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Costco Begins Selling an At-Home Self-Collection COVID-19 Test Kit; One of 12 Kits That Have Received FDA Emergency Use Authorization

It’s the latest example of how the ongoing SARS-CoV-2 pandemic is making it possible for new competitors to enter the clinical laboratory marketplace

In response to increasing demand for COVID-19 testing, warehouse retailer Costco (NASDAQ:COST) is seizing the opportunity to sell at-home saliva self-collection test kits to its customers. It makes Costco the latest company to enter the market for SARS-CoV-2 testing and compete against clinical laboratories.

And these non-invasive tests—which are as simple as spitting saliva into a container and mailing it to a medical laboratory—may be more effective at detecting the SARS-CoV-2 coronavirus than uncomfortable nasal swabs. 

Costco is selling its COVID-19 Saliva PCR Test Kit for $129.99 ($139.99 with video observation). Included in the price is a self-collection device, a biohazard bag, a sticker for personal data, and a box for shipping the saliva to a medical laboratory.

The test is actually P23 Labs’ TaqPath SARS-CoV-2 assay and will be administered by Azova, a digital health services provider. P23 says their test has a 98% sensitivity and 99% specificity, according to Business Insider.

The Costco P23 test kit  from Thermo Fisher Scientific
The Costco P23 test kit above, “uses parts from Thermo Fisher Scientific and works with collection kits made by testing companies Everlywell and OraSure Technologies, according to the FDA and a P23 spokesperson,” Business Insider reported. “Samples are tested in [P23’s] lab in Little Rock, Arkansas.” (Photo copyright: Costco.)

Saliva-Collection Kits Gain Popularity and FDA Emergency Use Authorizations

P23 Labs’ assay is one of 12 COVID-19 home tests that have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Three of which use saliva specimens.

The FDA’s EUA authorization summary for the P23 assay states it is “for use with saliva specimens that are self-collected at home or in a healthcare setting with or without the supervision and/or assistance of [a healthcare provider (HCP)], by individuals using the P23 At-Home COVID-19 Test Collection Kit, when determined to be appropriate by an HCP based on the results of a COVID-19 medical questionnaire. This test is also for use with nasal swab specimens that are self-collected at home or in a healthcare setting with or without the supervision and/or assistance of an HCP by individuals.”

In a news release announcing the first diagnostic test using saliva specimens, oncologist and FDA Commissioner Stephen Hahn, MD, said that “Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This (saliva sample collection) provides an additional option for the easy, safe, and convenient collection of samples required for testing without traveling to a doctor’s office, hospital, or testing site.” That test was manufactured by Clinical Genomics laboratory of Rutgers New Jersey Medical School.

Below is a list from Business Insider for at-home self-collection SARS-CoV-2 coronavirus tests that have received an FDA EUA. Most can be ordered online, and prices range from $109 to $149, which may be covered by insurance depending on the health plan.

Saliva coronavirus home tests:

Nasal swab coronavirus home tests:

Yale Study Indicates Saliva Tests Have Greater Detection Sensitivity over Swab

Should consumers choose COVID-19 saliva tests over nasal cavity swab tests? Maybe.

A study led by the Yale School of Public Health found and “conducted at Yale New Haven Hospital with 44 inpatients and 98 health care workers—found that saliva samples taken from just inside the mouth provided greater detection sensitivity and consistency throughout the course of an infection than the broadly recommended nasopharyngeal (NP) approach. The study also concluded that there was less variability in results with the self-sample collection of saliva,” states a Yale University news release.

In, “Saliva Is More Sensitive for SARS-CoV-2 Detection in COVID-19 Patients than Nasopharyngeal Swabs,” published on the preprint server medRxiv, Yale researchers also noted a saliva test—as compared to a test using a nasal swab—is less invasive and more likely to be reliably self-administered. However, they remain cautious about jumping to saliva as a specimen versus nasal swabs.

Anne Wyllie, PhD
Anne Wyllie, PhD, Associate Research Scientist at Yale School of Public Health, told Time magazine, “Saliva itself is a newer diagnostic method, and a lot of people don’t know how to work with it, are scared to work with it, or not sure how to work with it. Just because a protocol is working with swabs doesn’t mean the same protocol will work with saliva.” Nevertheless, public demand for less invasive COVID-19 testing means clinical laboratories may soon be receiving more requests for processing saliva over nasal swabs. (Photo copyright: Yale University.)

