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New CRISPR Gene-editing Approach Under Development at Broad Institute Could Lead to Improved Clinical Laboratory Diagnostics for Genetic Diseases

‘Prime editing’ is what researchers are calling the proof-of-concept research that promises improved diagnostics and more effective treatments for patients with genetic defects

What if it were possible to edit genetic code and literally remove a person’s risk for specific chronic diseases? Such a personalized approach to treating at-risk patients would alter all of healthcare and is at the core of precision medicine goals. Well, thanks to researchers at the Broad Institute of MIT and Harvard, clinical laboratory diagnostics based on precise gene-editing techniques may be closer than ever.

Known as Prime Editing, the scientists developed this technique as a more accurate way to edit Deoxyribonucleic acid (DNA). In a paper published in Nature, the authors claim prime editing has the potential to correct up to 89% of disease-causing genetic variations. They also claim prime editing is more powerful, precise, and flexible than CRISPR.

The research paper describes prime editing as a “versatile and precise genome editing method that directly writes new genetic information into a specified DNA site using a catalytically impaired Cas9 endonuclease fused to an engineered reverse transcriptase, programmed with a prime editing guide RNA (pegRNA) that both specifies the target site and encodes the desired edit.”

And a Harvard Gazette article states, “Prime editing differs from previous genome-editing systems in that it uses RNA to direct the insertion of new DNA sequences in human cells.”

Assuming further research and clinical studies confirm the viability of this technology, clinical laboratories would have a new diagnostic service line that could become a significant proportion of a lab’s specimen volume and test mix.

Multiple Breakthroughs in Gene Editing

In 2015, Dark Daily reported on a breakthrough in gene editing by David Liu, PhD, Director of the Merkin Institute of Transformative Technologies in Healthcare at the Broad Institute, and his team at Harvard.

In that e-briefing we wrote that Liu “has led a team of scientists in the development of a gene-editing protein delivery system that uses cationic lipids and works on animal and human cells. The new delivery method is as effective as protein delivery via DNA and has significantly higher specificity. If developed, this technology could open the door to routine use of genome analysis, worked up by the clinical laboratory, as one element in therapeutic decision-making.”

Now, Liu has taken that development even further.

“A major aspiration in the molecular life sciences is the ability to precisely make any change to the genome in any location. We think prime editing brings us closer to that goal,” David Liu, PhD (above), Director of the Merkin Institute of Transformative Technologies in Healthcare at the Broad Institute, told The Harvard Gazette. “We’re not aware of another editing technology in mammalian cells that offers this level of versatility and precision with so few byproducts.”  (Photo copyright: Broad Institute.)

Cell Division Not Necessary

CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats. It is considered the most advanced gene editing technology available. However, it has one drawback not found in Prime Editing—CRISPR relies on a cell’s ability to divide to generate desired alterations in DNA—prime editing does not.

This means prime editing could be used to repair genetic mutations in cells that do not always divide, such as cells in the human nervous system. Another advantage of prime editing is that it does not cut both strands of the DNA double helix. This lowers the risk of making unintended, potentially dangerous changes to a patient’s DNA.  

The researchers claim prime editing can eradicate long lengths of disease-causing DNA and insert curative DNA to repair dangerous mutations. These feats, they say, can be accomplished without triggering genome responses introduced by other forms of CRISPR that may be potentially harmful. 

“Prime editors are more like word processors capable of searching for targeted DNA sequences and precisely replacing them with edited DNA strands,” Liu told NPR.

The scientists involved in the study have used prime editing to perform over 175 edits in human cells. In the test lab, they have succeeded in repairing genetic mutations that cause both Sickle Cell Anemia (SCA) and Tay-Sachs disease, NPR reported.

“Prime editing is really a step—and potentially a significant step—towards this long-term aspiration of the field in which we are trying to be able to make just about any kind of DNA change that anyone wants at just about any site in the human genome,” Liu told News Medical.

Additional Research Required, but Results are Promising

Prime editing is very new and warrants further investigation. The researchers plan to continue their work on the technology by performing additional testing and exploring delivery mechanisms that could lead to human therapeutic applications. 

