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Clinical Laboratories and Pathology Groups

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All of Us Genomic Research Program Hits Milestone of 250,000 Whole Genome Sequences

Expanded genomic dataset includes a wider racial diversity which may lead to improved diagnostics and clinical laboratory tests

Human genomic research has taken another important step forward. The National Institutes of Health’s All of Us research program has reached a milestone of 250,000 collected whole genome sequences. This accomplishment could escalate research and development of new diagnostics and therapeutic biomarkers for clinical laboratory tests and prescription drugs.

The wide-reaching program aimed at gathering diverse genomic data is giving scientists access to the nearly quarter million whole genome sequences—as well as genotyping arrays, long-read genome sequences, and more—to aid precision medicine studies, the National Institutes of Health (NIH) announced in a news release.

The NIH’s All of Us program “has significantly expanded its data to now include nearly a quarter million whole genome sequences for broad research use. About 45% of the data was donated by people who self-identify with a racial or ethnic group that has been historically underrepresented in medical research,” the news release noted.

Detailed information on this and future data releases is available at the NIH’s All of us Data Roadmap.

Andrea Ramirez, MD

“For years, the lack of diversity in genomic datasets has limited our understanding of human health,” said Andrea Ramirez, MD, Chief Data Officer, All of Us Research Program, in the news release. Clinical laboratories performing genetic testing may look forward to new biomarkers and diagnostics due to the NIH’s newly expanded gene sequencing data set. (Photo copyright: Vanderbilt University.)

Diverse Genomic Data is NIH’s Goal

NIH launched the All of Us genomic sequencing program in 2018. Its aim is to involve more than one million people from across the country and reflect national diversity in its database.

So far, the program has grown to include 413,450 individuals, with 45% of participants self-identifying “with a racial or ethnic group that has been historically under-represented in medical research,” NIH said.

“By engaging participants from diverse backgrounds and sharing a more complete picture of their lives—through genomic, lifestyle, clinical, and social environmental data—All of Us enables researchers to begin to better pinpoint the drivers of disease,” said Andrea Ramirez, MD, Chief Data Officer of the All of Us research program, in the news release.

More than 5,000 researchers are currently registered to use NIH’s All of Us genomic database. The vast resource contains the following data:

  • 245,350 whole genome sequences, which includes “variation at more than one billion locations, about one-third of the entire human genome.”
  • 1,000 long-read genome sequences to enable “a more complete understanding of the human genome.”
  • 413,350 survey responses.
  • 337,500 physical measurements.
  • 312,900 genotyping arrays.
  • 287,000 electronic health records.
  • 15,600 Fitbit records (data on sleep, activity, step count, heart rate).

The research could lead to:

  • Better understanding of genetic risk factors for disease.
  • Development of predictive markers for disease risk.
  • Analysis of drugs effectiveness in different patients.

Data Shared with Participants

Participants in the All of Us program, are also receiving personalized health data based on their genetic sequences, which Dark Daily previously covered.

In “US National Institutes of Health All-of-Us Research Program Delivering Genetic Test Results and Personalized Disease Risk Assessments to 155,000 Study Participants,” we reported how the NIH had “begun returning personalized health-related DNA results” to more than 155,000 study participants. In addition, participants who requested their results will receive genetic reports that detail whether they “have an increased risk for specific health conditions and how their body might process certain medications.”

“Through a partnership with participants, researchers, and diverse communities across the country, we are seeing incredible progress towards powering scientific discoveries that can lead to a healthier future for all of us,” said Josh Denny, MD, Chief Executive Officer, All of Us Research Program, in the news release.

Cloud-based Tool Aids Access to Data

The All of Us program makes a cloud-based platform—called Researcher Workbench—available to scientists for the study of genetic variation and other issues, Inside Precision Medicine explained.

“[Researchers] can get access to the tools and the data they need to conduct a project with our resources in as little as two hours once their institutional data use agreement is signed,” said Fornessa Randal, Executive Director, Center for Asian Health Equity, University of Chicago, in a YouTube video about Researcher Workbench.

