinical Lab Test Could Help Millions Fight Obesity

University of Illinois Study Concludes Regular Physical Exercise Improves Human Microbiome; Might Be Useful Component of New Treatment Regimens for Cancer and Other Chronic Diseases

Researchers in Two Separate Studies Discover Gut Microbiome Can Affect Efficacy of Certain Cancer Drugs; Will Findings Lead to a New Clinical Laboratory Test?

Why It’s Time for All Clinical Laboratories and Anatomic Pathology Groups to have a Genetic Testing and Gene Sequencing Strategy

Dec 3, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

As personalized medicine becomes more popular, clinical laboratories, and anatomic pathologists are uniquely positioned to use next-generation sequencing to advance their scope among regulators, insurers, providers and patients, while adding clinical value and generating a new revenue source

By now, most clinical pathologists and medical laboratory scientists recognize that genetics, genetic testing, and gene sequencing will be a major transformative force in this country’s healthcare system. Genetics is the future of modern medicine.

At the same time, most independent labs and health network labs still lack the key resources needed for them to provide accurate and state-of-the-art genetic testing and gene sequencing services in support of clinical care.

The good news is that it is not yet prime time for genetic testing—meaning few genetic tests have become part of routine care, particularly in primary care settings. Today’s limited use of genetic tests creates the opportunity for any medical laboratory and anatomic pathology group to use this time to develop its genetic testing strategy. It also has time to incrementally put in place the resources it will need to offer genetic testing and gene sequencing services to its client physicians.

“Every clinical lab that wants to be a provider of genetic tests needs three basic resources,” stated Robert L. Michel, Editor-in-Chief of The Dark Report and Dark Daily. “First, the lab must have information technology in place that can handle genetic and molecular data. The second thing needed are pathologists, PhDs, and clinical laboratory scientists trained in genetic and molecular diagnostics. Of course, the third resource is to have the lab analyzers, instruments, and automation needed to extract, amplify, and sequence specimens.”

Experts agree that adoption of genetic testing will happen at a rapid pace. “Next-generation sequencing (NGS) is an incredibly powerful, positive force in medical care. We were in the Dark Ages before this. It is the tsunami on our shores, and it’s going to take over all of medicine. It’s not a trend. It’s the future of medicine. There’s no question about it,” predicts Maurie Markman, MD, an oncologist and President of Medicine and Science at Cancer Treatment Centers of America, in an article he penned for Health Connect South.

 

“As knowledge of genomic medicine has increased, its cost has plummeted,” notes Maurie Markman, MD (above), President of the Cancer Treatment Centers of America, in his Health Connect South article. “Sequencing a human genome [in 2015] costs less than $10,000, compared to more than $100 million in 2001. Not only are the tests more available to patients, but more oncologists are trying their hand at tumor testing and building on the base of knowledge.” (Photo copyright: Cancer Treatment Centers of America.)

“If you agree with Markman’s comments, then your medical lab should have a plan for how it will incorporate NGS technologies and genetic testing into its menu of lab tests,” observed Michel. “Because NGS is the engine powering much of this new genetic information and igniting the potential of personalized medicine, probably the single most important business step clinical labs and pathology groups can take at this point is to begin to create the informatics capabilities needed to support genetic testing.

“This can be done by either adding the needed functions to the existing laboratory information system (LIS) or supplementing that LIS with appropriate middleware solutions,” he continued. “This is true even if a lab plans to outsource both the gene sequencing and the annotation and interpretation of the resulting gene sequences. It will need in-house informatics capabilities to store and report that genetic information.”

NGS, Gene Sequencing, Precision Medicine, and Clinical Laboratories

Purchasing, implementing, and operating NGS technologies can be a costly venture, so it is critical that labs know and understand the needs of their referring clients.

“Knowing who your lab’s customers are and what you do for them today should guide you as a laboratory,” notes Brian Keefe, Vice President of Sales and Customer Innovation at Psyche Systems, a laboratory solutions developer for the medical industry based in Boston. “For example, your pathology group knows it should be offering NGS testing, and the justification for needing to go in this direction is because 90% of your clients are oncologists.”

Using NGS technology and marketing it to clients will be a valuable benefit for clinical laboratories. It will enable labs to participate in personalized medicine and allow them to become the “go to” facility for specific genetic tests.

“If you’re a laboratory that has figured out how to map the genome for nightmare bacteria, it doesn’t matter whether you’re three miles or 3,000 miles away, physicians will send their samples to your lab regardless of the distance,” Keefe notes. “If your lab is first to market, you establish powerful brand recognition and attract positive attention, which justifies your lab’s cost to set up and offer that testing in the first place.”

Learn More by Requesting the Dark Daily NGS White Paper

To help medical laboratories and anatomic pathology groups learn more about the growing role of NGS in clinical care, and how NGS can benefit clinical and molecular laboratories, Dark Daily and The Dark Report have produced a white paper titled, “How Next-Generation Sequencing Helps Molecular Laboratories Deliver Personalized Medicine Services to their Client Physicians.”

Medical laboratory leaders who want to learn how labs can establish NGS services and implement the IT/Informatics needed to be successful in using NGS should request a copy of this important white paper. It reviews how pathologists can help providers select targeted therapies and touches on marketing strategies to use NGS to procure new customers and retain existing customers.

The NGS white paper can be downloaded at no cost by clicking here or placing https://www.darkdaily.com/how-next-generation-sequencing-helps-molecular-laboratories-deliver-personalized-medicine-services-to-their-client-physicians-601/ into your browser.

—JP Schlingman

Related Information:

How Next-Generation Sequencing Helps Molecular Laboratories Deliver Personalized Medicine Services to their Client Physicians

Genomic Medicine: The Future of Cancer Treatment Is Now

Clinical Pathology Labs Are on Track to Get New Genetic Test That Screens for 448 Rare Childhood Diseases

Is Whole-genome Sequencing Reaching a Tipping Point for Clinical Pathology Laboratories?

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