“Prime editing should be tested and optimized in as many cell types as researchers are interested in editing. Our initial study showed prime editing in four human cancer cell lines, as well as in post-mitotic primary mouse cortical neurons,” Liu told STAT. “The efficiency of prime editing varied quite a bit across these cell types, so illuminating the cell-type and cell-state determinants of prime editing outcomes is one focus of our current efforts.”

Although further research and clinical studies are needed to confirm the viability of prime editing, clinical laboratories could benefit from this technology. It’s worth watching.

—JP Schlingman

Related Information:

Scientists Create New, More Powerful Technique to Edit Genes

Search-and-replace Genome Editing without Double-strand Breaks or Donor DNA

New CRISPR Genome “Prime Editing” System

Genome Editing with Precision

You had Questions for David Liu about CRISPR, Prime Editing, and Advice to Young Scientists. He has Answers

A Prime Time for Genome Editing

Prime Editing with pegRNA: A Novel and Precise CRISPR Genome Editing System

Prime Editing: Adding Precision and Flexibility to CRISPR Editing

Gene-Editing Advance Puts More Gene-Based Cures Within Reach

Harvard, MIT Researchers Develop New Gene Editing Technology

Broad Institute’s New Prime Editing Tech Corrects Nearly 90 Percent of Human Pathogenic Variants

Researchers at Several Top Universities Unveil CRISPR-Based Diagnostics That Show Great Promise for Clinical Laboratories

New CRISPR Genetic Tests Offer Clinical Pathologists Powerful Tools to Diagnose Disease Even in Remote and Desolate Regions

Harvard Researchers Demonstrate a New Method to Deliver Gene-editing Proteins into Cells: Possibly Creating a New Diagnostic Opportunity for Pathologists

Studies by KHN, Navigant, and Others Report That Independent and Rural Hospitals Are Closing at Record Rates, Leaving Patients Without Critical Nearby Healthcare Services

Negative financials, low population growth, and excess inpatient capacity cited as reasons communities—especially rural areas—may lose their independent hospitals, including access to nearby clinical laboratory testing and anatomic pathology services

Could America’s independent rural hospitals actually disappear altogether? Metrics compiled by multiple healthcare monitoring organizations suggest that, with the increase in mergers and acquisitions of health networks, it’s a distinct possibility.

If so, what would happen to all the clinical laboratories affiliated with and servicing those hospitals? And how might hospital-based medical laboratories that are absorbed into larger healthcare networks be required to alter their workflows? For almost three decades, the clinical laboratory profession has seen similar hospital acquisitions lead to consolidation, standardization, and regionalization of the medical laboratories inside these hospitals. Often these organizational restructurings mean layoffs of lab managers and medical technologists.

Probably the more serious challenge is what will happen to all the rural patients who cannot get to larger health networks located in urban settings.

Hospital Closings Create Risks for Rural Communities

Experts say rural hospitals—especially providers serving small populations in southern and midwestern states—are in precarious positions going forward.

Kaiser Health News (KHN) reported in August that more than 100 rural hospitals closed since 2010, and these closures have serious implications for patients, such as a lengthy transport to another hospital’s emergency department.

“Across America, rural patients spend more time in an ambulance than urban patients after a hospital closes,” Alison Davis, PhD, Professor of Agricultural Economics at the University of Kentucky, and Executive Director of the Community and Economic Development Initiative of Kentucky, told KHN. Her team analyzed ambulance call and transport time data and found that a trip can grow from an average of 14 minutes before a hospital closed to 25 minutes after, KHN reported. (Photo copyright: Northern Kentucky Tribune.)

430 Rural Hospitals Likely to Close!

Rural hospitals usually do not have many nearby competitors. So, what brings so many  of them to the brink of closure? According to a Navigant (NYSE:NCI)) analysis of more than 2,000 rural hospitals, “21% are at high risk of closing based on their total operating margin, days cash-on-hand, and debt-to-capitalization ratio. This equates to 430 hospitals across 43 states that employ 150,000 people!”

Navigant identifies the following as factors in the decline of these struggling rural hospitals:

  • “Low rural population growth;
  • “Payer mix degradation;
  • “Excess hospital capacity due to declining inpatient care; and
  • “An inability for hospitals to leverage technology due to lack of capital.”

