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Amazon Signs Agreement to Purchase One Medical for $3.9 Billion, Aims to “Reinvent” Healthcare

Company also launches Amazon Clinic virtual healthcare services and announces it will terminate Amazon Care by end of year

Clinical laboratory leaders and pathologists may understandably struggle to keep abreast of Amazon’s moves in the healthcare space. For years, Amazon has tried to develop medical services that disrupt the US healthcare industry in the same way its digital book business upended traditional book publishing. It is clear that Amazon is heavily investing in healthcare ventures that deliver what it believes are better alternatives to existing primary care, clinical laboratory, and retail pharmacy options.

Now, the Seattle-based global e-commerce company has announced plans to acquire One Medical, a membership-based primary care organization, for $3.9 billion according to a news release.

Headquartered in San Francisco, One Medical has primary care offices in 12 major US markets and offers its members 24/7 virtual care, according to the company’s website.

Neil Lindsay

“We think healthcare is high on the list of experiences that need reinvention,” said Neil Lindsay (above), SVP of Amazon Health Services, in a news release announcing the planned acquisition of One Medical. “We love inventing to make what should be easy easier, and we want to be one of the companies that helps dramatically improve the healthcare experience over the next several years,” he added. However, clinical laboratory leaders have watched Amazon’s efforts to disrupt healthcare come and go. (Photo copyright: Advertising Age/Daniel Berman.)

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As One Medical Grows, Amazon Launches Virtual Care Clinic

“One Medical’s philosophy is rooted in quality care, patient-centered design, and a smart application of technology,” Greg Hayes, MD, District Medical Director for One Medical, Preston Center, Dallas, told Texas News.

For its part, One Medical, which currently has more than 125 clinic locations, sees opportunity to grow its services as part of Amazon (NASDAQ:AMZN). “Joining Amazon is a tremendous next step in innovating and expanding access to high-quality, high-value healthcare,” said Amir Dan Rubin, One Medical Chief Executive Officer, in a blog post.

One Medical (NASDAQ:ONEM) is the operating name for 1Life Healthcare, Inc., a chain of primary care clinics that has 815,000 members, a 14% increase over last year. According to a news release on the company’s third quarter 2022 financial results, its revenue was $261.4 million, up 73% over the same period last year. More than 8,000 companies and organizations work with One Medical, the company’s website notes.

Meanwhile, Amazon is also launching Amazon Clinic, a virtual health service “that delivers convenient, affordable care for common conditions” to people in 32 states, an Amazon news release states.

Amazon Clinic offers virtual care services for 20 common conditions including allergies, acne, migraines, and urinary tract infections. Patients complete a questionnaire through a message-based portal prior to meeting with clinicians.

Clinical laboratory managers and pathologists will want to note that Amazon Clinic will need medical laboratory testing performed to properly diagnose patients and determine the best treatments. Since Amazon Clinic will be a virtual care service, Amazon can be expected to explore such options as sending collection kits directly to individuals using the virtual care service, allowing them to collect needed samples that can be returned to traditional clinical laboratories for testing. Amazon’s existing courier and delivery service would make it easy for the internet giant to deliver either specimen collection kits or home-test kits to obtain the necessary diagnostic data.

Patients needing prescriptions can use the company’s online pharmacy Amazon Pharmacy, or other retail pharmacies, noted Becker’s Hospital Review.

“Amazon Pharmacy and One Medical (once the deal closes) are two key ways we’re working to make care more convenient and accessible. But we also know that sometimes you just need a quick interaction with a clinician for a common health concern. … That’s why today were also introducing Amazon Clinic, a message-based virtual care service,” Amazon said in its news release.

What’s Next for Amazon?

Separately, Amazon announced it will terminate Amazon Care at the end of 2022. Amazon Care is a virtual and in-home care service it launched in 2019.

In “Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing,” Dark Daily reported how Amazon was piloting Amazon Care as a benefit for its 53,000 Seattle-area employees and their families, and how it could indicate that the world’s largest online retailer was planning a move into the primary care space.

However, in a 2022 internal email, senior vice president of Amazon Health Services Neil Lindsay said Amazon Care wasn’t a sustainable, long-term solution for its enterprise customers, according to Fierce Healthcare.