Yale received FDA EUA for SalivaDirect, a real-time quantitative polymerase chain reaction (RT-qPCR) for detection of SARS-CoV-2. However, SalivaDirect is not an “at-home” test. It requires saliva samples to be self-collected into a sterile container in the presence of a healthcare professional, and is being provided by Yale to clinical laboratories as an “open source” protocol, the FDA said in a news release.

“We are trying to work with smaller local labs that want to get up and running to support schools, community groups, universities, and colleges,” Wyllie told Time.

In “Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2,” published in the New England Journal of Medicine (NEJM), Wyllie and others suggest saliva can be just as effective in detecting the coronavirus that causes COVID-19. In their study, COVID-19 patients who were tested by healthcare workers using nasopharyngeal swabs were then asked to collect their own saliva samples.

The researchers found that “Collection of saliva samples by patients themselves negates the need for direct interaction between healthcare workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial infection. Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of SARS-CoV-2 infection.”

The Yale scientists used primer sequences identified by the Centers for Disease Control and Prevention to detect the coronavirus. They found more SARS-CoV-2 RNA in saliva specimens than in the nasopharyngeal swab specimens. Also, 81% of saliva samples were positive one to five days after diagnosis, as compared to 71% of the nasopharyngeal swab specimens. 

“The findings suggest saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of SARS-CoV-2 during the course of hospitalization,” the researchers wrote in their NEJM paper.

The increasing popularity of at-home COVID-19 testing—along with studies showing that results improve when specimens are self-collected—suggest that medical laboratory managers should closely monitor the rise of COVID-19 home tests, as well as progress being made in saliva for diagnosing the SARS-CoV-2 coronavirus.

Further, it might be a smart strategy for clinical laboratories with the capability to perform this testing to approach retailers in their region and establish relationships where retailers sell the collection kits, and the lab performs the test and reports the results.

Since patients pay cash for the SARS-CoV-2 tests at the time they purchase the kits, clinical labs are guaranteed payment for the tests without the need to submit claims to consumers’ insurance companies. That’s another benefit to these types of arrangements.

—Donna Marie Pocius

Related Information:

Costco Sells At-Home COVID-19 Tests Using Saliva Samples

EUA for the P23 Labs TaqPath SARS-CoV—2 Assay

FDA Authorizes First Diagnostics Test Using Home Collection Saliva

There are 12 Coronavirus Tests You Can from Home: How They Work and How to Get One

Saliva Samples Preferable to Deep Nasal Swabs Testing for COVID-19

Saliva is More Sensitive for SARS-CoV-2 Detection in COVID-19 Patients Than Nasopharyngeal Swabs

FDA Issues Emergency Use Authorization Yale School of Public Health

COVID-19 Saliva Spit Test

Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2

Travel Restrictions Spur Four US Airlines to Get Into COVID-19 Testing, But Will Clinical Laboratories Get this Testing Business?

United Airlines creates pilot program for on-site rapid PCR tests, as other airlines facilitate at-home specimen collection for rapid coronavirus testing

Four US airlines attempting to recover lost business due to the COVID-19 pandemic are partnering with developers of rapid RT-PCR (reverse transcription polymerase chain reaction) tests to facilitate testing of passengers either at airports before they board their flights, at drive-through testing sites, or at-home in advance of scheduled travel.

This would be a great opportunity for clinical laboratories to gain business, but few details are known about how these airlines are selecting providers for the COVID-19 tests that will be part of their programs.

The deals come amid calls from the International Air Transport Association (IATA) “for the development and deployment of rapid, accurate, affordable, easy-to-operate, scalable and systematic COVID-19 testing for all passengers before departure as an alternative to quarantine measures” in many countries, states an IATA press release.

“The key to restoring the freedom of mobility across borders is systematic COVID-19 testing of all travelers before departure,” said Alexandre de Juniac, IATA Director General and CEO, in the IATA press release. “This will give governments the confidence to open their borders without complicated risk models that see constant changes in the rules imposed on travel.”

From a clinical laboratory testing perspective, the requirement for passengers to be tested prior to travel may contribute to two changes in the lab testing marketplace:

  • Consumers may become accustomed to buying home collection kits for COVID-19 and sending specimens to clinical laboratories. This could have the added benefit of helping consumers become comfortable doing this for other diagnostic tests as well.
  • Pursuit of profit from manufacturing COVID-19 tests that utilize consumer-collected specimens may increase competition in this market and would likely increase the number of at-home specimen collection products that are easier and more convenient to use.