Also, a lack of Medicaid expansion has led to rural hospital closures as well, as Dark Daily reported earlier this year in “Rural, For-Profit Hospitals Closing at an Alarming Rate Putting Some Independent Clinical Laboratories and Pathology Groups at Risk,” February 8, 2019.

Navigant goes on to state, “Further review of the community essentiality (trauma status, service to vulnerable populations, geographic isolation, economic impact) of rural hospitals at high financial risk suggests 64% or 277 of these hospitals are considered highly essential to their community’s health and economic well-being. In 31 states, at least half of these financially distressed rural hospitals are considered essential.”

After reviewing the 2,000 rural hospitals Navigant’s analysts concluded that, unless trends reverse, one-in-five rural hospitals (21%) risk closing, a news release stated. And these hospitals are “essential” to the area’s residents.

“We show that two in three of these hospitals are considered highly essential to their communities: that’s 277 hospitals nationwide,” wrote David Mosley, Navigant’s Managing Director, in a STAT blog post. “Furthermore, if these hospitals close, already fragile rural economies will crumble while residents will be forced to travel long distances for emergency and inpatient care.”

Fierce Healthcare noted that “Of Montana’s 12 at-risk rural hospitals, all of them are considered essential to their communities. Kansas has 29 total at-risk rural hospitals with 25 of them—or 86%—considered essential to their communities. Georgia and Mississippi have seen 77% and 61% of their essential rural hospitals at financial risk, respectively.”

Navigant’s list of states with the highest percentage of rural hospitals at risk of closing includes:

  • Alabama: 21 hospitals (50%)
  • Mississippi: 31 hospitals (48%)
  • Georgia: 26 hospitals (41%)
  • Maine: eight hospitals (40%)
  • Alaska: six hospitals (40%)
  • Arkansas: 18 hospitals (37%)
  • Oklahoma: 17 hospitals (29%)
  • Kansas: 29 hospitals (29%)
  • Michigan:18 hospitals (25%)
  • Kentucky: 16 hospitals (25%)
  • Minnesota: 19 hospitals (21%)

Comparing Independent Hospitals to Health Networks

But it’s not just rural independent hospitals that are struggling. Modern Healthcare Metrics reports that 53% of all stand-alone hospitals in the US have suffered operating losses during each of the last five years (2012 to 2017). Conversely, about half (26%) of health system-affiliated providers have lost money.

Statistics compiled by the American Hospital Association (AHA) show there are approximately 5,000 non-federal acute care community hospitals in the US. In 2017, about 75% of them were part of multi-hospital systems, an increase from 70.4% in 2012, Modern Healthcare Metrics data indicated.

Modern Healthcare reported that during the period 2012 to 2017:

  • Average length of stay increased 6.4% at independent hospitals, while it decreased at health system hospitals by 23.5%;
  • Occupancy rates fell to 43.6% from 53.9% at independent providers, compared to rates falling to 53.7% from 61% at system-owned hospitals;
  • Independent hospitals seem to rely on patients having longer lengths of stay;
  • Hospices and skilled nursing facilities compete with stand-alone hospitals.

Change is coming to parts of the nation that depend on independent hospitals, and it’s not good. Medical laboratory leaders are advised to prepare for serving patients who may lose access to nearby tests and diagnostic services. On a positive note, medical laboratories in independent hospitals that consolidate with healthcare systems could bring expertise, adding value to their new networks.

—Donna Marie Pocius

Related Information:

Fewer Independent Hospitals Can Weather Operating Headwinds

The Effect of Rural Hospital Closures on Community Economic Health

American Hospital Association: Fast Facts on US Hospitals

After a Rural Hospital Closes, Delays in Emergency Care Cost Patients Dearly

Rural Hospital Sustainability  

One in Five U.S. Rural Hospitals at High Risk of Closing

Lawmakers Need to Act to Prevent Rural Hospitals Closing

More than One in Five Rural Hospitals at High Risk of Closing: Report

Rural For-Profit Hospitals Closing at an Alarming Rate, Putting Some Independent Clinical Laboratories and Pathology Groups at Risk

At MIT, New DNA Microscopy Maps Cells and Their Genetic Sequences Using Chemicals Rather than Light

Genetic data captured by this new technology could lead to a new understanding of how different types of cells exchange information and would be a boon to anatomic pathology research worldwide

What if it were possible to map the interior of cells and view their genetic sequences using chemicals instead of light? Might that spark an entirely new way of studying human physiology? That’s what researchers at the Massachusetts Institute of Technology (MIT) believe. They have developed a new approach to visualizing cells and tissues that could enable the development of entirely new anatomic pathology tests that target a broad range of cancers and diseases.