“This decision wasn’t made lightly and only became clear after many months of careful consideration,” he said. “Although our enrolled members have loved many aspects of Amazon Care, it is not a complete enough offering for the large enterprise customers we have been targeting and wasn’t going to work long-term.”

Will Amazon Provide Clinical Laboratory Services?

Now that Amazon is set with primary care, pharmacy, and virtual health services, might it next explore medical laboratory testing or other diagnostics relationships?

In “Amazon Now Interested in Home Testing Services,” Dark Daily’s sister publication The Dark Report noted that actions Amazon took during the COVID-19 pandemic suggest it may be “serious about clinical laboratory services.”

The Dark Report was alluding to US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of the Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, which was to be performed at clinical laboratories “designated by STS Lab Holdco (a subsidiary of Amazon.com Services LLC) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests,” according to Healthcare Purchasing News.

However, on July 19, the FDA revoked its EUA of the Amazon test.

But this apparently has not slowed Amazon’s drive to gain a foothold in the primary care and virtual health services market. Therefore, clinical laboratory leaders should advance their outreach to healthcare providers who are caring for Amazon employees, customers, and soon patients, in new ways and offer their lab services.   

—Donna Marie Pocius

Related Information:

Amazon and One Medical Sign an Agreement for Amazon to Acquire One Medical

Amazon and One Medical Have Landed in Dallas

What is Amazon Clinic?

Amazon Care Shutting Down End of 2022

One Medical Announces Results for Third Quarter 2022

Update from One Medical on Agreement to be Acquired by Amazon

Amazon Clinic Makes Debut: Six Things to Know

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services that Include Clinical Laboratory Testing

Amazon Now Interested in Home Testing Services

Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 Receives FDA EUA

Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability

Walmart’s Health and Wellness Chief Discusses Retail Giant’s Move to Healthcare/Telehealth Provider, a Step with Implications for Clinical Laboratory Testing

Retail giant now has primary care clinics at stores in five states, but the rollout has not gone smoothly

Healthcare is increasingly being driven by consumerism and one clear sign of this trend is Walmart’s ambitious plan to open health clinics at its retail locations. The retail giant set its plans in motion in 2019 with its first primary care site in a suburban Atlanta store, however, the rollout since then has presented certain challenges.

Nevertheless, the trend of placing nearly full-service primary care clinics in retail locations continues. Clinical laboratories in these areas need strategies to serve customers accessing healthcare through these new channels, particularly as Walmart and the national retail pharmacy chains continue to expand the clinical services offered in their retail stores.

“Consumer engagement is a huge part of healthcare, [yet it is also a] gap for us in healthcare,” cardiologist and Walmart VP of Health and Wellness Cheryl Pegus, MD, told Modern Healthcare. “Healthcare is incredibly complicated,” she added. “And where we are in healthcare today is not in having great treatments. It’s not in having evidence-based medicine. It’s understanding how we engage consumers.”

The company also entered the telehealth business with last year’s acquisition of multispecialty telehealth provider MeMD.

“Telehealth offers a great opportunity to expand access and reach consumers where they are and complements our brick-and-mortar Walmart Health locations,” said Pegus in a Walmart new release announcing the acquisition. “Today people expect omnichannel access to care and adding telehealth to our Walmart healthcare strategies allows us to provide in-person and digital care across our multiple assets and solutions.”

Currently, Walmart Health centers only operate in Georgia, Florida, Illinois, and Arkansas. But telehealth enables Walmart “to provide virtual healthcare across the country to anyone,” Pegus said. With both offerings, “we’re really attempting to allow people to get healthcare the way they need it without disrupting the rest of their life.” Many users of these services are Walmart “associates,” she added, using the company’s term for its retail employees.

Cheryl Pegus, MD
 
“In this country, about 25% of people don’t have a primary care physician,” cardiologist Cheryl Pegus, MD (above), Walmart’s VP of Health and Wellness, told Medscape. “So, your options for being able to solve in real time something that will help you, they’re quite limited. What we’re trying to do is give those options. We’re not trying to take away emergency rooms, or healthcare systems, or existing primary care. We’re asking, how do we expand that infrastructure so that people get care when they need it?” And this includes clinical laboratory testing, radiology, and telehealth services as well. (Photo copyright: Walmart.)