US carriers offering the COVID-19 tests include United Airlines, American Airlines, Hawaiian Airlines, and JetBlue.

United Airlines

United is providing on-site testing through pilot programs at San Francisco International Airport (SFO) and Newark Liberty International Airport (EWR). At SFO, passengers are tested before taking flights to Hawaii. At EWR, they are tested prior to boarding a thrice-weekly flight to London Heathrow.

“We believe the ability to provide fast, same-day COVID-19 testing will play a vital role in safely reopening travel around the world and navigating quarantines and travel restrictions, particularly to key international destinations like London,” said Toby Enqvist, United’s Chief Customer Officer, in a press release.

United began offering testing at SFO on Oct. 15. According to “COVID-19 Testing for United Travelers,” the San Francisco to Hawaii passengers have two options:

  • A $105 drive-through test administered two or three days prior to flights by Color, a San Francisco Bay area health technology company.

The airline says a negative test ensures that travelers can bypass Hawaii’s mandatory quarantine requirements in Lihue, Maui, and Honolulu. For the Newark-to-London flights, United plans to run a pilot rapid testing program from Nov. 16 to Dec. 11. for passengers boarding Flight 14, departing at 7:15 p.m. Mondays, Wednesdays, and Fridays. Premise Health will administer the testing, which will be free to passengers. Those who choose not to be tested will be placed on other flights.

American Airlines testing passengers for COVID-19
A United Airlines flight attendant (above) receives an RT-PCR test for COVID-19 prior to boarding. If the flying public embraces preflight coronavirus testing, including at-home specimen collection kits, clinical laboratories may see a spike in requests for test processing. (Photo copyright: The Washington Post.)

American Airlines

American is offering COVID-19 testing for passengers scheduled on flights to Hawaii, Latin America, and the Caribbean, according to a press release. For the most part, these are at-home specimen collection RT-PCR tests provided by healthcare testing services company PrivaPath Diagnostics, Inc. (d.b.a., LetsGetChecked). Customers receive their results within 24 to 72 hours after the lab receives the samples.

On flights from Dallas Fort Worth International Airport to Hawaii and Costa Rica, passengers have the option of on-site rapid testing at the airport or in-person testing at CareNow urgent care facilities in North Texas.

As with the United flights to Hawaii, the testing program allows passengers to bypass quarantine requirements at their destinations. Customers pay $119 for the LetsGetChecked at-home specimen-collection kit and subsequent RT-PCR testing.

“Our initial preflight testing has performed remarkably well, including terrific customer feedback about the ease and availability of testing options,” American Airlines President Robert Isom said in the press release.

Hawaiian Airlines and JetBlue

In separate press releases, Hawaiian Airlines and JetBlue announced partnerships with Vault Health to offer at-home saliva tests to passengers. After receiving the at-home specimen collection kit, customers can connect through Zoom video conferencing with a Vault Health supervisor who ensures the sample is collected properly.

Hawaiian Airlines also offers drive-through testing at SFO and Los Angeles International Airport through a partnership with Worksite Labs. Passengers pay $90 to receive test results within 36 hours or $150 for express service on the day of travel. Worksite uses a Droplet Digital PCR shallow nasal swab test. The airline says it plans to expand this to other airports.

The Vault Health and Worksite Labs tests meet the state’s guidelines for exemption from the 14-day quarantine requirement, the airlines say.

Impact on Medical Laboratories

Airlines offering COVID-19 testing to their passengers may trigger both an opportunity and a change in the clinical laboratory testing marketplace. First, there is a business opportunity for labs to provide rapid molecular SARS-COV-2 tests to airlines.

Second, if consumers begin using at-home specimen collection kits in greater numbers as part of their air travel requirements, might this make them more comfortable doing self-collection for other types of clinical laboratory tests? A shift in consumer willingness to collect their own medical laboratory specimens—accompanied by ongoing innovations in diagnostic technologies, may eventually reduce the need for medical labs to operate extensive networks of patient service centers.

Of course, such a scenario is years away. But airline COVID-19 testing programs are just one of the progressive steps that can help make that possibility into a reality.