Scientists at MIT’s Broad Institute and McGovern Institute for Brain Research developed this new technique, which they call DNA Microscopy. They published their findings in Cell, titled, “DNA Microscopy: Optics-free Spatio-genetic Imaging by a Stand-Alone Chemical Reaction.”

Joshua Weinstein, PhD, a postdoctoral associate at the Broad Institute and first author of the study, said in a news release that DNA microscopy “is an entirely new way of visualizing cells that captures both spatial and genetic information simultaneously from a single specimen. It will allow us to see how genetically unique cells—those comprising the immune system, cancer, or the gut for instance—interact with one another and give rise to complex multicellular life.”

The news release goes on to state that the new technology “shows how biomolecules such as DNA and RNA are organized in cells and tissues, revealing spatial and molecular information that is not easily accessible through other microscopy methods. DNA microscopy also does not require specialized equipment, enabling large numbers of samples to be processed simultaneously.”

The images above, taken from the MIT study, compares optical imaging of a cell population (left) with an inferred visualization of the same cell population based on the information provided by DNA microscopy (right). Scale bar = 100 μm (100 micrometers). This technology has the potential to be useful for anatomic pathologists at some future date. (Photo and caption copyrights: Joshua Weinstein, PhD, et al/Cell.)

New Way to Visualize Cells

The MIT researchers saw an opportunity for DNA microscopy to find genomic-level cell information. They claim that DNA microscopy images cells from the inside and enables the capture of more data than with traditional light microscopy. Their new technique is a chemical-encoded approach to mapping cells that derives critical genetic insights from the organization of the DNA and RNA in cells and tissue.

And that type of genetic information could lead to new precision medicine treatments for chronic disease. New Atlas notes that “ Speeding the development of immunotherapy treatments by identifying the immune cells best suited to target a particular cancer cell is but one of the many potential application for DNA microscopy.”

In their published study, the scientists note that “Despite enormous progress in molecular profiling of cellular constituents, spatially mapping [cells] remains a disjointed and specialized machinery-intensive process, relying on either light microscopy or direct physical registration. Here, we demonstrate DNA microscopy, a distinct imaging modality for scalable, optics-free mapping of relative biomolecule positions.”

How DNA Microscopy Works

The New York Times (NYT) notes that the advantage of DNA microscopy is “that it combines spatial details with scientists’ growing interest in—and ability to measure—precise genomic sequences, much as Google Street View integrates restaurant names and reviews into outlines of city blocks.”

And Singularity Hub notes that “ DNA microscopy, uses only a pipette and some liquid reagents. Rather than monitoring photons, here the team relies on ‘bar codes’ that chemically tag onto biomolecules. Like cell phone towers, the tags amplify, broadcasting their signals outward. An algorithm can then piece together the captured location data and transform those GPS-like digits into rainbow-colored photos. The results are absolutely breathtaking. Cells shine like stars in a nebula, each pseudo-colored according to their genomic profiles.”

“We’ve used DNA in a way that’s mathematically similar to photons in light microscopy,” Weinstein said in the Broad Institute news release. “This allows us to visualize biology as cells see it and not as the human eye does.”