Large Portfolio of Healthcare Offerings

Pegus joined Walmart (NYSE:WMT) in December 2020 to oversee a portfolio that now includes more than 4,700 pharmacies and 3,400 Vision Centers, in addition to the telehealth operation and the Walmart Health centers. She was previously chief medical officer at Walgreens and Cambia Health Solutions and worked in private practice as a cardiologist.

The retail giant opened its first Walmart Health center in Dallas, Ga., an Atlanta suburb, in September 2019, followed by additional centers in Georgia, Arkansas, and Illinois.

Earlier this year, it opened five new clinics in northern and central Florida with plans for at least four more in the Jacksonville, Orlando, and Tampa areas, according to a press release. Each health center is adjacent to a Walmart retail location.

These centers offer a range of primary care medical services, including:

  • physicals,
  • injury care,
  • immunizations,
  • radiology, and
  • care for chronic health conditions.
One of the first health clinics established by Walmart
Pictured above is one of the first health clinics established by Walmart. This location is in a western Atlanta suburb. Note that the services advertised include more than just primary care. Also offered are “labs and X-ray,” along with dental, hearing, optometry, and counseling. Clinical laboratory managers and pathologists may want to monitor whether consumers embrace primary care delivered from clinics located in retail stores. (Photo copyright: Georgia Health News.)

As Dark Daily reported in May 2020, the Walmart Health centers also offer clinical laboratory testing at cut-rate prices, such as:

  • $10 for a lipid test,
  • $10 for Hemoglobin A1c, and
  • $20 for a strep test.

On the Walmart Health website, patients can enter their Zip code to view a list of Walmart Health clinics in their area, including links to price lists.

Walmart’s Expansion into Healthcare Not Without Problems

In “Walmart to Open 4,000 Healthcare ‘Supercenters’ by 2029 That Include ‘Comprehensive’ Clinical Laboratory Services,” Dark Daily covered how Walmart was poised to become a much bigger healthcare player with an expanded menu of clinical laboratory testing services including EKGs, vision care, dental care, and more for children and adults.

However, the company’s expansion into healthcare has not gone smoothly. In 2018, the Walmart board signed off on a plan to open 4,000 health centers by 2029, Insider reported. By the end of 2021, Walmart expected to have 125 health centers in operation, but as of June 2022, the Walmart Health website listed only 25 locations, mostly in Georgia.

Citing anonymous sources, Insider reported problems that include “leadership changes, competing business priorities brought on by the coronavirus pandemic, and the complexity of scaling a massive healthcare operation.”

In Sept. 2021, Insider further reported that the clinics were experiencing operational difficulties including hidden fees and billing problems. One culprit, the story suggested, was the company’s electronic health record (EHR) software. That same month, Walmart announced it would adopt the Epic health records system, beginning with the opening of new clinics in Florida locations.

Pegus’ arrival at Walmart appears to be part of a management shakeup. In January 2022, Insider reported that she had assembled a new executive team, with David Carmouche, MD, Senior VP, Omnichannel Care Offerings, overseeing the health centers and telehealth operations. By then, the original executives leading the rollout of the health centers had all left, Insider reported. Carmouche was previously an executive VP with Ochsner Health in New Orleans.

Partnership with Quest Diagnostics

Meanwhile, in January, Walmart announced a deal with Quest Diagnostics that allows consumers to order more than 50 lab tests through The Wellness Hub on Walmart.com, which is separate from the Walmart Health website. The tests cover “general health, digestive health, allergy, heart health, women’s health, and infectious disease,” according to a press release announcing the partnership.

Consumers can order at-home test kits for certain conditions or set up appointments for tests at Quest Patient Service Centers. The tests on the Walmart/QuestDirect website include:

  • COVID-19 Active Infection ($119+)
  • COVID-19 Antibody Test ($69)
  • Cholesterol Panel ($59)
  • Complete Blood Count ($59)
  • Comprehensive Metabolic Panel ($49)
  • CRP Inflammation Marker ($59)
  • Diabetes Management ($69+)
  • Diabetes Risk ($99+)
  • Food Allergy Test Panel ($209)
  • Chickenpox ($59)

The website also offers a combined Basic Health Profile with CBC, CMP, cholesterol panel, and urinalysis for $149. “Each purchase is reviewed and, if appropriate, ordered by a licensed physician,” the press release states.