A paper published in Annual Review of Biomedical Data Science titled, “The All of Us Data and Research Center: Creating a Secure, Scalable, and Sustainable Ecosystem for Biomedical Research,” noted that  the diseases most often being studied by researchers using All of Us data include:

Database’s Growth Good for Precise Diagnostics

For diagnostics professionals, the growth of available whole human genome sequences as well as access to participants in the All of Us program is noteworthy.

Also impressive is the better representation of diversity. Such information could result in medical laboratories having an expanded role in precision medicine.  

—Donna Marie Pocius

Related Information:

All of Us Research Program Makes Nearly 250,000 Whole Genome Sequences Available to Advance Precision Medicine

US National Institutes of Health All of Us Research Program Delivering Genetic Test Results and Personalized Disease Risk Assessments to 155,000 Study Participants

All of Us Research Hub

All of Us Researcher Workbench

All of Us Program Expands Whole Genome Data Available to Researchers

All of Us Releases Almost 250,000 Genomes

All of Us Data and Research Center Creating a Secure, Scalable, and Sustainable Ecosystem for Biomedical Research

Mapping Out the Human Genome

Survey Indicates Zoomers and Millennials Are Ready for Pharmacies to Play a Bigger Role in Their Primary Care

Demand for low cost, convenient access to doctors and drugs is driving transformation to decentralized medical care, and retail pharmacy chains see opportunity in offering primary care services

Retail pharmacies and pharmacists continue to play a growing role in healthcare as consumer demand for lower cost and convenience pushes the nation’s medical landscape away from centralized healthcare systems. Clinical laboratories have seen this in the increasing trend of consumers seeking vaccinations and home-health tests at their local drug stores.

Results of a pair of surveys dubbed “Pharmacy Next” conducted by Wolters Kluwer Health revealed that 58% of people are now willing to be treated for non-emergency healthcare conditions in non-traditional medical environments, such as retail pharmacies and clinics.

This is a finding that clinical laboratory managers and pathologists should incorporate into their labs’ strategic planning. It portends a shift in care away from the traditional primary care clinic—typically located in the campus around the community hospital—and toward retail pharmacies. Labs will want to capture the test referrals originating from the primary care clinics located in retail pharmacies.

This willingness to access medical care in non-traditional environments is especially true among people in Generation Y (Millennials) and Generation Z (Zoomers)—people born between 1981-1996 (Gen Y) and 1997-2012 (Gen Z), according to Journey Matters.

“As we saw in last year’s survey, primary care decentralization is continuing—the traditional one doctor-one patient, single point of coordination is vanishing, and this is especially evident in younger generations,” said Peter Bonis, MD, Wolters Kluwer’s Chief Medical Officer, in a press release

The online surveys of more than 2,000 US adults was weighted by age, gender, household income, and education to be representative of the entire population of the United States. 

“By preparing for this shift today, providers can work in concert across care sites to deliver the best care to patients,” said Peter Bonis, MD, Wolters Kluwer Health Chief Medical Officer, in a press release. “Likewise, newer care delivery models, like retail pharmacies and clinics, can ensure they’re ready to meet the expectations of healthcare consumers, who will increasingly be turning to them for a growing range of care needs.” Clinical laboratories may find new revenue opportunities working with the primary care clinics operating within local retail pharmacists and clinicians. (Photo copyright: Wolters Kluwer.)

Key Findings of the Wolters Kluwer Pharmacy Next Studies

Some key insights of the surveys include:

  • Care is rapidly decentralizing with 58% stating they are likely to visit a local pharmacy for non-emergency medical care.
  • Younger generations are signaling lasting change within the industry as they are more open to non-traditional styles of care.
  • 61% of respondents envision most primary care services being provided at pharmacies, retail clinics, or pharmacy clinics within the next five years. Of the respondents, 70% of Millennials, 66% of Gen Z, 65% of Gen X, and 43% of Baby Boomers believe this transition will occur.
  • Consumers are worried about prescription costs and availability.
  • 92% of respondents said physicians and pharmacists should inform patients of generic options.
  • 59% of surveyed consumers have concerns about drug tampering and theft when it involves mail order or subscription prescription services.
  • One in three respondents believe convenience is more important than credentials in non-emergency situations.