—Stephen Beale

Related Information:

These U.S. Airlines Are Offering Pre-Flight Covid-19 Testing—for a Price

United Airlines Launches World’s First Free Transatlantic COVID-19 Testing Pilot

American Airlines Takes First Steps to Open International Markets to Travel with Preflight COVID-19 Testing

American Airlines Adds Costa Rica to Preflight COVID-19 Testing Program

McKinsey and Company Says the COVID-19 Pandemic is Accelerating Six Critical Trends in Healthcare, at Least One Which Would Benefit Anatomic Pathologists

Clinical laboratory and pathology groups that support ambulatory and virtual care, and urgent care and retail clinics may experience growth

Global management consulting company McKinsey and Company’s report, “The Great Acceleration In Healthcare: Six Trends to Heed,” identifies six trends in healthcare that are accelerating due to the global COVID-19 pandemic.

Clinical laboratory managers and pathology practice administrators should consider how these trends may affect their business and patients when planning for the future.

The McKinsey graphic six trends that are likely to shape post-COVID-19 healthcare
The McKinsey graphic above illustrates the “six trends that are likely to shape post-COVID-19 healthcare.” Clinical laboratories that support health networks struggling with any of these challenges should take steps to prepare for anticipated changes to healthcare delivery. (Graphic copyright: McKinsey and Company.)

1: Healthcare Reform

McKinsey identified three areas where the coronavirus pandemic may impact healthcare reform:

  • “COVID-19-era waivers that could become permanent.
  • “Actions that may be taken to strengthen the healthcare system to deal with pandemics.
  • “Reforms to address the COVID-19-induced crisis.”

McKinsey reports that “the Centers for Medicare and Medicaid Services has introduced more than 190 waivers since the beginning of March 2020.” These waivers can affect all aspects of healthcare, from clinical practice to reimbursement. Some of them, according to McKinsey, are “only relevant during the crisis (for example, the waiver of intensive care unit death reporting). A retrospective assessment of others (for example, expansion of telehealth access) could reveal beneficial innovation worth preserving.”

Several areas that McKinsey says are clearly ripe for reform include improving the resiliency of the healthcare system and the way the system is funded.

Public sector budgets are generally kept strictly separate, each with its own rules and policies that dictate operations. But in his article, “After COVID-19—Thinking Differently About Running the Health Care System,” published in JAMA Health Network, Stuart M. Butler, PhD, Senior Fellow in Economic Studies at the Brookings Institution, wrote, “The intensity of the COVID-19 pandemic … is forcing jurisdictions all across the country to find ways to be nimble so that multiple agencies can work together.”

Thus, McKinsey recommends, “Given the substantial shifts in relative market positioning among industry players that prior reforms have created, leaders would do well to plan ahead now.”

2: Better Access to Healthcare Services

Some people who develop COVID-19 are at far greater risk of hospitalization and death than others, including those who have:

  • Chronic health conditions, including obesity.
  • Mental and behavioral health challenges, such as substance abuse.
  • Unmet social needs, such as food or housing insecurity.
  • Poor access to healthcare.

McKinsey wrote that these “intersecting health and social conditions,” combined with certain races that have higher risk for severe complications, including Black, Indian, and Hispanic/Latino Americans, “correlated with poorer health outcomes.”

Value-based healthcare, telehealth, and greater attention to the social determinants of health may help address some of these issues, McKinsey notes, but the pandemic has shined a spotlight on how lack of care increases risk for certain populations during a public health crisis.

3: Era of Exponential Improvement Unleashed

Some of the trends that appear to be accelerating as a result of the pandemic are good news. McKinsey cites several benefits, including:

  • Improved understanding of patients.
  • Delivery of more convenient and individualized care.
  • $350-$410 billion in annual revenue by 2025.

Through telehealth and other types of virtual care enabled by digital technology, “intuitive healthcare ecosystems” may arise and offer a more integrated experience for patients and their caregivers, McKinsey notes.

“While the pace of change in healthcare has lagged other industries in the past, potential for rapid improvement may accelerate due to COVID-19. An example is the exponential uptake of digitally enabled, virtual care,” McKinsey wrote. “Our analysis … showed that health systems, primary care, and behavioral health practices are reporting increases of more than 50–175 times in telehealth visits, and the potential market size for virtual care could reach around $250 billion.”

McKinsey and Co. report digital enabled virtual care graph
The graphic above is taken from the McKinsey and Co. report, which noted, “Proliferation of digitally enabled, virtual care could further contribute to the rise of personalized and intuitive healthcare ecosystems [that] have the potential to deliver an integrated experience to consumers, enhance productivity of providers, engage both formal and informal caregivers, and improve outcomes while lowering cost.” (Graphic copyright: McKinsey and Company.)

4: The Big Squeeze

The pandemic has caused an enormous outflow of cash from the healthcare system, and some experts don’t expect an injection of funding until 2022. “This outflow is expected to be primarily driven by coverage shifts out of employer-sponsored insurance and possible coverage reductions by employers as well as Medicaid rate pressures from states,” McKinsey states.

“We estimate that COVID-19 could depress healthcare industry earnings by between $35 billion and $75 billion compared with baseline expectations,” McKinsey predicted, adding, “Select high-growth segments will remain attractive (for example, virtual care, home health, software and platforms, specialty pharmacy) and will disproportionally drive growth. These high-growth areas are expected to increase more than 10% over the next five years, while other segments may stagnate or decline altogether.”

5: Fragmented, Integrated, Consolidated Care Delivery

McKinsey says, “The shift of care out of hospitals is not new but has been accelerated by COVID-19.” Rather than the hospital being the center of care delivery, patients are increasingly choosing to receive care at a range of sites across many healthcare ecosystems that are connected digitally and through analytics.

Early in the course of the pandemic, visits to ambulatory care facilities dropped nearly 60% by early April. But by mid-May, those visits were beginning to rebound.

In, “The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges,” the Commonwealth Fund reported that “the relative decline in visits remains largest among surgical and procedural specialties and pediatrics” but is “smaller in other specialties, such as adult primary care and behavioral health.”

virtual care and outpatient options show more potential revenue growth through 2022 graph
The McKinsey graphic above shows how “virtual care and outpatient options show more potential revenue growth through 2022.” Clinical laboratories that support those healthcare settings, especially ambulatory surgery, behavioral health, and retail clinics, should experience similar growth. (Graphic copyright: McKinsey and Company.)

6: Adoption of Next-Generation Managed Care Is Accelerating

How will COVID-19 affect the managed care industry? McKinsey says the “next generation” of managed care might use Medicare Advantage as a model.

“Payers pursuing the next generation of managed care model (through deep integration with care delivery) demonstrate better financial performance, capturing an additional 50 basis points of earnings before interest, taxes, depreciation, and amortization above expectation,” McKinsey noted, adding, “Employers and payers could consider fundamentally rethinking how employer-sponsored health coverage is structured. Learning from Medicare Advantage could provide inspiration for such a reimagination.”

What Should Clinical Laboratory Managers Do?

The McKinsey article concludes by stating, “While the challenges are numerous, leaders who seize the mindset that “disruptive change provides an opportunity to separate yourself from the pack” will build organizations meaningfully stronger than the ones they ran going into the crisis.”

The McKinsey article authors recommend that healthcare organizations take several proactive steps, including:

  • Launch a plan-ahead team.
  • Question your role and your future business model.
  • Prepare to transform your business.
  • Reimagine your organization to make faster decisions.
  • Take action to drive health equity.

Though the McKinsey and Company article covered healthcare in general, many of the authors’ observations and recommendations can apply to clinical laboratories and pathology groups as well and may be valuable in future planning.

—Dava Stewart

Related Information:

The Great Acceleration in Healthcare: 6 Trends to Heed:

After COVID-19—Thinking Differently About Running the Health Care System:

The Next Wave of Healthcare Innovation: The Evolution of Ecosystems

The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges

As Primary Care Providers and Health Insurers Embrace Telehealth, How Will Clinical Laboratories Provide Medical Lab Testing Services?

Repositioning the Clinical Laboratory as a Strategic Pillar of the Value-Based Healthcare Organization, Consistent with Clinical Lab 2.0

Panel of experts in healthcare and the clinical laboratory market identify key trends and discuss how innovative medical laboratories are adding value—and getting paid for that value

Effective clinical laboratory leadership in today’s value-based healthcare system means demonstrating value within an integrated delivery network. After all, as fee-for-service payment for clinical lab tests gives way to value-added reimbursement arrangements, all medical laboratories will need to justify their share of a value-based payment.