In their study, researchers used DNA microscopy to tag RNA molecules and map locations of individual human cancer cells. Their method is “surprisingly simple” New Atlas reported. Here’s how it’s done, according to the MIT news release:

  • Small synthetic DNA tags (dubbed “barcodes” by the MIT team) are added to biological samples;
  • The “tags” latch onto molecules of genetic material in the cells;
  • The tags are then replicated through a chemical reaction;
  • The tags combine and create more unique DNA labels;
  •  The scientists use a DNA sequencer to decode and reconstruct the biomolecules;
  • A computer algorithm decodes the data and converts it to images displaying the biomolecules’ positions within the cells.
The visualization above was created from data gathered by DNA microscopy, which peers inside individual cells. It demonstrates how DNA microscopy enables scientists to identify different cells (colored dots) within a sample—with no prior knowledge of what the sample looks like. (Photo and caption copyright: Joshua Weinstein, PhD, et al./Cell.)

“The first time I saw a DNA microscopy image, it blew me away,” said Aviv Regev, PhD, a biologist at the Broad Institute, a Howard Hughes Medical Institute (HHMI) Investigator, and co-author of the MIT study, in an HHMI news release. “It’s an entirely new category of microscopy. It’s not just a technique; it’s a way of doing things that we haven’t ever considered doing before.”

Precision Medicine Potential

“Every cell has a unique make-up of DNA letters or genotype. By capturing information directly from the molecules being studied, DNA microscopy opens up a new way of connecting genotype to phenotype,” said Feng Zhang, PhD, MIT Neuroscience Professor,

Core Institute Member of the Broad Institute, and Investigator at the McGovern Institute for Brain Research at MIT, in the HHMI news release.

In other words, DNA microscopy could someday have applications in precision medicine. The MIT researchers, according to Stat, plan to expand the technology further to include immune cells that target cancer.

The Broad Institute has applied for a patent on DNA microscopy. Clinical laboratory and anatomic pathology group leaders seeking novel resources for diagnosis and treatment of cancer may want to follow the MIT scientists’ progress.    

—Donna Marie Pocius

Related Information:

A Chemical Approach to Imaging Cells from the Inside

DNA Microscope Sees “Through the Eyes of the Cell”

DNA Microscopy Offers Entirely New Way to Image Cells

DNA Microscopy: Optics-free Spatio-Genetic Imaging by a Stand-Alone Chemical Reaction

This New Radical DNA Microscope Reimagines the Cellular World

DNA Microscopy Offers a New Way to Image Molecules

DNA Microscope Shows Cells Genetic Material

Trends Reshaping Hospitals Worldwide Also Impact Clinical Laboratories and Anatomic Pathology Groups

As hospitals are forced to innovate, anatomic pathologists and medical laboratories will need to adapt to new healthcare delivery locations and billing systems  

As new challenges threaten the survival of many hospitals worldwide, medical laboratories may be compelled to adapt to the needs of those transforming organizations. Those challenges confronting hospitals are spelled out in a recent report from management consulting firm McKinsey and Company with the provocative title, “The Hospital Is Dead, Long Live the Hospital!

A team of analysts led by McKinsey senior partner Penny Dash, MB BS, MSc, looked at nine trends affecting hospitals in North America, Europe, Asia, and other regions. These trends, the authors contend, will force hospitals to adopt innovations in how they are structured and how they deliver healthcare.

Here are nine challenges hospitals face that have implications for medical laboratories:

1. Aging Patient Populations

“Patient populations are getting older, and their needs are becoming more complex,” McKinsey reports, and this is imposing higher cost burdens. The US Census Bureau projects that by 2030 approximately 20% of the US population will be 65 or older compared with about 15% in 2016.

The federal Centers for Medicare and Medicaid Services (CMS) reports that this age group accounts for a disproportionate share of healthcare costs. In 2014, CMS states, per-capita healthcare spending was $19,098 for people 65 or older compared with $7,153 for younger adults.

The Census Bureau graphic above illustrates how the age of the US population is changing. People are living longer, and as Dark Daily reported in May, this could present opportunities for medical laboratories and anatomic pathologists, as early detection of chronic diseases affecting older patients could ultimately reduce treatment costs. (Photo copyright: US Census Bureau.)

2. Patients Are Behaving More Like Consumers

“Patients—along with their families and caregivers—expect to receive more information about their conditions and care, access to the newest treatments, and better amenities,” McKinsey reports.

Dark Daily has reported extensively on the rise of healthcare consumerism and the opportunities this might offer for clinical laboratories.