What does all this mean for clinical laboratories? “They need to recognize that the Millennials and Gen Zs are driving a consumer revolution in healthcare,” said Robert Michel, Publisher and Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

“Walmart was early to recognize and respond to this, in part because it employs 1.3 million Americans, many of whom are Gen Y and Gen Z and quick to use telehealth and similar virtual health services,” he added.

Clinical laboratory leaders need to understand this trend and develop strategies to attract and serve new patients who are willing to access healthcare virtually, while still needing to provide blood and other specimens for the lab tests ordered by their providers.

Stephen Beale

Related Information:

Q/A with Dr. Cheryl Pegus of Walmart: ‘Consumer Engagement Is a Huge Part of Healthcare’

Nine Numbers That Show How Big Walmart’s Role in Healthcare Is

Walmart Health Opens Two More Locations in Chicago

Change Makers: Dr Cheryl Pegus on How Walmart Is Rethinking Health

Walmart to Open Two Health Clinics in Rogers, Fort Smith

Walmart Deepens Healthcare Offering with Lab Test Partnership

Walmart Tests Leap into Healthcare Business by Opening Second Clinic

Walmart to Open 4,000 Healthcare ‘Supercenters’ by 2029 That Include ‘Comprehensive’ Clinical Laboratory Services

Despite Technical Challenges During COVID-19 Pandemic, Healthcare Networks Plan to Increase Investment in Telehealth Technologies

Survey shows more than 50% of hospitals and health systems plan to increase virtual care services within two years, a development that can change how patients access clinical laboratory testing services

If anything positive came out of the COVID-19 pandemic, it’s the growing acceptance by physicians and health payers of telehealth—including telepathology, teleradiology, and other types of virtual doctor visits—as a way for patients to meet with their physicians in place of in-office healthcare.

In earlier coverage about the rapid adoption of telehealth and virtual doctor visits, Dark Daily has observed that this trend creates a unique challenge for clinical laboratories. If the patient has a virtual consultation with his or her physician, how would a clinical laboratory get access to this patient to do a venipuncture and collect the samples necessary to perform the medical laboratory tests ordered by the physician?

Additionally, the path forward in telehealth may have other barriers to overcome. In “The Pandemic Made Telemedicine an Instant Hit. Patients and Providers Feel the Growing Pains,” Kaiser Health News (KHN) suggested that the virtual office visit may not have been as easy for patients as news headlines made them appear to be.

Nevertheless, according to multiple reports, healthcare providers are planning to increase investment in telehealth technologies.

Disparate Technologies Led to Technical Difficulties for Virtual Healthcare Providers

The terms telemedicine and telehealth are often used interchangeably. However, according to the American Academy of Family Physicians (AAFP), there are subtle differences worth noting.

Telehealth is a broad term which refers to “electronic and telecommunications technologies and services used to provide care and services at-a-distance [while] telemedicine is the practice of medicine using technology to deliver care at a distance.

“Telehealth is different from telemedicine in that it refers to a broader scope of remote health care services than telemedicine. Telemedicine refers specifically to remote clinical services, while telehealth can refer to remote non-clinical services,” the AAFP notes.

Kelly Lewis, former Vice President of Revenue Strategy and Enablement at telehealth provider Amwell, told Healthcare IT News (HIT News) that “the COVID-19 pandemic caused telehealth adoption to skyrocket.

However, “Because much of this adoption was driven out of an abundance of necessity, there was little time for organizations to think strategically about their technology investments,” she added.

“With urgency at a high, payers, provider organizations and clinicians all turned to the quickest options available so patients could continue to get care. The result, however, was what we are calling platform ‘sprawl’—the use of a number of disparate solutions that are leading to a confusing and frustrating care delivery system and experience.”

Nevertheless, according to a survey conducted by HIT News and HIMSS Analytics, “More than half (56%) of hospital and health system leaders say they are planning to increase their investment in telemedicine during the next two years.” This, “shows that the huge surge in and mainstreaming of telehealth during the ongoing pandemic has caused the C-suite and other healthcare leaders to embrace the technology that has for so long existed on the periphery of medicine,” HIT News noted.

“The clear message is that telehealth is here to stay and will continue to expand,” Lewis told HIT News, adding, “The majority of payers without virtual care offerings also reported planning to add them in the next 24 months.”