But how can clinical laboratories alert physicians and their parent hospitals to the real value they offer to improve patient outcomes and reduce healthcare costs? Though lab leaders may understand their medical lab’s complexity, accessibility, and impact, the question is how to direct the effort. The answer lies in a risk that some laboratory directors may not have considered.

Value-based healthcare systems include hospital-based medical laboratories as an essential part of their integrated health system. And, to lower the cost of care, healthcare systems involved in value-based care know they must become better at coordinating care and offering precision medicine services to their patients.

Year-by-year, more integrated health systems are learning how to eliminate gaps in care and become more proactive in delivering care that helps keep patients healthy. However, the task of leveraging the clinical laboratory in a strategic approach to demonstrating value in those health systems remains daunting. One of the goals of the Clinical Lab 2.0 model developed by the Project Santa Fe Foundation clinical laboratory organization is to demonstrate how labs can achieve two goals:

  • Create added-value services that improve patient care; and
  • Have health insurers, accountable care organizations (ACOs), and health networks pay remuneration to the clinical labs for those added-value services.

Pathologists, Clinical Chemists, and MTs Leave Thy Medical Labs

Expert panelists of a recent webinar hosted by Dark Daily and sponsored by Sunquest Information Systems suggested ways that clinical laboratories could better position themselves to be an asset for their organizations. One way to do this is to get their clinical pathologists, PhDs, and medical technologists out of the lab and engaged with physicians, nurses, and other clinical staff in specific ways that influence the healthcare organization’s overall performance in delivering better patient outcomes at less cost.

“If your pathologists aren’t sitting on the medical informatics committee or the clinical quality-improvement committee or any one of the myriad things at the enterprise level, that’s going to be a risk for you,” said Michael J. Crossey, MD, PhD, CEO and Chief Medical Officer for TriCore Reference Laboratories, during the webinar “Listen, Learn, Lead: Uncover Ways You Can Position Your Lab as a Strategic Pillar of the Healthcare Organization.” 

“Our labs have to be equal partners instead of recipients of where things are going,” he stressed. “We need to be, if not in the driver’s seat, at least in the front seat.”

The expert webinar panelists included:

Mark Dixon (above), President of the Mark Dixon Group LLC, moderated the webinar, which was sponsored by Sunquest Information Systems  and The Dark Report, sister publication of Dark Daily. Dixon has more than 30-years’ experience as a health system CEO and COO. He said TriCore and other labs are succeeding at value-based healthcare using methods that are well-defined and available for all clinical laboratories to learn. For example: TriCore has found that certain health insurers are willing to not only pay their laboratory differently, but also meet with the lab’s pathologists and leaders to negotiate value-based care arrangements. (Photo copyright: Mark Dixon Group.)

Fundamental Changes That Will Impact All Clinical Laboratories

The panel speakers discussed how clinical laboratories can strategically position themselves to be successful in today’s evolving healthcare industry. They predicted several fundamental changes would take place or continue. These changes include:

  • A continued shift away from pure fee-for-service payment (volume) to value-based reimbursement that rewards improved patient outcomes;
  • More discussion regarding prevention of illnesses, chronic diseases, and personal responsibility;
  • More focus on primary care and proactive care;
  • Rapid advances in science and technology that will spark development of new healthcare applications;
  • Continued trend toward consumerism, as more patients pay a larger portion of their healthcare expenses and shop for hospitals, doctors, and labs; and
  • Intense cost pressure on healthcare organizations and their medical laboratories.

It was noted during the panel discussion that, even as the US spends more than any other country in the world on healthcare, it has some of the worst overall outcomes.

Customers Rapidly Becoming Stakeholders

“I always think in terms of stakeholders and the number one stakeholder for any clinical laboratory or healthcare system is always the customer,” said Peters. “The lab’s customer is the ordering physician. So, it’s important that labs ‘speak their language’ and understand that the physician’s customer is the patient.”

Clinical laboratories also must be aware of what a particular healthcare system is trying to accomplish. “Lab leaders should stay in constant touch with where the market is, where the system is, and where reform is,” said Oravetz. “And realize there are things that can be done today to set up for what’s coming tomorrow.”

Terese said that for a clinical laboratory to survive during this rapid transformation of the US healthcare system—or at least continue to thrive—it needs to engage with the strategic and clinical initiatives guiding every health system around the country. “There is tremendous opportunity for clinical laboratories to not only support that transition, but to actually help drive it,” he said. “There’s nothing wrong with thinking of your medical laboratory as a leader of these initiatives, versus just as a follower of what the organization is doing.”