The survey indicates that healthcare consumers across multiple generations are open to a shift in some medical services from doctors to pharmacists. However, there were some notable differences between generations.

Respondents of the Baby Boomer (55%) and Gen X (57%) generations stated they would trust a physician assistant with medication prescriptions, while only 42% of Gen Z and 47% of Millennial respondents felt the same way. 

Additionally, Boomers (57%) and Gen X (67%) said they would feel comfortable with a nurse practitioner issuing their prescriptions, while only 44% of Gen Z and 53% of Millennials said they would. 

Increased Comfort with Genetic Testing at Pharmacies

The surveys also showed that younger generations are more open to the field of pharmacogenomics, which combines pharmacology and genomics to analyze how an individual’s genetic makeup (aka, heredity) affects the efficacy and reactions to certain drugs. This is a key component of precision medicine.

Overall, 68% of individuals polled believe their individual genomic data could guide prescription decisions, with Millennials (77%) and Gen Z (74%) being the primary believers. Additionally, 88% of respondents stated they see an incentive for health insurers to cover genomic testing, and 72% said they would be open to genetic testing for personalized medical care

But pharmacists and clinicians should be aware that advancing pharmacogenomics will require addressing privacy concerns. According to the Wolters Kluwer study, 57% of Gen Z and 53% of Millennials have apprehension surrounding genetic testing due to privacy risks, with 35% of Gen X and Boomers holding that same opinion.

Healthcare Staff Shortages, Drug Cost a Concern

Survey respondents are also concerned about pharmacy staff shortages and expenditures when seeking care at a pharmacy. Half of the participants are worried they will receive the wrong medication, half worry about getting the incorrect dosage, and almost half (47%) fear receiving the wrong directions due to overburdened pharmacy employees.

More people in Gen Z (59%) and Millennials (60%) had these concerns compared to Gen X (44%) and Boomers (38%).

Sadly, a distressing 44% of those surveyed admitted to not filling a prescription due to the costs. That number jumps to a staggering 56% among individuals with no health insurance, compared to 42% for insured patients.

“From hospitals to doctors’ offices, from pharmacies to pharma and beyond, healthcare must move to more affordable and accessible primary care models, adopt innovations that help deliver more personalized care, and address persistent safety and cost concerns that consumers have about their medications,” said Bonis in the press release.

Can Pharmacies Deliver Primary Care as Well as Doctor’s Offices?

Pharmacies may be logical setting for at least some non-emergency health services. According to the Centers for Disease Control and Prevention (CDC), approximately 90% of the US population live within five miles of a pharmacy and about 72% of visits to physician’s offices involve the prescribing and monitoring of medication therapies.

“Pharmacies did step up during the COVID-19 pandemic. The proof is there that pharmacies can do it,” noted Kevin Nicholson, JD, Vice President of Policy, Regulatory, and Legal Affairs for the National Association of Chain Drug Stores (NACDS), during this year’s Healthcare Information and Management Systems Society (HIMSS) in April,  HealthLeaders reported.

“We’re not talking about complicated services. We’re talking low-acuity, very basic care,” said Anita Patel, PharmD, Vice President of Pharmacy Services Development for Walgreens, at the HIMSS conference.

Pharmacies across the country continue to add more healthcare services to their available public offerings. This trend will likely persist into the future as healthcare becomes more expensive, wait times for physician appointments increases, and medical staff shortages rise. Thus, there may be opportunities for clinical laboratories to support pharmacists and doctors working in retail settings.

