As demand for genetic tests increases, so does the call for clinical laboratories to process and analyze the data, and work with ordering physicians to explain test results to patients
According to a 23andMe press release announcing the results of two national surveys, “most people and doctors agree that genetic testing offers promise for more personalized healthcare.” This is positive for clinical laboratories that provide genetic testing. These two surveys indicate a growing understanding among physicians and healthcare consumers of genetic testing’s value to effective precision medicine.
The surveys were conducted by Medscape, an online resource of medical information owned by WebMD, and Material, an international firm that partners with companies to provide strategy, insights, design, and technology, according to its website. Direct-to-consumer (DTC) genetic testing company 23andMe commissioned the surveys.
The researchers found that 75% of patients in the US said, “they’d be more likely to follow a doctor’s advice if they knew their genetic profile was used to personalize their care.”
The survey also revealed that:
92% of doctors in the US say genetics is an important part of a patient’s complete health picture.
66% of doctors say genetic testing could help lead to better outcomes for patients.
“I am excited about a future where genetic information becomes the foundation of personalized health,” said Anne Wojcicki, 23andMe co-founder and CEO, in a press release. “And that future may help alleviate some issues already affecting the population.” Recent surveys commissioned by 23andMe that indicate both physicians and patients are becoming more accepting of genetic tests are good news for clinical laboratories that perform genetic testing. (Photo copyright: TechCrunch/Wikimedia Commons.)
Filling a Need for Personalized Healthcare
Elective genetic testing is not only becoming more popular with doctors and patients, it may also fill a key precision medicine need in the population. According to the researchers, “more than half of people surveyed (55%) said they don’t feel healthy today, and 63% said they don’t feel in control of their health. And while most people surveyed (62%) said they wanted advice from their doctors that was tailored to them personally, few, only about 36%, said that’s what they were getting,” the press release noted.
Clearly, demand for a pathway to more personalized healthcare exists in the market. Thus, companies that offer elective genetic testing are looking to fill that need.
Genetic testing kits from companies such as 23andMe and Ancestry have become increasingly popular over the past few years. People often turn to these DTC companies to learn about their heritage, but they also allow healthcare consumers to take part in elective genetic testing without needing a referral from a doctor.
Before the popularity of these DTC tests, most genetic testing only took place when ordered by a healthcare provider. But that may be changing. According to a study conducted by Global Markets Insights (GMI), the size of the DTC genetic testing market “surpassed USD $3 billion in 2022 and is predicted to expand at over 11.5% CAGR [compound annual growth rate] from 2023-2032.”
GMI also predicted that “rising prevalence of genetic disorders will accelerate [genetic testing] industry growth.”
Problems and Opportunities in Genetic Testing
As consumer demand for elective genetic testing has increased, certain issues and opportunities have arisen as well.
In an article she penned for STAT titled, “Why the Rise of DNA Testing Is Creating Challenges—and An Opportunity,” physician/scientist Noura Abul-Husn MD, PhD, Vice President of Genomic Health at 23andMe, wrote, “This rapid growth has created what some might see as a big problem and others might see as an opportunity.” Abul-Husn is also Associate Professor of Medicine and Genetics, and Clinical Director of the Institute for Genomic Health, at the Icahn School of Medicine at Mount Sinai.
“The problem? There hasn’t been a corresponding increase in genetics education and training healthcare providers about it, meaning that many people are reaching out to healthcare providers who are ill-prepared to incorporate genetic test results into clinical practice,” she wrote.
“The opportunity? Results from genetic testing can help healthcare providers engage with their patients on a deeper level about personal health risks, promoting health, and preventing disease,” she added.
Growing Need for Processing and Analyzing Genomic Tests
A YouGov survey of 1,000 adults between February 9 and February 12, 2022, showed that two of every 10 Americans have taken a DTC genetic test. But it seems healthcare professionals currently lack the training to incorporate genetic test results into their patients’ care. This may present an opportunity for the genetic testing industry to meet the demand of its consumers.
