Keynote Speakers at the Executive War College Describe the Divergent Paths of Clinical Laboratory Testing as New Players Offer Point-of-Care Tests and More Consumers Want Access to Home Tests
27th annual meeting of medical laboratory and pathology managers delivers insights on the path ahead for diagnostics, ranging from the supply chain shortage and the ‘Great Resignation’ to advances in artificial intelligence and whole genome sequencing in service of precision medicine
Divergent paths of diagnostic testing are among the central topics being discussed at the 27th annual Executive War College on Laboratory and Pathology Management happening this week in New Orleans.
What’s coming as healthcare providers move to post-COVID-19 pandemic workflows will be of keen interest to clinical laboratory leaders attending this critical event. Several new and dynamic market changes are reshaping the development of, ordering, and reimbursement for medical laboratory tests. They include:
- Millennials as change agents in how care is accessed and delivered.
- New buyers of large volumes of clinical lab tests, such as retail pharmacies.
- How clinical laboratories can earn new sources of revenue while supporting precision medicine.
Clinical Labs Should Prepare for the ‘Coming Roller Coaster Ride’
Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication, The Dark Report, and Founder of the Executive War College, described the “coming roller coaster ride” for the pathology and clinical laboratory industries.
Amid the usual operational issues labs deal with (e.g., workforce shortages, supply chain disruptions, regulatory pressures), he noted the emergence of new and powerful forces pulling clinical laboratories and pathology groups in all directions.
“One primary factor is how Millennials will use healthcare differently than Gen Xers and Baby Boomers,” Michel noted. “Similarly, Millennials will make up 75% of the pathologists and the lab workforce by 2025.
“Another major force for change will be new buyers of clinical laboratory tests,” he continued. “For example, expect to see national retail pharmacy chains build thousands of primary care clinics in their retail pharmacies. These clinics will need lab tests and will become major buyers of near-patient analyzers and lab tests.
“A third interesting factor is that a new class of in vitro diagnostics (IVD) manufacturers are developing analyzers and test systems that use minimal amounts of specimens and return answers in minutes. Primary care clinics in retail pharmacies will be interested in buying these lab testing solutions,” Michel concluded.
Peer-to-Peer Learning Opportunities
With approximately 90 presenters scheduled, clinical laboratory leaders from such prestigious institutions as Johns Hopkins Hospital, Mayo Clinic, United Indian Health Services, and more will facilitate peer-to-peer learnings throughout the conference.
In addition, industry executives scheduled to deliver keynotes include Jon Harol, Lighthouse Lab Services Founder and President; Stan Letovsky, PhD, Vice President for AI, Data Sciences and Bioinformatics as well as other executives from Labcorp; and Curtiss McNair II, Vice President and General Manager of Laboratory Services at American Oncology Network.
In addition, several sessions and panel Q/A discussions will cover critical legal and regulatory issues and payer challenges facing the industry.
New Technologies, Workflows, Analytics
The 2022 Executive War College master classes, breakouts, panel discussions, and benefactor sessions will highlight several significant themes:
- Lab data analytics and utilization. Sessions this year are heavily weighted toward data analytics, aggregation, and utilization. Look for case studies demonstrating the value of lab data, and where and how data has become actionable and monetized. As Dark Daily previously reported, useful data structures have been difficult to achieve for clinical laboratories; however, the case studies featured during this week’s conference will demonstrate signs of progress and highlight lessons learned.
- Automation. Several case studies are planned that focus on expansion and modernization using laboratory automation. From Butler Health System, an independent hospital system in western Pa., Robert Patterson, MD, Medical Director of Pathology, Laboratory Medicine, and Laboratory Outreach, will detail steps Butler took that enabled its labs to better compete with other area health systems and national reference laboratories. Likewise, Eric Parnell, System Supervisor of Microbiology for Bronson Healthcare in southern Mich., will discuss his lab’s transition to and implementation of total laboratory automation.
- Genetic testing and next-generation sequencing (NGS). Quickly becoming the foundational disruptor technology on which many new and powerful clinical laboratory tests and procedures are based, genomic testing has now become accessible and affordable. Many clinical laboratories and pathology groups are using molecular diagnostics testing to deliver clinical value to referring physicians.
Other sessions include:
- Launching and scaling clinical NGS testing in a clinical environment (featuring a project at Rady Children’s Hospital in San Diego).
- How labs and payers can work together to achieve better outcomes and health equity using genomic testing.
- Effective ways to repurpose PCR and other genetic test instruments to build specimen volume and increase lab revenue.
Paths Forward for Clinical Labs and Pathology Groups
Another important topic being discussed at the 2022 Executive War College is how to position clinical laboratories and pathology groups for the next phase of modern healthcare.