—JP Schlingman

Related Information:

What the Next Generation’s Expectations for Primary Care Mean for Pharmacists

US Survey Signals Big Shifts in Primary Care to Pharmacy and Clinic Settings as Consumers Seek Lower Medication and Healthcare Costs

Pharmacy Next: Safer, Affordable and Personalized

Pharmacy Next: Health Consumer Medication Trends

Pharmacy Next: Safety, Service, and Spending

Pharmacy Next: Consumer Trends and Industry Transformation

Wolters Kluwer’s Pharmacy Next Survey Shows 58% of Americans Likely to First Seek Non-emergency Healthcare at Pharmacies

The 7 Generations: What do we know about them?

Should a Pharmacist Be Allowed to Deliver Primary Care Services?

Community Pharmacists’ Contributions to Disease Management during the COVID-19 Pandemic

Executive War College Headliners Connect Genetic Testing, Wearable Technology, Precision Medicine, and Struggle Over Claim Reimbursement between Clinical Labs and Payers

Keynote speakers advise clinical laboratory leaders to leverage diagnostic data that feeds precision therapies

At this week’s Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans, keynote presenters dissected ways that clinical laboratory leaders and anatomic pathologists can contribute to innovative treatment approaches, including wearable technology and precision medicine.

The speakers also noted that labs must learn to work collaboratively with payers—perhaps through health information technology (HIT)—to establish best practices that improve reimbursements on claims for novel genetic tests.

Harnessing the ever-increasing volume of diagnostic data that genetic testing produces should be a high priority for labs, said William Morice II, MD, PhD, CEO and President of Mayo Clinic Laboratories.

“There will be an increased focus on getting information within the laboratory … for areas such as genomics and proteomics,” Morice told the keynote audience at the Executive War College on Wednesday.

William Morice II, MD, PhD

“Wearable technology data is analyzed using machine learning. Clinical laboratories must participate in analyzing that spectrum of diagnostics,” said William Morice II, MD, PhD (above), CEO and President of Mayo Clinic Laboratories. Morice spoke during this week’s Executive War College.

Precision Medicine Efforts Include Genetic Testing and Wearable Devices

For laboratories new to genetic testing that want to move it in-house, Morice outlined effective first steps to take, including the following:

  • Determine and then analyze the volume of genetic testing that a lab is sending out.
  • Research and evaluate genetic sequencing platforms that are on the market, with an eye towards affordable cloud-based options.
  • Build a business case to conduct genetic tests in-house that focuses on the long-term value to patients and how that could also improve revenue.

Morice suggested that neuroimmunology is a reasonable place to start with genetic testing. Mayo Clinic Laboratories found early success with tests in this area because autoimmune disorders are rising among patients.

A related area for clinical laboratories and pathology practices to explore is their role in how clinicians treat patients using wearable technology.

For example, according to Morice, Mayo Clinic has monitored 20,000 cardiac patients with wearable devices. The data from the wearable devices—which includes diagnostic information—is analyzed using machine learning, a subset of artificial intelligence.

In one study published in Scientific Reports, scientists from Mayo’s Departments of Neurology and Biomedical Engineering found “clear evidence that direct seizure forecasts are possible using wearable devices in the ambulatory setting for many patients with epilepsy.”

Clinical laboratories fit into this picture, Morice explained. For example, depending on what data it provides, a wearable device on a patient with worsening neurological symptoms could trigger a lab test for Alzheimer’s disease or other neurological disorders.

“This will change how labs think about access to care,” he noted.

For Payers, Navigating Genetic Testing Claims is Difficult

While there is promise in genetic testing and precision medicine, from an administrative viewpoint, these activities can be challenging for payers when it comes to verifying reimbursement claims.

“One of the biggest challenges we face is determining what test is being ordered. From the perspective of the reimbursement process, it’s not always clear,” said Cristi Radford, MS, CGC, Product Director at healthcare services provider Optum, a subsidiary of UnitedHealth Group, located in Eden Prairie, Minnesota. Radford also presented a keynote at this year’s Executive War College.