The growing popularity of elective genetic testing will also increase demand for clinical laboratories to process and analyze these types of tests. And that will drive increased revenue and job opportunities in those labs.
Another factor that is positive about the increased acceptance and interest in genetic testing by doctors and consumers is that this creates a demand by employees for their company health plan to cover genetic tests. Each year, going forward, employers will recognize that their employees want genetic tests and so will take steps to make such tests a covered benefit within the health plan. That is also a positive market factor for those medical laboratories offering genetic testing.
It seems clear that elective genetic testing offers individuals the opportunity to work with their physicians to design personalized treatments based on their unique conditions. And it gives the healthcare industry—including clinical laboratories—the opportunity to expand services and branch out. The future of precision medicine may lie within our genes.
Research shows face-to-face genetics counseling overcomes barriers to proceeding with genetic testing and increases chances of catching cancer early
Research funded by the Prostate Cancer Foundation (PCF) has found that when patients receive in-person genetics counseling instead of virtual telehealth consultation, they are more likely to complete full germline genetic testing.
Clinical laboratory professionals have long been aware, at least anecdotally, that when physicians hand medical laboratory test orders to patients, a high percentage do not follow through and provide blood specimens for testing.
According to a PCF press release, with an on-site genetics counseling program “genetic testing occurs at the time of the consult,” whereas “with the telegenetics model, testing kits are mailed to the veteran’s home to be completed later, which can be a significant barrier, particularly for veterans with unstable housing. Researchers also explain that a face-to-face interaction with a trusted healthcare provider may be a better forum for having psychosocially complex genetic counseling discussions than telemedicine.”
This insight may be useful for genetic testing labs that can arrange for personal counseling of patients whose physician has recommended a complete full germline genetic test. Those labs would likely see a higher proportion of genetic test referrals convert into actual tests because more patients would decide to proceed.
“Without a doubt, telemedicine has many benefits, but this research shows that when it comes to genetic counseling and testing, in-person consults are most impactful,” Howard R. Soule, PhD, PCF Executive Vice President and Chief Science Officer, said in the press release.
Prostate Cancer Foundation Executive Vice President and Chief Science Officer Howard R. Soule, PhD said in-person counseling for genetic testing is more effective than a telehealth consult. Clinical laboratories are familiar with the problem of patients not following through on doctors’ orders for lab testing. (Photo copyright: Prostate Cancer Foundation.)
Germline genetic testing identifies inherited mutations that may be linked to cancer. In at-risk individuals, it plays a role in secondary screening, and it is also an element in treating prostate and other cancers.
The patients in the study were referred for cancer genetics services between October 1, 2020, and February 28, 2022, the JCO Oncology Practice paper noted. About two-thirds (65%) were referred due to a personal history of cancer and 26% due to family history of cancer. More than half self-identified as Black.
Among the 238 patients, 130 received telehealth genetic counseling compared with 108 who were counseled onsite. A total of 117 patients in the study underwent the genetic testing.
The researchers found that among all patients in the study, those who received on-site counseling had a 3.2-fold higher likelihood of completing the genetic testing compared with the telehealth service. Among the patients who self-identified as Black, the likelihood was 4.8-fold higher. The study also found that those who received on-site counseling were less likely to miss follow-up care.
The study noted some demographic differences between the two groups: Veterans seen onsite had a median age of 71 and 92% were male. Among those who received telegenetics counselling, the median age was 57 and 58% were male.
Barriers to Genetic Testing
“Barriers to genetic testing—such as lack of access to cancer genetic services and an overall shortage of genetics service providers, both within and outside of the VA—translate to missed opportunities to diagnose cancer earlier, identify at risk family members, and offer precision oncology treatment,” the press release states.
Citing previous studies, the researchers noted that barriers to completion of genetic testing “have been magnified among racial minorities, even in cases for which there is a clear indication for testing, or if the testing is provided free of cost.”
One goal of the study, the researchers wrote, was to determine if on-site consultation could help overcome those barriers.
These consultations “can be complex encounters, and for patients with active cancer, they occur during a stressful period of their care,” the researchers wrote. The consults should include “the benefits and limitations of testing, different types of test results, and the risk of psychological impact of test results.”