3. More Community-based Outpatient Care

Clinical advances are increasing the range of treatments that can be performed in outpatient settings, McKinsey reports. The authors point to multiple studies suggesting that patients can receive better outcomes when more care is delivered outside the hospital. Dark Daily has often reported on the impact of this trend, which has reduced demand for in-hospital laboratory testing while increasing opportunities for outpatient services.

4. Move Toward High-Volume Specialist Providers

Compared with general hospitals, specialized, high-volume “centers of excellence” can deliver better and more cost-effective care in many specialties, McKinsey suggests. As evidence, the report points to research published over the past 12 years in specialist journals.

Some US employers are steering patients to top-ranked providers as part of their efforts to reduce healthcare costs. For example, Walmart (NYSE:WMT) pays travel costs for patients to undergo evaluation and treatment at out-of-state hospitals recognized as centers of excellence, which Dark Daily reported on in July.

UnitedHealthcare’s new preferred lab network also appears to be a nod toward this trend. As The Dark Report revealed in April, the insurer has designated seven laboratories to be part of this network. These labs will offer shorter wait times, lower costs, and higher quality of care compared with UnitedHealthcare’s larger network of legacy labs, the insurer says.

5. Impact of Clinical Advances

Better treatments and greater understanding of disease causes have led to significantly lower mortality rates for many conditions, McKinsey reports. But the authors add that high costs for new therapies are forcing payers to contend with questions about whether to fund them.

As Dark Daily has often reported, new genetic therapies often require companion tests to determine whether patients can benefit from the treatments. And these also face scrutiny from payers. For example, in January 2018, Dark Daily reported that some insurers have refused to cover tests associated with larotrectinib (LOXO-101), a new cancer treatment.

6. Impact of Disruptive Digital Technologies

The McKinsey report identifies five ways in which digital technologies are having an impact on hospitals:

  • Automation of manual tasks;
  • More patient interaction with providers;
  • Real-time management of resources, such as use of hospital beds;
  • Real-time clinical decision support to enable more consistency and timeliness of care; and
  • Use of telemedicine applications to enable care for patients in remote locations.

All have potential consequences for medical laboratories, as Dark Daily has reported. For example, telepathology offers opportunities for pathologists to provide remote interpretation of blood tests from a distance.

7. Workforce Challenges

Many countries are contending with shortages of physicians, nurses, and allied health professionals, McKinsey reports. The authors add that the situation is likely to get worse in the coming decades because much of the current healthcare workforce consists of baby boomers.

An investigation published in JAMA in May indicated that, in the US, the number of active pathologists decreased from 15,568 to 12,839 between 2007 and 2017. In January, Dark Daily reported that clinical laboratories are also dealing with a generational shift involving medical technologists and lab managers, as experienced baby boomers who work in clinical laboratories are retiring.

8. Financial Challenges

In the United States and other countries, growth in healthcare spending will outpace the gross domestic product, the McKinsey report states, placing pressure on hospitals to operate more efficiently.

9. More Reliance on Quality Metrics

McKinsey cites regulations in Canada, Scandinavia, and the UK that require hospitals to publish quality measurements such as mortality, readmittance, and infection rates. These metrics are sometimes linked to pay-for-performance programs, the report states. In the United States, Medicare regularly uses quality-of-care metrics to determine reimbursement, and as Dark Daily reported in July, a new Humana program for oncology care includes measurements for medical laboratories and anatomic pathology groups.

The McKinsey report reveals that several trends in healthcare are forcing healthcare leaders to adopt new strategies for success. The report’s authors state that their “results show that contemporary healthcare providers around the world are facing several urgent imperatives: to strengthen clinical quality; increase the delivery of personalized, patient-centered care; improve the patient experience; and enhance their efficiency and productivity.”

These pressures on hospitals typically also require appropriate responses from clinical laboratories and anatomic pathology groups as well.

—Stephen Beale

Related Information:

The Hospital Is Dead, Long Live the Hospital!