Key elements of the webinar that will be of interest to clinical laboratories include:

  • Examples of clinical laboratories navigating the transition from volume to value-based care;
  • Discussion and update on fundamental changes coming to the US healthcare industry that impact clinical laboratories;
  • The case for demonstrating the value of clinical labs to healthcare organizations; and
  • Eight ways to elevate the value of clinical labs within an integrated healthcare network.

The experts on this special discussion panel agree that US healthcare and the clinical laboratory marketplace is in a time of transition. Pathologists and medical laboratory scientists have an opportunity to position themselves as leaders and changemakers to the benefit of patients, as well as their parent hospitals and health networks.

This free webinar can be a critical tool for leadership training within every clinical laboratory. It can be used to give lab managers and lab staff fresh insights into the changes happening in healthcare. Insights that can guide strategic planning and inspire laboratory-led projects to collaborate with physicians and improve patient care.

Download this webinar for free by clicking here. (Or, copy and paste this URL into your browser: https://darkintelligenceprogramsondemand.uscreen.io/programs/listen-learn-lead-uncover-ways-you-can-position-your-lab-as-a-strategic-pillar-of-the-healthcare-organization.)

—JP Schlingman

Related Information:

Free On-Demand Webinar: Listen, Learn, Lead: Uncover Ways You Can Position Your Lab as a Strategic Pillar of the Healthcare Organization

Ochsner Accountable Care Network Recognized Nationally for Quality and Efficiency

Defining Value—The Foundation of Outcomes-Based Risk-Sharing Agreements

Value-Based Contracts with Risk 3 to 5 Years Away for Providers

Humana’s New Oncology Value-Based Care Program Includes Quality and Cost Measurements of Provider Performance, Clinical Laboratories, and Pathology Groups

UC Davis Researchers Develop Microscope That Uses Ultraviolet Light for Diagnosis, Eliminates Need for Traditional Histology Slide Preparation

MUSE microscope speeds up some anatomic pathology laboratory processes and removes exposure to toxic fixative chemicals

Because they handle tissue specimens, histotechnologists, anatomic pathologists, and hospital nurses are exposed to deadly chemicals such as formaldehyde, formalin, Xylene, and Toluene. The risks associated with these chemicals has been covered regularly by Dark Daily as recently as 2018 and as far back as 2011. (See, “Europe Implements New Anatomic Pathology Guidelines to Reduce Nurse Exposure to Formaldehyde and Other Toxic Histology Chemicals,” January 3, 2018; and, “Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene,” July 5, 2011.)

Now, scientists at the University of California at Davis (UC Davis) have developed a microscope that uses ultraviolet light (UV) to illuminate tissue samples. The UV microscope removes the need for traditional histology processes involved with preparation of tissue to produce conventional slides and makes it possible for anatomic pathologists to evaluate tissues without formalin fixation, according to a UC Davis news release.

“Here, we introduce a simple, non-destructive slide-free technique that, within minutes, provides high-resolution diagnostic histological images resembling those obtained from conventional hematoxylin and eosin histology,” the researchers wrote in their paper, published in Nature Biomedical Engineering.

High-resolution Biopsy Images in Minutes

The UV microscope relies on technology that UC Davis researchers dubbed MUSE, which stands for Microscopy with Ultraviolet Surface Excitation. According to the researchers, MUSE produces high-resolution images of biopsies and other fresh tissue samples that are ready for a pathologist’s review within minutes.

“MUSE eliminates any need for conventional tissue processing with formalin fixation, paraffin embedding, or thin-sectioning. It doesn’t require lasers, confocal, multiphoton, or optical coherence tomography instrumentation. And the simple technology makes it well-suited for deployment wherever biopsies are obtained and evaluated,” stated Richard Levenson, MD, MUSE Microscopy CEO, Professor, and Vice Chair for Strategic Technologies in the Department of Pathology and Laboratory Medicine at UC Davis, in the news release.

Ultraviolet microscopy is distinguished by its ability to magnify samples and enable views with greater resolution. This is due to the shorter wavelength of ultraviolet light, which improves image resolution beyond the diffraction limit of optical microscopes using normal white light, according to News Medical.

The unique ultraviolet light microscope tool may soon enable clinical laboratories and anatomic pathology groups to accurately report on biopsies to physicians and patients faster, for less money, and without exposure to deadly chemicals. This would be timely considering the pressure on the pathology industry to switch to value-based reimbursement from fee-for-service billing, and to embrace personalized medicine.

Richard Levenson MUSE UC Davis

“It has become increasingly important to submit relevant portion of often tiny tissue samples for DNA and other molecular functional tests,” notes Richard Levenson, MD, MUSE Microscopy CEO, Professor, and Vice Chair for Strategic Technologies in the Department of Pathology and Laboratory Medicine at UC Davis, shown above with MUSE. “Making sure that the submitted material actually contains tumor in sufficient quantity is not always easy and sometimes just preparing conventional microscope slices can consume most of or even all of small specimens. MUSE is important because it quickly provides images from fresh tissue without exhausting the sample.” (Photo and caption copyright: UC Davis.)

MUSE is being commercialized and investors sought by MUSE Microscopy, Inc.

Traditional Microscopy is Time-Consuming, Hazardous, Expensive

Light microscopy, a time-honored technology, has been available to pathologists for more than 200 years. It is the cornerstone for cancer diagnostics and pathology, the UC Davis researchers acknowledged. But it requires time-consuming and expensive processes, which are especially glaring in a resource-challenged healthcare industry, they pointed out.

“Histological examination of tissues is central to the diagnosis and management of neoplasms and many other diseases. However, commonly used bright-field microscopy requires prior preparation of micrometer-thick tissue sections mounted on glass slides—a process that can require hours or days, contributes to cost, and delays access to critical information,” they wrote in their paper.

“MUSE promises to improve the speed and efficiency of patient care in both state-of-the art and low-resource settings, and to provide opportunities for rapid histology in research,” they continued.

No Histology Slide Preparation Needed

MUSE developers also called attention to the use of hazardous chemicals, such as formalin, in lab processes, which has been linked to cancers including myeloid leukemia, nasopharyngeal cancer, and sinonasal cancer, according to a National Academy of Sciences report. Still, more than 300 million slides are prepared in the US each year at a cost of several billion dollars to the healthcare industry, according to the MUSE Website.

MUSE, however, penetrates tissue samples by using ultraviolet light at short wavelengths—below the 300-nanometer range. The MUSE ultraviolet microscope can reach several microns-deep into tissues.

That’s enough, the researchers claim, to be comparable with the thickness of tissue slices anatomic pathologists use with traditional microscope slides. However, MUSE requires no conventional tissue processing associated with histology slides.

How Does it Work?

MUSE is comprised of an optical system with UV light-emitting diodes (LEDs), a UV compatible stage, and a conventional microscope. That’s according to Photonics Online, which described the process:

  • “UV light at 280 nanometer spectral range illuminates about one square millimeter of specimen;
  • “Surface is limited to a few nanometers deep to make high-contrast images possible;
  • “Excitation light, at sub-300 nanometer spectral region, elicits bright emission from tissue specimens;
  • “Specimens, which were stained with conventional florescent dyes, emit photons;
  • “Photons are captured using glass-based microscope optics;
  • “A Python programing language solution, with a graphics unit, converts MUSE images in real-time;
  • “Images are comparable to the hematoxylin and eosin versions histologists and pathologists are accustomed to.”

The result, according the MUSE website, “is stunning detailed images conveying a degree of resolution, structure, and depth unachievable until now by any single technology.”

Other Alternative Histology Processes Under the Microscope

MUSE is not the only approach being studied that could create cellular images without sectioning tissue samples. Anatomic and histopathology laboratory leaders looking to differentiate their labs should keep watch on the development of MUSE and other alternatives to current histology methods, especially once these new devices become green-lighted by the Food and Drug Administration (FDA) for use in patient care.

—Donna Marie Pocius

Related Information:

Microscope That Uses Ultraviolet Instead of Visible Light Emerging as Powerful Diagnostic Tool

Microscope with Ultraviolet Surface Excitation for Rapid Slide-Free Histology

Ultraviolet Microscope to Dramatically Speed-up Lab Tests

What is Ultraviolet Microscopy?

Europe Implements New Anatomic Pathology Guidelines to Reduce Nurse Exposure to Formaldehyde and Other Toxic Histology Chemicals

National Academy of Sciences Confirms That Formaldehyde Can Cause Cancer in a Finding That Has Implications for Anatomic Pathology and Histology Laboratories

Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene

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