Possible Explanations for Genetic Test Completion Rates
The researchers pointed to several possible explanations for the differences in testing rates. The on-site genetics nurse “has flexibility to see patients in the same physical space as their oncology follow-up or treatment visits.” The study found that this led to better attendance at appointments.
In addition, those patients received testing during the consultation. However, patients who underwent genetics counselling received their testing kits by mail. “This time delay allows for multiple intervening factors that could affect the completion of genetic testing,” the researchers wrote.
The researchers also suggested that patients may be more inclined to trust providers with whom they have face-to-face interactions.
“Our findings suggest that the presence of an on-site genetics service can potentially mitigate [racial] disparities, while effectively increasing the proportion of completed [genetic tests] for patients regardless of racial or ethnic background,” they wrote.
“Although telegenetics has greatly expanded access to genetics evaluations, it is possible that a face-to-face interaction with a provider onsite may be a better method for delivery of genetics consultations, given the inherent complexity in these encounters, particularly in the veteran population,” the researchers noted in JCO Oncology Practice. “It is imperative to optimize these interactions and facilitate genetics services follow-up, as the ultimate results from testing—if indicated—have profound implications on matters that are important to patients.”
Though the PCF study is confined to genetic testing and does not encompass all clinical laboratory testing, those with experience in medical laboratories know a high percentage of patients do not complete doctor-ordered lab tests.
“Going as far back as the 1990s, there has been recognition among pathologists and clinical laboratory managers that, as a rule of thumb, for every 100 lab test orders a doctor hands to patients, only 60% of those patients come in and provide a blood specimen,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “To my knowledge, there’s never been a published study about this aspect of clinical laboratory testing that has appeared in a peer-reviewed medical journal.
“Over the years, fear of needles was believed to be one reason why some patients accept a lab test order from their physician but do not take the next step of providing a specimen to a clinical lab,” Michel added. “Today, with high-deductible health plans and expensive genetic tests, cost would be another reason why patients might decline to go forward with lab tests ordered by their physicians.”
Study may lead to repurposing existing drugs that are proven to be safe for the treatment of related diseases as the interactome becomes the subject of more research efforts
Researchers from multiple scientific institutions working together have begun using the protein interactome to understand what combination of unique biomarkers is a reliable indicator that a specific drug would benefit a patient. Armed with that knowledge, pharmaceutical companies plan to develop a drug that benefits individuals who have that collection of biomarkers/interactome.
Of course, once the drug exists, the next step is to develop a clinical laboratory test that looks for those biomarkers so that patients can be diagnosed and identified as candidates for the new drug treatment.
Microbiologists and clinical laboratory scientists engaged in “omic” studies—such as genomics, proteomics, metabolomics, metagenomics, phenomics, and transcriptomics—know that scientists are increasingly working to use ever-larger numbers of biomarkers to collectively identify if an individual patient would benefit from a specific drug. This ongoing research is at the heart of precision medicine treatments.
“This work bridges many fields of biology, including statistical genetics, cell biology, and bioinformatics,” said Pedro Beltrão, PhD, Professor in the Department of Biology at ETH Zürich’s Institute of Molecular Systems Biology and former group leader at EMBL-EBI. Microbiologists and clinical laboratories engaged in “omic” studies will understand the significance of this study. (Photo copyright: Gulbenkian Science.)
Study Finds Biological Support for Repurposing Existing Drugs
According to Genetics Engineering and Biotechnology News (GEN), “A protein interactome—the network of all possible protein interactions—constitutes an important intermediary step that could bridge the often difficult to cross chasm between genotype [an organism’s complete set of genetic material] and phenotype [an organism’s observable characteristics or traits], and is key in identifying drug targets.”
The scientists discovered more than 1,000 human traits from 21 therapeutic areas, GEN reported. Their process identified drug targets and genes linked to diseases because it pinpoints the shared basis of diseases utilizing a map of interactive human proteins.