The Nine Forces Changing the World for Hospitals

Older People Projected to Outnumber Children for First Time in US History

CMS: Health Expenditures by Age and Gender

Results of Harvard Study into Medicare Costs Offers Opportunities for Clinical Laboratories

Pathology Groups and Clinical Laboratories Have Unique Opportunity to Take Leadership Role in Healthcare Consumerism

Consumer Trend to Use Walk-In and Urgent Care Clinics Instead of Traditional Primary Care Offices Could Impact Clinical Laboratory Test Ordering/Revenue

Walmart Flies Employees to Top Hospitals for Surgeries in a Bid to Cut Healthcare Costs

New UnitedHealthcare Preferred Lab Network Launches July 1

Precision Medicine Requires Targeted Cancer Therapies, but Payers Reluctant to Pay for Some Genetic Testing Needed to Match a Patient with Right Drug

Telemedicine Gaining Momentum in US as Large Employers Look for Ways to Decrease Costs; Trend Has Implications for Pathology Groups and Medical Laboratories

Trends in the US and Canadian Pathologist Workforces From 2007 to 2017

With Experienced Baby Boomers Retiring in Ever-Larger Numbers, Clinical Laboratories and Pathology Groups Use New Methods to Improve Productivity, Reduce Costs

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

Aspenti Health Takes Home Grand Prize in Nation’s First Clinical Lab 2.0 ‘Shark Tank’ Competition Showcasing Added-Value Clinical Success Stories

Vermont-based clinical laboratory company integrates social determinants of health (SDH) with lab data to help doctors at University of Vermont Health Network better manage their opioid patients

Aspenti Health, a full-service diagnostic laboratory specializing in toxicology screening, has won the nation’s first ever Clinical Lab 2.0 “Shark Tank”! The competition was held May 2, 2019, in conjunction with the 24th Annual Executive War College on Lab and Pathology Management in New Orleans.

The Clinical Lab 2.0 “Shark Tank” showcased forward-thinking clinical laboratories and anatomic pathology groups that are committed to the Clinical Lab 2.0 movement, a Project Santa Fe Foundation initiative aimed at guiding laboratories from test volume to lab value models.

“We are thrilled to be recognized for our work serving the unique needs of substance use healthcare. And, most importantly, across our organization for our unyielding commitment to employing innovations to solve this [opioid] crisis,” Aspenti Health CEO Chris Powell stated in the news release.

The projects were judged on Clinical Lab 2.0 attributes, such as:

  • Risk stratification by population;
  • Closure of care gaps;
  • Lab results as early detection; and
  • Lab intervention for improved clinical outcomes.

“This project, as well as all of the other cases that were presented, were quite strong and all were aligned with the mission of the Clinical Lab 2.0 Movement,” said Khosrow R. Shotorbani, President, Executive Director, Project Santa Fe Foundation, in a news release. “This movement transforms the analytic results from a laboratory into actionable intelligence at the patient visit in partnership with front-liners and clinicians—allowing for identification of patient risks—and arming providers with insights to guide therapeutic interventions.

“Further, it reduces the administrative burden on providers by collecting SDH [social determinants of health] predictors in advance and tying them to outcomes of interest,” continued Shotorbani. “By bringing SDH predictors to the office visit, it enables providers to engage in SDH without relying on their own data collection—a current care gap in many practices. The lab becomes a catalyst helping to manage the population we serve.”

Co-Use of Opioids Tied to Social Factors

Aspenti Health’s “Shark Tank” entry—“Integration of the Clinical Laboratory and Social Determinants of Health in the Management of Substance Use”—focused on the social factors tied to the co-use of opioids and benzodiazepines, a combination that puts patients at higher risk of drug-related overdose or death. The project revealed the top two predictors of co-use were the:

  • Prescribing provider practice, and the
  • Patient’s age.
“This was a unique project because it integrated social determinants, which are a key part of our overall health and wellness, with laboratory data, which is well-defined, quantitative, and very accurate,” said Jill Warrington, MD, PhD (above), Chief Medical Officer at Aspenti Health and Assistant Professor in the Department of Pathology and Laboratory Medicine University of Vermont Medical Center, in an exclusive interview with Dark Daily. “So, combining something that is really meaningful clinically with something that is very predictive and accurate has a nice blend of strengths.” (Photo copyright: Aspenti Health.)