Kelly Lewis

“Clinicians agree that moving toward a fully integrated telehealth platform would be beneficial. More than 80% believe investing in a fully integrated virtual or hybrid care system would have a positive impact on clinical outcomes and patient experiences,” Kelly Lewis (above), former VP at telehealth provider Amwell, told Healthcare IT News. Considering the growing demand for telehealth, pathologists and clinical laboratories will need a strategy for supporting virtual healthcare providers. (Photo copyright: Healthcare IT News.)

The HIT News/HIMSS Analytics survey findings suggest telehealth will transition as providers aim for “smart-growth” instead of “pandemic-fueled expediency,” Becker’s Hospital Review reported.

Survey respondents expressed positive attitudes about telehealth:

  • 56% of healthcare leaders plan to increase investment in virtual care over the next two years.
  • 80% of respondents noted “very” or “extremely” important telehealth factors are integrating with existing workflows, fast video connections, and reducing administrative burden.
  • 77% called telehealth platform integration with the electronic health record (EHR) “very” or “extremely” important.
  • 80% envision positive clinical outcomes and patient experiences from a fully integrated telemedicine platform.
  • 75% of payers said a single digital platform has potential to streamline member experiences.

Investors Eye Telehealth

Healthcare providers are not the only organizations mining telehealth’s potential. Worldwide telehealth investments grew to $5B in the second quarter of 2021. This represented a 169% increase from the same time in 2020, reported an American Hospital Association Center for Health Innovation Market Scan that covered a CB Insights report, titled, “State of Telehealth Q2’21 Report: Investment and Sector Trends to Watch.”

“With telehealth visits stabilizing at roughly 10 times pre-pandemic levels, digital transformation initiatives are rising across the field. As a result of the pandemic, 60% of healthcare organizations are adding new digital projects, with telemedicine becoming a higher priority for 75% of executives (vs. 42% in 2019) to improve the patient experience,” the AHA reported.

As Dark Daily covered in “Cigna Subsidiary Evernorth Acquires MDLIVE as Demand for Telehealth Grows Among Insurers and Healthcare Consumers,” the COVID-19 pandemic has elevated virtual care into the mainstream, creating opportunities to increase access to care, including clinical laboratory testing, and drive down healthcare costs.

Medical laboratories and anatomic pathology groups are advised to keep pace with the changing healthcare landscape which increasingly puts a premium on remote and virtual visits. This has become even more critical as healthcare providers and investors infuse more capital into telehealth technology.

As physicians expand telemedicine virtual office visits post-pandemic, a clinical laboratory strategy to reach patients and acquire specimens will be required.

—Donna Marie Pocius

Related Information:

The Pandemic Made Telemedicine an Instant Hit. Patients and Providers Feel the Growing Pains

New HHS Study Shows 63-fold Increase in Medicare Telehealth Utilization During Pandemic

Most Provider Organizations Boosting Telehealth Investments, Survey Finds

Amwell Industry Telehealth Survey Paints Picture of an Integrated Streamlined Digital Care Future

Insights From Amwell’s 2021 Survey of Health Plans, Hospitals and Health Systems, and Clinicians

Telehealth Investment Shifts Signal Market Maturity

CBC Insights: Telehealth Trends 2021

Cigna Subsidiary Evernorth Acquires MDLive as Demand for Telehealth Grows Among Insurers and Healthcare Consumers

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

Demographic shifts are most acute in Europe and East Asia but could be a harbinger of things to come for US healthcare as well

Across the globe, major shifts in many countries’ demographics are starting to drive notable changes in how healthcare is delivered in these nations. Having fewer pediatric patients and more senior citizens is fundamentally altering what types of tests are in greatest demand from the medical laboratories in these countries. It is the population trend writ large on a global scale.

For example, in countries as diverse as Sweden, Hungary, Japan, and South Korea, birthrates are declining as fewer young people decide to have kids, or they choose to have smaller families. Thus, demand for pediatric care is declining in those countries.

Meanwhile, populations around the world continue to age as greater numbers of people reach their retirement years. Not only does this create the need to expand medical services designed to serve the elderly, but there are important economic consequences. That’s because each wave of retirees leaves fewer people in the workforce to support the healthcare of ever-growing numbers of senior citizens.

According to The New York Times (NYT), this trend is likely to accelerate. In “Long Slide Looms for World Population, with Sweeping Ramifications,” the paper reported that “All over the world, countries are confronting population stagnation and a fertility bust, a dizzying reversal unmatched in recorded history that will make first-birthday parties a rarer sight than funerals, and empty homes a common eyesore.”

The NYT added that, “With fewer births, fewer girls grow up to have children, and if they have smaller families than their parents did—which is happening in dozens of countries—the drop starts to look like a rock thrown off a cliff.”

In countries such as the US, Canada, and Australia, this is partially mitigated by immigration, the NYT reports. However, some nations, such as Germany and South Korea, have instituted programs aimed at boosting birthrates, though with varying degrees of success.

According to demographer Frank Swiaczny, Dr. rer. nat., Senior Research Fellow at the Federal Institute for Population Research in Germany, countries around the world—especially in Europe and East Asia—“need to learn to live with and adapt to decline.”

“A paradigm shift is necessary,” he told the NYT.

An Aging Nation

The graphic above, taken from the US Census Bureau’s 2018 report, “The Graying of America: More Older Adults than Kids by 2035,” illustrates the rate at which America’s elder population is catching up with the rest of the world. It will soon exceed younger portions of the population, thus shifting demand for healthcare from pediatrics to geriatrics. Anatomic pathology groups and clinical laboratories will be impacted by this trend. (Graphic copyright: US Census Bureau.)

Elder Population Growth: Academics Take Notice

Healthcare scholars also have been looking at the topic of demographic shift. A recent commentary in Health Affairs, titled “Actualizing Better Health and Health Care for Older Adults,” focused on the policy implications for senior care.

The authors, which included Terry Fulmer PhD, RN, FAAN, and John Auerbach, Director of Intergovernmental and Strategic Affairs at the CDC, noted that in 2018, adults 65 or older were 15.6% of the population. This will rise to 20% by 2030, when, according to the authors, seniors will outnumber the portion of the population that is younger than age five.

Fulmer is President of the John A. Hartford Foundation, which is dedicated to improving care for older adults, and until May, Auerbach was President and CEO of Trust for America’s Health (TFAH).

They recommended six broad policy goals:

  • Foster an “expanded and better-trained workforce” to care for older adults, through enhanced training as well as “scholarships, loan forgiveness, and clinical internships.”
  • Adapt the public health system to account more for the needs of an aging population, such as by “improved coordination and collaboration with Area Agencies on Aging and key healthcare providers.”
  • Address disparities and inequities in healthcare access, such as social isolation “caused or exacerbated by social, economic, and environmental conditions.”
  • Facilitate advances in telehealth and other technologies to improve care delivery. “The lack of access to technology, low digital health literacy, and design barriers in patient portals and apps have disproportionately affected older adults, especially those in underserved communities,” the authors wrote.
  • Improve palliative and end-of-life care. “Many older adults are living with serious illness,” the authors wrote, and “most will live for years with their illnesses, resulting in a high burden of physical and psychological distress, functional dependence, poor quality of life, high acute care use, loss of savings, and caregiver distress.”
  • Reform long-term care, by improving conditions in long-term care facilities and making it easier for older adults to stay at home.

The authors also urged a move away from “traditional fee-for-service Medicare” through “policy changes such as bundled, capitated, and other value-based payments.”

A perspective in the journal NPJ Urban Sustainability, titled “Ageing and Population Shrinking: Implications for Sustainability in the Urban Century,” notes that these trends have led some cities or countries to adopt technological innovations in healthcare, such as “socially assistive robots and virtual entertainment for mental health, roadside AI services for healthcare, and a series of innovations for house-based healthcare, digital nursing, and monitoring.”

Aging population of Italy vs. Nigeria

The graphic above, taken from PopulationPyramid.net, illustrates the stark differences in the age of populations in two countries at opposite ends of the progressing demographic shift. Italy’s population pyramid (left) shows how the senior population makes up a substantial proportion of total population, while Nigeria’s 2030 population pyramid (right) shows the classic pyramid of a wide base of younger people trailing off to a small number of the elderly at the top of the pyramid. Medical laboratories in those nations will continue to be affected by how these demographic shifts taking place worldwide are changing the type of healthcare in highest demand. (Graphic copyright: PopulationPyramid.net.)

Impact on Pediatrics

At the other end of the age spectrum, a recent presentation from the American Academy of Pediatrics noted a 13% decline in the US birthrate between 2007 and 2019. But a white paper from physician search firm Merritt Hawkins suggests this has not necessarily resulted in reduced demand for pediatric services, at least not in the US.

Despite the decline, “there are still about four million births in the US annually, and immigration adds to the number of children in the population,” the white paper notes. Even rural areas with aging populations “have far fewer pediatricians per capita than they require.”

However, according to The New York Times, in South Korea, “expectant mothers in many areas can no longer find obstetricians or postnatal care centers.” And the town of Agnone, Italy, no longer has a maternity ward because the number of births—just six this year—is below the national minimum.

This is important to note. If there are developed countries around the world where demographics point to a steady decline in population, then the type of healthcare provided will be different than what is currently used. Clinical laboratories and pathology groups in those regions can expect changes and should prepare for them.

Stephen Beale

Related Information:

Long Slide Looms for World Population, with Sweeping Ramifications

Aging and Population Shrinking: Implications for Sustainability in the Urban Century

Actualizing Better Health and Health Care for Older Adults

US Birth Rate Falls to Lowest Point in More than a Century

FDA Expands Approval of Gastric Emptying Breath Test for Gastroparesis to Include At-home Administration Under Virtual Supervision

It may not be a boom trend, but more non-invasive diagnostic tests are coming to market as clinical laboratory tests that use breath as the specimen

Here’s a development that reinforces two important trends in diagnostics: non-invasive clinical laboratory assays and patient-self testing. Recently, the FDA expanded the clearance of one diagnostic test to allow patients to collect their own breath specimen at home under the supervision of the test manufacturer’s telehealth team.

The C-Spirulina Gastric Emptying Breath Test (GEBT) breath test from Cairn Diagnostics initially received federal Food and Drug Administration (FDA) approval in 2015. At that time, the test was required to be administered “at a physician’s office, a laboratory collection center, or in a tertiary care setting,” according to a 2016 news release.

Recently, however, the FDA announced it has “expanded the approval of the company’s 13C-Spirulina Gastric Emptying Breath Test (GEBT) to now include ‘at home’ administration under virtual supervision of Cairn Diagnostics.”

Self-administration of at-home tests by patients guided virtually by healthcare professionals is a major advancement in telehealth. But will this virtual-healthcare method be popular with both patients and their physicians?

Clinical Laboratory Diagnostics and Telehealth

Spurring a far greater acceptance of telehealth among patients and healthcare providers is one of the many ways the COVID-19 pandemic has impacted healthcare.

“Telehealth, particularly during the COVID-19 pandemic, has emerged as a preferred option for healthcare providers,” noted Kerry Bush, President and COO of Cairn Diagnostics, in a 2021 news release

Cairn’s GEBT detects gastroparesis, a disease which, according to the NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), affects 50 people in every 100,000. According to the CDC, it is also sometimes a complication of diabetes. Symptoms include nausea, heartburn, bloating, a feeling of fullness long after eating a meal, vomiting, belching, and pain in the upper abdomen, the NIDDK notes.

In people with gastroparesis—sometimes called “delayed gastric emptying”—muscles that normally move food from the stomach to the small intestine do not work as they should, and the food remains in the stomach for too long. The traditional diagnostic tool used to diagnose gastroparesis is scintigraphy. The patient consumes a meal that has radioactive material mixed in and the digestion process is observed using a nuclear medicine camera as the material is eliminated through the bowels.

Cairn Diagnostics’ C-Spirulina Gastric Emptying Breath Test

Cairn Diagnostics’ C-Spirulina Gastric Emptying Breath Test (above) recently received an expansion to its initial 2015 FDA approval that enables patients to self-administer the test at-home while being virtually guided by the company’s telehealth team. GEBTs are interpreted by CLIA-certified clinical laboratories and the results sent to patients’ doctors within 24-48 hours after testing. (Photo copyright: Cairn Diagnostics.)

Virtual Telehealth GEBT versus Scintigraphy

The telehealth process for Cairn Diagnostic’s Gastric Emptying Breath Test (GEBT) differs significantly from traditional scintigraphy testing. Once a physician prescribes the test, Cairn’s telehealth team contacts the patient to describe the virtual process. The team then ships the at-home test kit to the patient. To complete the testing, Cairn provides the patient with a web-based link to a secure audio/video platform.