The more defined the links are between genetic mechanisms, human traits, and diseases, the more likely their methods can help pharmaceutical companies prioritize those targets for new drugs, and for potentially repurposing existing FDA-approved drugs, the scientists noted.
The study accessed multiple databases including Reactome, Signor, and the EMBL-EBI’s IntAct. The researchers used genome-wide association studies (GWAS) to identify interacting protein groups that were genetically linked.
“The interactome identified some known associations, such as cardiovascular diseases and lipoprotein or cholesterol measurements,” Inigo Barrio Hernandez, PhD, a postdoctoral fellow at Open Targets and EMBL-EBI, told GEN. “But we also found some unexpected associations. For example, the interactome highlighted three protein clusters shared by ten respiratory and skin immune-related diseases. This is hugely exciting because we now have some biological support to repurpose existing drugs that are proven to be safe to treat related diseases.”
The researchers also identified 73 protein clusters linked to more than one trait or disease. This is known as pleiotropy. Pleiotropic relationships are goldmines to drug companies because they show how a therapy for one disease could effectively treat another, and in addition, it provides insight on targets that could trigger side effects, GEN reported.
What Comes Next?
Pedro Beltrão, PhD—Biology Professor at ETH Zürich’s Institute of Molecular Systems Biology and former group leader at EMBL-EBI—noted the significance of this collaborative study. “It brought together groups from across Open Targets and EMBL-EBI and highlights the value of collaborations across disciplines,” he told GEN.
The study researchers plan to continue identifying, mapping, and utilizing their findings for drug development.
“This is an exciting showcase … that has generated an array of new insights for novel target discovery as well as drug repurposing, and informs our understanding of the connection between rare and common diseases through shared biological processes,” Ellen McDonagh, PhD, Director of Informatics Science at Open Targets, told GEN. “This is now being developed further to provide tissue and cell-type specific networks to help further prioritize targets for disease treatment.”
The term “interactome” was coined in 1999, but many microbiologists and clinical laboratory scientists may not be familiar with it. Considering the possibility of new drug therapies based on these newly discovered biomarkers—and the medical laboratory tests that will be needed to identify compatible patients—it’s a good idea to stay aware that protein interactome exists.
Researchers are working to identify the protein interactome, map it, and use it—both in drug discovery and development—as well as in clinical laboratory testing. More research and study is needed, so a medical lab test that advances patient care is a ways off. But the research is worth following.
Level 3 bio labs handle Ebola, smallpox and other deadly diseases, and may play a role in research into the human genome
Because of the COVID-19 pandemic, there is a concerted effort to improve public health laboratories and increase the growth of bioresearch. Clinical laboratories across the country are required by law to send specimens of certain infectious diseases to public health labs for testing and analysis. The results of those tests are then reported to the federal Centers for Disease Control and Prevention (CDC), which is working to foster robust connections and relationships between clinical labs and public health labs.
A land transaction for a 1.6-acre purchase between Dallas County and TXRE Properties closed in April. The development of the lab is expected to cost $52 million and should be completed by late 2025 with occupancy as early as January 2026.
The graphic above is an artist rendering of what the new Dallas County Health and Human Services Public Health Laboratory may look like. For some time now, Dallas County has been working to create a hub centered around infrastructure and buildings to be used for bio development and research, public health labs, and even clinical laboratories. (Graphic copyright: 5G Studio Collaborative.)
Continuing Support for HHS
“The large-scale response required for COVID-19 demonstrated the need for the acquisition that will permit the continued support of the HHS efforts in response to the ongoing safety, containment, incident response to emerging and high consequence diseases that could operate at the peak of a crisis without hindering or being hindered by other county operations,” states a Dallas County Commissioners Court Order, D Magazine reported.
“The county currently utilizes owned facilities to provide laboratory services, testing services, and other initiatives,” according to the court order. “These facilities have performance and design shortcomings and have required significant capital expenditure for their ongoing use.
“To avoid leasing space and avoid additional capital investment into deferred and ongoing maintenance, the county has been searching for a suitable location/acquisition to collocate uses/departments into a centralized, efficient, and suitable laboratory,” the court order continued.