Myra L. Wilkerson, MD, who served on a three-judge panel tasked with selecting the winning project, said the Vermont toxicology laboratory’s entry stood out in two key areas.

“We felt their project had an application to a broader population, but also moved beyond traditional [laboratory] functions or even medicine,” explains Wilkerson, who is Chair of the Diagnostic Medicine Institute for the Geisinger Health System. “Patient advocacy groups, payers, and providers all have come to realize you can identify a disease, you can provide a treatment, but so many other things impact it, especially in this community. When it is an addiction, there are so many other factors that play into whether or not they are going to be successful in their treatment plan. And a lot of them are social things.”

Educating Care Givers and Public on Dangers of Co-Use Drug Addictions

Working in collaboration with Staple Health and the University of Vermont Health Network, Aspenti selected “co-use” for this initial lab outcome study because of the significant patient safety implications and relative simplicity of its definition—the co-presence of positive laboratory results for both opioids and benzodiazepines.

According to the National Institute on Drug Abuse, more than 30% of overdoses involving opioids also involve benzodiazepines. Aspenti’s “Shark Tank” presentation highlighted the fact that co-use of the drugs accounts for nearly 2.5% of opioid-related emergency department visits, costing the healthcare system an estimated $47.5 million per year.

Based on the study results, Aspenti Health plans to develop educational programs that warn about the dangers of co-using opioids and benzodiazepines.

“We identified geographically hotspots where co-use was more prevalent, so we can target our educational initiatives centered on those geographical locations—not just to providers, but also to families and patients—to raise awareness about co-use so the risks are mitigated collectively,” Warrington said.

Advancing the Value-based Healthcare Agenda

The Executive War College Clinical Lab 2.0 “Shark Tank” advances a conversation about the lab industry’s future that began at the inaugural 2016 Project Santa Fe meeting. Lab industry stakeholders brainstormed about the transition from volume-based to value-based healthcare, and the role laboratory-driven innovations could play in reducing total cost of care.

As healthcare shifts to a value-based reimbursement model, Wilkerson believes laboratory leaders must re-engineer their role in the continuum of care by creating meaningful clinical diagnostic insights for population health initiatives.

“What’s your executive leadership concerned about? What are your payers concerned about? What are your accrediting or regulatory bodies concerned about? What are their top priorities and how can you do something that improves patient care but helps them address their problems as well?” she asks. “That’s where you create value.”

As the Clinical Lab 2.0 Innovation Award winner, Aspenti Health will receive:

  • An invitation to speak at national lab conferences this fall;
  • A consultation with a Project Santa Fe member lab to discuss successful Clinical Lab 2.0 innovations and identify new ways to deliver more value in patient care; and
  • Publication of a case study of their Clinical Lab 2.0 project by Dark Daily or its sister publication The Dark Report.

With labs in Vermont and Massachusetts, Aspenti continues to identify opportunities for directly contributing to improvements in the care of substance abuse and pain management patients. Warrington says that with its SDH project, Aspenti plans to focus on other key laboratory outcome measures—such as treatment adherence and relapse. Next steps include integrating this work into the practices of partner doctors within the University of Vermont Health Network.

Wilkerson’s advice to other clinical laboratories is to follow Aspenti Health’s lead.  

“When you look at the national trends, the percentage of traditional fee-for-service or volume-based healthcare is going to go down to 25% of the total healthcare spend by 2021,” she points out. “The other 75% will be based on value-added services around quality metrics, efficiency, cost reduction, utilization, etc. Labs that aren’t starting to think this way now are going to be behind and at risk in the future.”

—Andrea Downing Peck

Related Information:

Aspenti Health Wins Clinical Lab 2.0 Innovation Award

First-Ever ‘Shark Tank’ on Clinical Lab 2.0 and Adding Value Happens May 2 in New Orleans: Clinical Laboratories with Innovative Services Invited to Present

Improving American Healthcare Through “Clinical Lab 20”: A Project Santa Fe Report

National Institute on Drug Abuse: Benzodiazepines and Opioids

Project Santa Fe Labs Deliver Value with Tests

Improving American Healthcare Through “Clinical Lab 2.0”: A Project Santa Fe Report

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