Legal experts and consultants from McDonald Hopkins LLC, Advanced Strategic Partners, Pathology Practice Advisors, and ECG Management Consultants, among others, will answer questions on:
- Attracting capital for clinical labs and pathology groups.
- Emerging concepts in growth strategies.
- Business valuation factors.
- Unexpected disruptions during sales closings.
These are just a few highlights of the informative sessions and expert speakers scheduled during this week’s 27th annual Executive War College in New Orleans. Look for more coverage in Dark Daily during the days ahead and in upcoming editions of our sister publication The Dark Report.
Full details about the 2022 Executive War College can be found by clicking on this link. (Or copy/paste this URL into your web browser: http://www.executivewarcollege.com.)
Speakers, session topics, and the conference agenda can be viewed by clicking on this link. (Or copy/paste this URL into your web browser: https://executivewarcollege.darkintelligencegroup.com/executive-war-college-agenda-2022.)
—Liz Carey
Related Information:
Retail Chain Pharmacies Add CLIA-Waived Point-of-Care Blood Testing and Other Preventive Health Services to Their In-store Offerings
Independent clinical laboratories may continue to see their customer numbers drop as more consumers choose healthcare delivered in non-traditional locations
More clinical laboratory companies are offering testing in non-traditional locations with non-traditional delivery systems to serve busy healthcare consumers and ambulatory patients. One such company is eTrueNorth, a pharmacy‐based clinical laboratory services network.
The Mansfield, Texas-based company has partnered with Walmart (NYSE:WMT), Winn-Dixie, Kroger (NYSE:KR), and other retailers to offer their employees CLIA-waived point-of-care testing, preventive health services, wellness screenings, and other medical laboratory testing services through its eLabNetwork chain of retail pharmacies.
This is yet another example of a company responding to the public’s demand for convenient healthcare delivery, including clinical laboratory testing.
Pharmacists as Care Givers
eTrueNorth has quietly built a 5,500-location network of independent CLIA-waived laboratories in retail pharmacies. By bringing point-of-care testing to community pharmacies, the company says it can close gaps in healthcare.
“By empowering local pharmacists to administer preventative healthcare screenings and close gaps in care, eTrueNorth is working in partnership with retail pharmacies, self-funded employers, third-party payors and pharmaceutical manufacturers to identify undiagnosed conditions and better manage chronic diseases,” the company’s website states. “By leveraging the accessibility of retail pharmacies, eTrueNorth expands the scope of services provided to consumers to be more effective, of higher quality and, at the same time, enhance the pharmacy’s value as a key participant in a multidisciplinary healthcare delivery model.”
The website states that eTrueNorth’s ePOCT software suite “simplifies administrative processes for CLIA-waived labs that conduct point-of-care testing.” It provides the infrastructure for CLIA-waived laboratories to meet all applicable federal, state, and local regulations. In addition, the company provides documentation to medical professionals as they track compliance with quality-control efforts for diagnostic devices.
In an exclusive interview with Dark Daily, Coral May, eTrueNorth’s CEO, President, and co-founder, said the company’s growth will continue to accelerate.
“In the next few months, we will be adding quite a few more [eLabNetwork locations] because we will be bringing on a couple of other major brands,” May said in a telephone interview.
May explained that all eLabNetwork pharmacies have standing orders for their limited test menu. This means consumers do not need a physician’s order to receive clinical laboratory services. As a result, however, consumers currently cannot submit a claim for the eLabNetwork service to their insurer. This is about to change.
Health Plans May Soon Partner with eLabNetwork Pharmacies
May announced that in the second quarter of 2020 eTrueNorth will launch “within several different health plans” the ability “to provide and submit claims for tests that will close quality measures, gaps in care.”
Though May could not yet announce which health plans will be partnering with eTrueNorth, she stated that participating insurers would be communicating with their members directly to steer them to eLabNetwork pharmacies where they can receive CLIA-waived testing.
May previously pointed out that health plans benefit from eTrueNorth engaging plan members at the pharmacy counter and addressing gaps in care ranging from diabetes testing to hypertension control and medication adherence. She cited as example an insurance plan member with diabetes who has not yet had an A1C test for diabetes or needs an microalbumin [urine] test.
“Our goal is to make it easier for individuals to have affordable and increased access to additional healthcare from the convenience of their local pharmacy,” she stated in a news release.
Another of eTrueNorth’s stated objectives is to increase the number of participants in the Center for Disease Control and Prevention (CDC) National Diabetes Prevention Program (National DPP), which was created in 2010 to increase evidence-based, cost-effective interventions that help prevent Type 2 diabetes.