Lab Will Conduct Research into Potentially Fatal Diseases
The facility will pursue becoming a Biological Safety Level-3 laboratory. BSL-3 labs typically conduct research or work on microbes that can cause serious and potentially fatal disease through inhalation. These labs are required to be easily decontaminated. They must also have additional safety measures, including interlocked doors, sealed windows, floors, and walls, and filtered ventilation systems.
“The core diagnostic functions are—along with safety—related to identification, containment, security, and incident response to emerging and high consequence diseases,” the court order notes.
A Georgetown University article published last year concluded there are 148 institutions with BSL-3 laboratories in the US. This number was established by identifying and totaling the number of BSL-3 facilities that published research between 2006 and 2021 using PubMed Central, a full-text archive of biomedical and life sciences journal literature at the US National Institutes of Health’s National Library of Medicine (NIH/NLM).
The creation of this new biosafety lab in Dallas is consistent with the trend of investment dollars being poured into research into the human genome. This type of research, along with the creation of new facilities, can directly lead to new biomarkers that can be utilized in clinical laboratory testing and disease prevention.
The speakers also noted that labs must learn to work collaboratively with payers—perhaps through health information technology (HIT)—to establish best practices that improve reimbursements on claims for novel genetic tests.
Harnessing the ever-increasing volume of diagnostic data that genetic testing produces should be a high priority for labs, said William Morice II, MD, PhD, CEO and President of Mayo Clinic Laboratories.
“There will be an increased focus on getting information within the laboratory … for areas such as genomics and proteomics,” Morice told the keynote audience at the Executive War College on Wednesday.
“Wearable technology data is analyzed using machine learning. Clinical laboratories must participate in analyzing that spectrum of diagnostics,” said William Morice II, MD, PhD (above), CEO and President of Mayo Clinic Laboratories. Morice spoke during this week’s Executive War College.
Precision Medicine Efforts Include Genetic Testing and Wearable Devices
For laboratories new to genetic testing that want to move it in-house, Morice outlined effective first steps to take, including the following:
Determine and then analyze the volume of genetic testing that a lab is sending out.
Research and evaluate genetic sequencing platforms that are on the market, with an eye towards affordable cloud-based options.
Build a business case to conduct genetic tests in-house that focuses on the long-term value to patients and how that could also improve revenue.
A related area for clinical laboratories and pathology practices to explore is their role in how clinicians treat patients using wearable technology.
For example, according to Morice, Mayo Clinic has monitored 20,000 cardiac patients with wearable devices. The data from the wearable devices—which includes diagnostic information—is analyzed using machine learning, a subset of artificial intelligence.
In one study published in Scientific Reports, scientists from Mayo’s Departments of Neurology and Biomedical Engineering found “clear evidence that direct seizure forecasts are possible using wearable devices in the ambulatory setting for many patients with epilepsy.”
Clinical laboratories fit into this picture, Morice explained. For example, depending on what data it provides, a wearable device on a patient with worsening neurological symptoms could trigger a lab test for Alzheimer’s disease or other neurological disorders.
“This will change how labs think about access to care,” he noted.
For Payers, Navigating Genetic Testing Claims is Difficult
While there is promise in genetic testing and precision medicine, from an administrative viewpoint, these activities can be challenging for payers when it comes to verifying reimbursement claims.
“One of the biggest challenges we face is determining what test is being ordered. From the perspective of the reimbursement process, it’s not always clear,” said Cristi Radford, MS, CGC, Product Director at healthcare services provider Optum, a subsidiary of UnitedHealth Group, located in Eden Prairie, Minnesota. Radford also presented a keynote at this year’s Executive War College.
Approximately 400 Current Procedural Terminology (CPT) codes are in place to represent the estimated 175,000 genetic tests on the market, Radford noted. That creates a dilemma for labs and payers in assigning codes to novel genetic tests.
During her keynote address, Radford showed the audience of laboratory executives a slide that charted how four labs submitted claims for the same high-risk breast cancer panel. CPT code choices varied greatly.
“Does the payer have any idea which test was ordered? No,” she said. “It was a genetic panel, but the information doesn’t give us the specificity payers need.”
In such situations, payers resort to prior authorization to halt these types of claims on the front end so that more diagnostic information can be provided.
“Plans don’t like prior authorization, but it’s a necessary evil,” said Jason Bush, PhD, Executive Vice President of Product at Avalon Healthcare Solutions in Tampa, Florida. Bush co-presented with Radford.
[Editor’s note: Dark Daily offers a free webinar, “Learning from Payer Behavior to Increase Appeal Success,” that teaches labs how to better understand payer behavior. The webinar features recent trends in denials and appeals by payers that will help diagnostic organizations maximize their appeal success. Click here to stream this important webinar.]
Payers Struggle with ‘Explosion’ of Genetic Tests
In “UnitedHealth’s Optum to Offer Lab Test Management,” Dark Daily’s sister publication The Dark Report, covered Optum’s announcement that it had launched “a comprehensive laboratory benefit management solution designed to help health plans reduce unnecessary lab testing and ensure their members receive appropriate, high-quality tests.”
Optum sells this laboratory benefit management program to other health plans and self-insured employers. Genetic test management capabilities are part of that offering.
As part of its lab management benefit program, Optum is collaborating with Avalon on a new platform for genetic testing that will launch soon and focus on identifying test quality, streamlining prior authorization, and providing test payment accuracy in advance.
“Payers are struggling with the explosion in genetic testing,” Bush told Executive War College attendees. “They are truly not trying to hinder innovation.”
For clinical laboratory leaders reading this ebriefing, the takeaway is twofold: Genetic testing and resulting precision medicine efforts provide hope in more effectively treating patients. At the same time, the genetic test juggernaut has grown so large so quickly payers are finding it difficult to manage. Thus, it has become a source of continuous challenge for labs seeking reimbursements.
Heath information technology may help ease the situation. But, ultimately, stronger communication between labs and payers—including acknowledgement of what each side needs from a business perspective—is paramount.
From ‘new-school’ rules of running a clinical laboratory to pharmacy partnerships to leveraging lab data for diagnostics, key industry executives discussed the new era of clinical laboratory and pathology operations
Opening keynotes at the 28th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management taking place in New Orleans this week covered three main forces that healthcare and medical laboratory administrators should be preparing to address: new consumer preferences, new care models, and new payment models.
“COVID-19 didn’t change a whole lot of things in one sense, but it accelerated a lot of trends that were already happening in healthcare,” said Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and Founder of the Executive War College, during his opening keynote address to a packed ballroom of conference attendees. “Healthcare is transforming, and the transformation is far more pervasive than most consumers appreciate.
“Disintermediation, for example, is taking traditional service providers and disrupting them in substantial ways, and if you think about the end of fee-for-service, be looking forward because your labs can be paid for the value you originate that makes a difference in patient care,” Michel added.
Another opportunity for clinical laboratories, according to Michel, is serving Medicare Advantage plans which have soared in enrollment. “Lab leaders should be studying Medicare Advantage for how to integrate Medicare Advantage incentives into their lab strategies,” he said, highlighting the new influence of risk adjustment models which use diagnostic data to predict health condition expenditures.
Opening sessions at this week’s annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, presented by Robert L. Michel (above), Editor-in-Chief of Dark Daily and its sister publication The Dark Report, discussed demand for delivering healthcare services—including medical laboratory testing—as consumer preferences evolve, new care models are designed, and as payers seek value over volume. While these three forces may be challenging at the outset, they also create opportunities for clinical laboratories and pathology groups—a focal point of the Executive War College each year. (Photo copyright: The Dark Intelligence Group.)
Medical Laboratories Must Adapt to ‘New-School’ Rules
During his keynote address, Stan Schofield, Vice President and Managing Principal at The Compass Group, noted that while the basic “old-school” rules of successfully running a clinical laboratory have not changed—e.g., adding clients, keeping clients, creating revenue opportunities, getting paid, and reducing expenses—the interpretation of each rule has changed. The Compass Group is a trade federation based in South Carolina that serves not-for-profit healthcare integrated delivery networks (IDNs), including 32 health systems and 600 hospitals.