During administration of the GEBT, a Cairn technician coaches the patient and supervises via video. Once the test is complete, the patient returns the breath samples to the CLIA-certified clinical laboratory by overnight courier. The test results are sent to the prescribing physician within 24-48 hours after the lab receives the samples.

Discovering New Uses for Breath as a Specimen for Clinical Laboratory Testing

For obvious reasons, patients prefer diagnostics that use specimens obtained noninvasively. GEBT is the latest in a growing list of diagnostic tests that use breath as a specimen.

For example, at Johns Hopkins clinicians employ breath testing to diagnose several conditions, including:

Each of these tests involves the patient consuming a particular substance, technicians capturing breath samples at certain intervals, and clinical laboratory personnel analyzing the samples to look for indicators of disease or intolerance.

New Types of Breath Tests

Breath samples are commonly used to diagnose gastrointestinal issues, but researchers also are seeking methods of using them to diagnose and monitor respiratory conditions as well.

In a recent study published in Nature Nanotechnology, scientists explored how breath can be used to monitor respiratory disease, noting that although breath contains numerous volatile metabolites, it is rarely used clinically because biomarkers have not been identified.

“Here we engineered breath biomarkers for respiratory disease by local delivery of protease-sensing nanoparticles to the lungs. The nanosensors shed volatile reporters upon cleavage by neutrophil elastase, an inflammation-associated protease with elevated activity in lung diseases such as bacterial infection and alpha-1 antitrypsin deficiency,” the researchers wrote.

Indeed, the search for new ways to use breath as a biological sample is being pursued by numerous groups and organizations. Owlstone Medical in the UK, for example, is developing breathalyzer tests for the detection of cancer as well as inflammatory and infectious disease.

“Exhaled breath is more than just air,” notes the company’s website. “It contains over 1,000 volatile organic compounds (VOCs) as well as microscopic aerosol particles, also known as respiratory droplets, originating from the lungs and airways.”

Analyzing breath allows for the:

  • investigation of biomarkers of disease,
  • patient stratification by phenotype,
  • detection and monitoring treatment response, and
  • measurement of exposure to harmful substances.

In fact, so many studies on using breath as a specimen have been conducted that in “Breath Biomarkers in Asthma: We’re Getting Answers, But What Are the Important Questions?” researchers Peter J. Sterk, PhD, Professor of Pulmonology at Amsterdam University Medical Centers, and immunity and respiratory medicine specialist Stephen J. Fowler, MD, FRCP, Professor of Respiratory Medicine at the University of Manchester in the UK suggested that systematic reviews are now feasible. They published their article in the European Respiratory Journal.

“Whilst we are still in this discovery stage it is time to refine our study designs so that we can make progress towards tailored clinical application,” they wrote. “Breathomics is perhaps at the ‘end of the beginning’ for asthma at least; it has a ‘sexy’ name, some promising and consistent findings, and the key questions are at least being recognized.”

Better for Patients, Clinicians, and Clinical Laboratories

Virtual telehealth tests, ordered by physicians, administered at home, and interpreted in CLIA-certified clinical laboratories, is a trend pathologists may want to watch carefully, along with the development of other tests that use human breath as the specimen. 

Less invasive, more personalized diagnostic tools that can be administered at home are better for patients. When those tools also provide detailed information, clinicians can make better decisions regarding care. Clinical laboratories that approach the use of at-home tests creatively, and which can accurately and quickly process these new types of tests, may have a market advantage and an opportunity to expand and grow.

Dava Stewart

Related Information:

Cairn Diagnostics Approved for At-Home Admin of Breath Test

Cairn Diagnostics Delivers Virtual Administration of Its Novel 13C-Spirulina Gastric Emptying Breath Test

Cairn Diagnostics Launches FDA-Approved Spirulina Gastric Emptying Breath Test for Gastroparesis

NIDDK: Definition and Facts for Gastroparesis

CDC: Diabetes and Digestion

Nuclear Medicine Gastric Emptying

Johns Hopkins: Gastroenterology and Hepatology

Nature: Engineering Synthetic Breath Biomarkers for Respiratory Disease

A Breathalyzer for Disease

Breath Biopsy—Biomarkers on Exhaled Breath

Breath Biomarkers in Asthma: We’re Getting Answers, But What Are the Important Questions?

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