In order for Medicare Advantage-eligible patients to participate in the program, they must have a fasting blood glucose test. eTrueNorth believes increasing access to point-of-care blood testing could boost participation in the DPP.
“The eTrueNorth Voucher Solution is designed to maximize participation in wellness-screening events by providing convenient access to screenings,” May said in a news release. “Local pharmacists are trusted medical providers to the community. The eTrueNorth Voucher Solution allows individuals to obtain the same high-quality, accurate testing at retail pharmacies as they would from their primary-care office.”
How the Voucher Solution Works
The company’s voucher program enables employees who miss onsite wellness screenings, or who work remotely, to visit a local pharmacy to obtain point-of-care testing and on-the-spot counseling.
Through eLabNetwork’s website, an employee can confirm eligibility, choose a pharmacy based on zip code, schedule an appointment and create a voucher. In addition, the eLabNetwork transmits results to the wellness plan and/or patient’s physician, invoices wellness plan vendors, and sends payments to participating pharmacies for:
- Full lipid panel;
- Glucose;
- Hemoglobin A1C testing (for individuals already diagnosed with diabetes); and
- Common vaccines.
The company has experienced rapid expansion, most recently adding the Kroger Family of Companies, Giant Food Stores, Food Lion, and Stop and Shop to its growing list of retail partners, a 2019 eTrueNorth Sell Sheet states.
“With 95% of the US population living within five miles of a retail pharmacy, eTrueNorth envisions a future where consumers can access healthcare,” May said in a company statement. “This expanding list of retail pharmacies has the potential to make a significant impact on how healthcare is delivered.”
Will independent clinical laboratories be affected by these events? Almost certainly. Dark Daily has reported often on the public’s increasing demand to receive healthcare in convenient, nearby locations, such as shopping malls and retail pharmacies. This is just another example of that expanding trend.
Lab leaders will want to keep a close eye on it and plan accordingly. It’s a trend that could potentially threaten clinical laboratories’ bottom lines.
—Andrea Downing Peck
Related Information:
eTrueNorth Creates Retail Pharmacy Network of CLIA-Waived Laboratories for Point-of-Care Testing
eTrueNorth Launches National Voucher Solution Enabling Wellness Screenings at Retail Pharmacies
eTrueNorth: Fitting Wellness into Everyday Life
Americans Are Using Convenient Care Clinics in Retail Settings
Singapore University Researchers Unveil Portable $1 Point-of-Care Testing That Speedily Tests for Multiple Diseases
Hand-held tests developed from the work of the NUS BIGHEART team could help caregivers in remote areas diagnose disease quickly, accurately, and inexpensively There is great demand in Asia for diagnostic tests that are cheap, accurate, and have a fast time to answer. Especially in Asia’s remote and mobile clinics where caregivers need immediate access to clinical laboratory test results at the time of patients’ visits. Researchers at the National University of Singapore (NUS) have unveiled...Lab-on-a-Fiber Technology Continues to Highlight Nano-Scale Clinical Laboratory Diagnostic Testing in Point-of-Care Environments
Ever shrinking “lab-on-a-…” technologies, a boon to medical laboratories and anatomic pathologists in remote resource-strapped regions, also have a place in modern labs
Researchers took another leap forward in reducing the size of clinical laboratory diagnostic tests and observational tools. This demonstration involved lab-on-a-fiber technology and showed promise in both monitoring anatomic pathology biomarkers in vivo and supplementing the abilities of existing lab-on-a-chip and microfluidic devices.
Lab-on-a-Fiber Next Technological Step Toward Miniaturization
In 2013, Dark Daily reported on research into an implantable laboratory-on-a-chip (LOC) for monitoring blood chemistry during chemotherapy. It was a major breakthrough at the time, which promised new and powerful tools for cancer treatment regimens.
However, most LOC systems aren’t designed for wet environments. Also, while microfluidics and flexible membranes allow for smaller footprints and tighter placement, they are still invasive in ways that might make patients uncomfortable or make real-world use less than ideal. And, long-term use brings further complications, such as corrosion or foreign-body granulomas.
Thus, lab-on-a-fiber’s ability to function in vivo, is one of the device’s principal advantages, as ExtremeTech noted.
Lab-on-a-fiber technology addresses many concerns. It is small enough to insert directly into organs, muscle mass, or veins when used as biosensors. And the fibers can return a wealth of information by using light and reflection, while allowing for minimal discomfort and precision placement.
Schematic of the lab-on-a-fiber biosensing principle. A metallic nanostructure supporting a resonant plasmonic mode is integrated on the optical fiber tip. When a molecular binding event occurs at the sensor surface, the reflectance peak associated to the plasmonic mode shifts towards longer wavelengths. (Image and caption copyright: Analyst/The Royal Society of Chemistry.)