Schofield advised that when it comes to adding new clients under the “new-school” rules of lab management, clinical laboratory directors must be aware of and adapt to hospital integrations of core labs, clinical integrations across health systems, seamless services, direct contracting with employers in insurance relationships, and direct-to-consumer testing. Keeping clients, Schofield said, involves five elements:
Strong customer service.
A tailored metrics program for quality services based on what is important to a lab’s clients.
Balanced scorecards that look at the business opportunity and value proposition with each client.
Monitoring patients’ experiences and continuous improvement.
Participation in all payer agreements.
As to the problem of commoditization of laboratory goods and services, Schofield said, “Right now, we’re facing the monetization of the laboratory. We’re going to swiftly move from commoditization to monetization to commercialization.”
Pharmacies Enter the Clinical Laboratory Market
In another forward looking keynote address, David Pope, PharmD, CDE, Chief Pharmacy Officer at OmniSYS, XiFin Pharmacy Solutions, discussed the “test to treat” trend which could bring clinical laboratories and pharmacies together in new partnerships.
Diagnostics and pharmacy now intersect, according to Pope. “Pharmacists are on the move, and they are true contender as a new provider for you,” he said. “An area of pharmacy that is dependent upon labs is specialty medications.”
Specialty medicines now account for 55% of prescription spending, up from 28% in 2011, driven by growth in auto-immune and oncology, Pope noted. Other examples include companion diagnostics required for targeted treatments pertaining to all major cancers, and new areas like thalassemia (inherited blood disorders), obesity, next-generation sequencing, and pharmacogenomics, in addition to routine testing such as liver function and complete blood count (CBC).
Federal legislation may soon recognize pharmacists as healthcare providers who will be trained to perform specific clinical services, Pope said. Some states already recognize pharmacists as providers, he noted, explaining that pharmacies need lab data for three primary reasons:
Service—Pharmacies can act as a referral source to clinical laboratories. When referring, pharmacies may need to communicate lab test results to patients or providers to coordinate care.
Value-based care—Pharmacies would draw on data to counsel, prescribe, and coordinate care for chronic disease management, among other services.
Diagnostics and pharmacogenetics—Specialty medication workflows require documented test results within a specific timeframe prior to dispensing.
Another point Pope made: Large pharmacies are seeking lab partners. Labs that can provide rapid turnaround time and good pricing on complex tests provide pharmacies with partnership opportunities.
Using AI to Create Patients’ ‘Digital Twins’ That Help Identify Disease and Improve Care
High-tech healthcare technology underlies many opportunities in the clinical laboratory and pathology market, as evidenced throughout the Executive War College’s 2023 curriculum. An ongoing challenge for labs, however, is how to produce the valuable datasets that all labs have the potential to generate.
“It feels like we’ve come so far,” explained Brad Bostic, CEO of hc1 during his keynote address. “We’ve got the internet. We’ve got the cloud. All of this is amazing, but in reality, we have this massive proliferation of data everywhere and it’s very difficult to know how to actually put that into use. And nobody’s generating more data than clinical laboratories.
“Every single interaction with a patient that generates data gives you this opportunity to create the idea of a ‘digital twin.’ That means that labs are creating a mathematical description of what a person’s state is and using that information to look at how providers can optimally diagnose and treat that person. Ultimately, it is bigger than just one person. It’s hundreds of millions of people that are generating all this data, and many of these people fall into similar cohorts.”
This digital twin opportunity is heavily fueled by medical laboratory testing, Bostic said, adding that labs need to be able to leverage artificial intelligence (AI) to:
“I recommend lab leaders sit down with their teams and any outside partners they trust and identify what are their lab’s goals,” Bostic stated. “Think about how this technology can advance a lab’s mission. Look at strategy holistically—everything from internal operations to how patient care is affected.”