Approximately 400 Current Procedural Terminology (CPT) codes are in place to represent the estimated 175,000 genetic tests on the market, Radford noted. That creates a dilemma for labs and payers in assigning codes to novel genetic tests.

During her keynote address, Radford showed the audience of laboratory executives a slide that charted how four labs submitted claims for the same high-risk breast cancer panel. CPT code choices varied greatly.

“Does the payer have any idea which test was ordered? No,” she said. “It was a genetic panel, but the information doesn’t give us the specificity payers need.”

In such situations, payers resort to prior authorization to halt these types of claims on the front end so that more diagnostic information can be provided.

“Plans don’t like prior authorization, but it’s a necessary evil,” said Jason Bush, PhD, Executive Vice President of Product at Avalon Healthcare Solutions in Tampa, Florida. Bush co-presented with Radford.

[Editor’s note: Dark Daily offers a free webinar, “Learning from Payer Behavior to Increase Appeal Success,” that teaches labs how to better understand payer behavior. The webinar features recent trends in denials and appeals by payers that will help diagnostic organizations maximize their appeal success. Click here to stream this important webinar.]

Payers Struggle with ‘Explosion’ of Genetic Tests

In “UnitedHealth’s Optum to Offer Lab Test Management,” Dark Daily’s sister publication The Dark Report, covered Optum’s announcement that it had launched “a comprehensive laboratory benefit management solution designed to help health plans reduce unnecessary lab testing and ensure their members receive appropriate, high-quality tests.”

Optum sells this laboratory benefit management program to other health plans and self-insured employers. Genetic test management capabilities are part of that offering.

As part of its lab management benefit program, Optum is collaborating with Avalon on a new platform for genetic testing that will launch soon and focus on identifying test quality, streamlining prior authorization, and providing test payment accuracy in advance.

“Payers are struggling with the explosion in genetic testing,” Bush told Executive War College attendees. “They are truly not trying to hinder innovation.”

For clinical laboratory leaders reading this ebriefing, the takeaway is twofold: Genetic testing and resulting precision medicine efforts provide hope in more effectively treating patients. At the same time, the genetic test juggernaut has grown so large so quickly payers are finding it difficult to manage. Thus, it has become a source of continuous challenge for labs seeking reimbursements.

Heath information technology may help ease the situation. But, ultimately, stronger communication between labs and payers—including acknowledgement of what each side needs from a business perspective—is paramount. 

Scott Wallask

Related Information:

Executive War College Keynote Speakers Highlight How Clinical Laboratories Can Capitalize on Multiple Growth Opportunities

What Key Laboratory Leaders Will Learn at This Week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Ambulatory Seizure Forecasting with a Wrist-Worn Device Using Long-Short Term Memory Deep Learning

UnitedHealth’s Optum to Offer Lab Test Management

Learning from Payer Behavior to Increase Appeal Success

Clinical Laboratory and Pathology Leaders in Canada Gather to Assess New Diagnostic Technologies and Respond to the Acute Shortage of Medical Technologists

There was cautious optimism about the ability of Canada’s medical laboratories to innovate in ways that advance patient care, while recognizing the ongoing challenge of adequate lab staffing and budget constraints

TORONTO, ONTARIO, CANADA—This week, more than 150 leaders representing clinical laboratories, anatomic pathology labs, in vitro diagnostics (IVD) companies, and provincial health officials gathered for the first “Canadian Diagnostic Executive Forum” (CDEF) since 2019. It would be apt to say that the speakers objectively addressed all the good, the bad, and the ugly of Canada’s healthcare system and its utilization of medical laboratory testing services.

Over the two days of the conference, speakers and attendees alike concurred that the two biggest issues confronting clinical laboratories in Canada were inadequate staffing and an unpredictable supply chain. There also was agreement that the steady increase in prices, fueled by inflation, is exacerbating continuing cost increases in both lab salaries and lab supplies.

Canada’s Health System Has Several Unique Attributes

Canada’s healthcare system has two unique attributes that differentiate it from those of other nations. First, healthcare is mandated by a federal law, but generally each of Canada’s 13 provinces and territories operates its own health plan. Thus, the health system in each province and territory may cover a different mix of clinical services, therapeutic drugs, and medical procedures. The federal government typically pays 40% of a province’s health costs and the province funds the balance.

Second, it is a fact that 90% of the Canadian population lives within 150 miles of the United States border. Yet there are provinces with large populations that have geography that ranges from the US border to north of the Arctic Circle. These provinces have a major challenge to ensure equal access to healthcare regardless of where their citizens live.

During day one of the conference, several presentations addressed innovations that supported those labs’ efforts to deliver value and timely insights during the COVID-19 pandemic. For example, a lab team in Alberta launched a research study involving SARS-CoV-2 virus surveillance from the earliest days of the outbreak. This study was presented by Mathew Diggle, PhD, FRCPath, Associate Professor and Program Lead for the Public Health Laboratory (ProvLab) Medical-Scientific Staff at Alberta Precision Laboratories in Edmonton, Alberta. 

Study Designed to Identify Coinfections with COVID-19

While performing tens of thousands of COVID-19 tests from the onset of the pandemic, and identifying the emergence of variants, the ProvLab team also tracked co-infection involving other respiratory viruses.

“This is one of the largest eCoV [endemic coronavirus] studies performed during the COVID-19 pandemic,” Diggle said. “This broad testing approach helped to address a pivotal diagnostic gap amidst the emergence of a novel pathogen: cross-reactivity with other human coronaviruses that can cause similar clinical presentations. This broad surveillance enabled an investigation of cross-reactivity of a novel pathogen with other respiratory pathogens that can cause similar clinical presentations.

“Fewer than 0.01% of specimens tested positive for both SARS-CoV-2 and an eCoV,” he explained. “This suggested no significant cross-reactivity between SARS-CoV-2 and eCoVs on either test and provided a SARS-CoV-2 negative predictive value over 99% from an eCoV-positive specimen … The data we collected was highly compelling and the conclusion was that there was no coinfection.”

Kevin D. Orr

Chairing the two days of presentations at this weeks’ Canadian Diagnostic Executive Forum was Kevin D. Orr (above), Senior Director of Hospital Business at In-Common Laboratories. He also served on the program for this national conference serving clinical laboratories, anatomic pathology labs, and in vitro diagnostics (IVD) companies throughout Canada. This was the first gathering of this conference since 2019. Attendees were enthusiastic about the future of medical laboratory services in Canada, despite lab staffing shortages and rising costs due to inflation. (Photo copyright The Dark Report.)

Clinical Laboratory Regionalization in Quebec

One of Canada’s largest projects to regionalize and harmonize clinical laboratory services is proceeding in Quebec. Leading this effort is Ralph Dadoun, PhD, Project Director for OPTILAB Montreal, which is part of the Ministry of Health and Social Services in Quebec. The ambitious goal for this project is to move the 123 clinical laboratories within the province into 12 clusters. Initial planning was begun in 2013, so this project is in its ninth year of implementation.

During his presentation, Dadoun explained that the work underway in the 12 clusters involves creating common factors in these categories:

  • Uniform test names.
  • Common test codes, labels, test reporting format.
  • Common abbreviations.
  • Uniform quality indicators (e.g., nonconformities, specimen acceptability, etc.).
  • Implementation consistent with and respecting ISO-15189 criteria.

Another notable achievement in Quebec is the progress made to implement a common laboratory information system (LIS) within all 12 clusters. The first three laboratory clusters are undergoing their LIS conversions to the same platform during the next 180 days. The expectation is that use of a common LIS across all clinical laboratory sites in Quebec will unlock benefits in a wide spectrum of lab activities and work processes.

The 2022 CDEF featured speakers from most of the provinces. The common themes in these presentations were the shortage of lab personnel across all technical positions, disruptions in lab supplies, and the need to support the usual spectrum of lab testing services even as lab budgets are getting squeezed.

At the same time, there was plenty of optimism. Presentations involving adoption of digital pathology, advances in early disease detection made possible by new diagnostic technologies, and the expansion of precision medicine showed that clinical laboratories in Canada are gaining tools that will allow them to contribute to better patient care while helping reduce the downstream costs of care.

The Canadian Diagnostics Executive Forum is organized by a team from In-Common Laboratories in North York, Toronto, Ontario. Founded in 1967, it is a private, not-for-profit company that works with public hospitals and laboratory medicine providers. Information about CDEF can be found at its website, where several of this year’s presentations will be available for viewing.

Robert L. Michel 

Related Information:

Canadian Diagnostic Executive Forum 2022

Broad Respiratory Testing to Identify SARS-Cov-2 Viral Co-Circulation and Inform Diagnostic Stewardship in the COVID-19 Pandemic

Canadian Diagnostics Executive Forum Will Provide Firsthand Insights into How Clinical Laboratories Can Leverage Technology and Innovation to ‘Do More with Less’

Retail Giant Nordstrom Now Sells Viome Life Sciences’ Microbiome Testing Kit Online, Will Stock the Test Kit in Some Retail Locations Next Year

Although there are healthcare providers who see the potential in microbiome testing, many clinical laboratories are not yet ready to embrace microbiome-based testing

In an unlikely string of events, no less than Nordstrom, the national department store chain, announced in September that it would offer microbiome-based test claimed to “check gut health.” Apparently, its customers were interested in this clinical laboratory test, as the Nordstrom website currently indicates that the “Health Intelligence Test Kit by Viome” is already sold out!

What does it say about consumer interest in clinical laboratory self-testing that Nordstrom has decided to offer at-home microbiome tests to its store customers? Can it be assumed that Nordstrom conducted enough marketing surveys of its customers to determine: a) that they were interested in microbiome testing; and b) they would buy enough microbiome tests that Nordstrom would benefit financially from either the mark-up on the tests or from the derived goodwill for meeting customer expectations?

Whatever the motivation, the retail giant recently announced it had partnered with Viome Life Sciences to sell Viome’s microbiome testing kits to its customers online, and in 2022, at some Nordstrom retail locations. These tests are centered around helping consumers understand the relationship between their microbiome and nutrition.

Pathologists and clinical laboratories will want to track Nordstrom’s success or failure in selling microbiome-based assays to its consumers. Microbiomics is in its infancy and remains a very unsettled area of diagnostics. Similarly, Viome, a self-described precision health and wellness company that conducts mRNA analysis at scale, will need to demonstrate that its strategy of developing precision medicine diagnostics and therapeutics based on the human microbiome has clinical relevance.

Helping Consumers with ‘Precision Nutrition’

In a September news release, Viome founder and CEO Naveen Jain, a serial entrepreneur, said, “Both Viome and Nordstrom believe that true health and beauty start from within. There is no such thing as a universal healthy food or healthy supplement. What is right for one person can be wrong for someone else, especially when it comes to nutrition which is key to human longevity and vitality. Precision nutrition is the future!”

If you are not familiar with the term “Precision Nutrition” here’s how Harvard’s T.H. Chan School of Public Health describes it: “Precision nutrition may sound like a new fad diet, but it is actually a credible emerging area of research supported by the National Institutes of Health under the umbrella of precision medicine.

“Precision medicine seeks to improve the personalized treatment of diseases, and precision nutrition is specific to dietary intake. Both develop interventions to prevent or treat chronic diseases based on a person’s unique characteristics like DNA, race, gender, health history, and lifestyle habits. Both aim to provide safer and more effective ways to prevent and treat disease by providing more accurate and targeted strategies.

“Precision nutrition assumes that each person may have a different response to specific foods and nutrients, so that the best diet for one individual may look very different than the best diet for another.

“Precision nutrition also considers the microbiome, trillions of bacteria in our bodies that play a key role in various daily internal operations. What types and how much bacteria we have are unique to each individual. Our diets can determine which types of bacteria live in our digestive tracts, and according to precision nutrition the reverse is also true: the types of bacteria we house might determine how we break down certain foods and what types of foods are most beneficial for our bodies.”

Medical Laboratory Testing, not Guessing

Viome Life Sciences is a microbiome and RNA analysis company based in Bellevue, Wash. The test kit that Nordstrom is selling is called the Health Intelligence Test. It is an at-home mRNA test that can provide users with some insights regarding their health. Consumers use the kit to collect blood and fecal samples, then return those samples to Viome for testing.

In a press release announcing its collaboration with Nordstrom, Viome said, “In a world overwhelmed by information relating to diet and supplement advice, Viome believes in testing, not guessing and empowering its users with actionable insights. To date, Viome has helped over 250,000 individuals improve their health through precision nutrition powered by microbial and human gene expression insights.”

Nordstrom began offering Viome’s Health Intelligence Test kit for $199 on its website starting in September. As of this writing and noted above, the kits are sold out. Nordstrom plans to stock the kit in select stores starting in 2022.

Viome’s Health Intelligence Test kit

Viome’s Health Intelligence Test kit (above) looks at the microbiome to determine gut health, cellular health, healthy aging, immune health, and stress responses. Test results offer consumers personalized nutritional suggestions and recommendations for supplements, probiotics, and prebiotics based on an individual’s biology. Test are performed by Viome’s own clinical laboratories and results sent directly to Nordstrom’s customers. (Photo copyright: Viome Life Sciences.)

Individuals who purchase the test submit blood and stool samples to Viome’s lab which performs an analysis of gene activity patterns in the user’s cells and microbiome. Viome provides the results to consumers within two to three weeks.

“This partnership is a giant step towards making our technology more accessible, so people can understand what’s right for their unique body,” Jain said in the news release. “We are inspired each day by the incredible changes our customers are seeing in their health including improvements in digestion, weight, stress, ability to focus, and more.”

According to the news release, Viome conducted blind studies earlier this year that revealed significant successes based on their precision nutritional approach to wellness. Study participants, Viome claims, improved their outcomes to four diseases through nutrition:

Is Microbiome Diagnostics Testing Ready for Clinical Use?

Microbiomics is a relatively new field of diagnostics research. Much more research and testing will be needed to prove its clinical value and efficacy in healthcare diagnostics. Nevertheless, companies are offering microbiomics testing to consumers and that has some healthcare providers concerned.

In the GeekWire article, David Suskind, MD, a gastroenterologist at Seattle Children’s Hospital and Professor of Pediatrics at the University of Washington, described Viome’s study methodology as “questionable,” adding, “I think this is a very interesting and exciting space and I do think there are definite potential implications, down the road. [However] we are not there in terms of looking at microbiome and making broad recommendation for individuals, as of yet.”

Will at-home clinical laboratory testing kits that analyze an individual’s microbiome someday provide data that help people lead healthier lives and ward off diseases? That’s Jain’s prediction.

In an article published in Well+Good, Jain said, “COVID-19 has, of course, been such a dark time, but one positive that did come from it is that more people are taking control of their own health. I really believe that the future of healthcare will be delivered not at the hospital, but at home.”

If this collaboration between Nordstrom and Viome proves successful, similar partnerships between at-home diagnostics developers and established retail chains may become even more common. And that should be on the radars of pathologists and clinical laboratories.

—JP Schlingman

Related Information:

Test Order Page on Nordstrom Website for ‘Health Intelligence Test Kit by Viome’

Gut Check at Nordstrom: Retail Giant to Sell Microbiome Test from Seattle-Area Startup Viome

Viome Announces Retail Launch at Nordstrom

Nordstrom Is the Latest Retailer to Expand Its Health and Wellness Assortment

Viome’s At-Home Microbiome Testing Kit Hits Nordstrom’s Digital Shelves

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