The Past and Future of Scaling Clinical Laboratory Testing
Dark Daily has followed these miniaturization trends for years starting with their earliest stages. A detailed timeline of developments can be viewed in “Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?” from 2016.
Additional Dark Daily “lab-on-a-…” coverage includes:
- IBM Watson Health and Mount Sinai Health System team up to use LOC solutions to separate biomolecules as small as 20nm from samples (See Dark Daily, “IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution,” October 3, 2016); and,
- Lab-on-Skin devices for monitoring biomarkers and electrophysiological signals, providing human-machine interfaces, and facilitating optogenetics (See Dark Daily, “In the Field of Nano-Scale Diagnostics, Many Researchers Are Developing ‘Lab-on-Skin’ Technologies That Can Monitor Many Clinical Laboratory Biomarkers,” January 15, 2015).
In the past year, a myriad of lab-on-a-fiber applications also have received media coverage, including:
- Monitoring living organs and detecting biomarkers (see IEEE Spectrum, “How We’re Shrinking Chemical Labs Onto Optical Fibers”);
- High-sensitivity, rapid detection of tumors and cancer cells during brain surgery (see CTV News, “Fiber-Optic Device Can Detect Stray Cancer Cells and Improve Tumor Removal: Study”); and,
- Diagnosis and monitoring of muscle disorders (see New Atlas, “Fiber Optic Probe Beats a Biopsy for Measuring Muscle Health”).
Developers believe lab-on-a-fiber approaches could offer further adaptability and functionality to other “lab-on-a-…” technologies. For example, as highlighted in Advanced Science News, researchers are employing lab-on-a-fiber technologies to further refine and improve LOC functions and designs.
“As the scientific world moves inexorably to smaller dimensions … The emerging concept of ‘lab‐on‐fiber’ will give the optical fiber platform additional (highly integrated) functionalities,” noted Deepak Uttamchandani, PhD, Vice Dean Research, Faculty of Engineering, and, Robert Blue, PhD, Research Fellow, both at the University of Strathclyde, Glasgow, UK, in their review paper, “Recent Advances In Optical Fiber Devices for Microfluidics Integration.” The paper, published in the Journal of Biophotonics, examined “the recent emergence of miniaturized optical fiber-based sensing and actuating devices that have been successfully integrated into fluidic microchannels that are part of microfluidic and lab‐on‐chip systems.”
In his review paper on the emerging concept of lab-on-a-fiber, Deepak Uttamchandani, PhD, notes, “The versatility of the optical fiber platform has already allowed researchers to conduct immunoassays in microchannels using both fluorescently‐labelled and label‐free formats whilst gaining advantages of reduced assay time and increased sensitivity.” (Photo copyright: University of Strathclyde.)
Lab-on-a-Fiber: Another Step Forward or a Major Change?
At each milestone in the scaling of clinical laboratory testing, experts and media outlets predicted the demise of big laboratories and the dawn of a POC-centric testing era. Yet, despite 20-plus years of progress, this has yet to happen.
While it is critical for anatomical pathology leaders and clinical laboratory managers to stay abreast of developments in testing technology, much of the innovation behind lab-on-a-fiber remains strictly in the research realm. Challenges to the commercialization of these new techniques include both physical factors, such as design and manufacture of ready-to-use tests, and regulatory concerns, including FDA clearances and payer approval of new assays and diagnostic procedures.
Until researchers and test manufacturers overcome these hurdles, threats to current standards and workflows are minimal. However, much like the gains in scale realized through incorporating lab-on-a-chip concepts into clinical laboratory testing, the research powering these innovations might prove useful in further improving and expanding medical laboratory testing options.
—Jon Stone
Related Information:
Recent Advances in Optical Fiber Devices for Microfluidics Integration
Lab-on-Fiber Technology: A New Vision for Chemical and Biological Sensing [Abstract]
Lab-on-Fiber Technology: A New Vision for Chemical and Biological Sensing [Full Downloadable PDF]
How We’re Shrinking Chemical Labs onto Optical Fibers
Lab-on-Fiber Could Shine Light on Disease
Doctors Might Soon Diagnose You by Feeding a Lab-on-a-Fiber Straight into Your Veins
Fiber-Optic Device Can Detect Stray Cancer Cells and Improve Tumor Removal: Study
Fiber Optic Probe Beats a Biopsy for Measuring Muscle Health
Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?
Hematology on a Chip: University of Southampton Develops POC Blood Analysis
Whole Animal Assays Use Lab-on-a-Chip at MIT
IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution
