Consolidation, legislation, new testing modalities, and a shift to more consumer-driven testing are just some of the clinical laboratory predictions for 2024.
By Chris Wolski
For its third annual look-ahead, CLP recently asked a wide range of clinical laboratory experts to look into their professional crystal balls and make their predictions for 2024.
The following, in no particular order, are their top 16 predictions.
#1. Staffing Shortages will Continue Despite a Push for High Wages
It’s no secret that clinical labs are facing significant staffing shortages, in part, due to the exponential demand for laboratory testing.
As CLP editorial advisory board (EAB) Member Rachele Moore, MBA, MLS (ASCP),
notes, demand isn’t the only reason we’re facing a dearth of new laboratorians, and the solution isn’t as simple as throwing money at it.
“Laboratories are currently struggling with a severe shortage of medical laboratory professionals due to various factors such as the closure of training programs, a decrease in student applicants, and financial constraints,” says Moore, who is also executive director, laboratory services for the Aultman Health Foundation. “To address this shortage, it is essential for laboratories to work towards competitive compensation, a positive work culture, and opportunities for career advancement. By doing so, they can attract and retain skilled staff to meet the growing demand for laboratory testing.”
And, while increased compensation can help, Moore adds that there are other considerations to take into account.
“Despite the challenges faced by laboratories, there is a growing focus on talent acquisition and retention,” she says. “Organizations are increasingly recognizing the need to offer competitive wages and benefits to attract qualified individuals. However, it is not enough to solely rely on high salaries. Creating a positive work environment and career growth opportunities are equally crucial for retaining talent in the long run.”
#2. Clinical Laboratories will Continue to Lean into Using AI, Machine Learning, and Digital Workflows
Clinical labs, as with other industries, have seen artificial intelligence, machine learning, and digital workflows changing and evolving the way they do business. Nikos Pavlidis, acting president of BD Diagnostic Solutions, sees this continuing into 2024.
“There’s no doubt that automation and informatics remain powerful drivers in clinical labs,” he says. “With staffing shortages still challenging the field, it’s critical for labs to deploy automation and processes from pre-analytical to testing and result reporting, supported by informatics-enabled interconnected workflows, to improve efficiency and allow laboratorians to spend less time on burdensome manual processes and more time on complex tasks.”
Pavlidis isn’t the only one seeing 2024 as increasing digital. Michelle MacPherson, director of Hematology Product Management for Beckman Coulter Diagnostics, foresees a digital transformation in hematology.
“With the dawn of digitization of cellular images behind us, we now have the foundation to conceivably accelerate precision medicine using cellular morphology to better understand disease, monitor treatment, and predict outcomes with significantly higher accuracy,” she says. “Hematology testing, namely the complete blood count (CBC) is an integral part of the medical evaluation and workup of patients, and with less than 100 µL of blood, we can guide the diagnostic pathway in diseases such as malaria, leukemia, and anemia. The advent of machine learning and deep learning has now afforded us the opportunity to learn more about disease and therapy by not only digitizing all the information but also by combining this with other tests and patient information. This will ultimately lead to earlier detection, more effective treatments, and better care management—all with a purple top tube.”
#3. Clinical Lab Offerings will Support Non-Traditional Health Care Delivery
The global COVID-19 pandemic changed many aspects of medicine, including increasing awareness of the value of clinical testing. It also began an evolution in the way health care was delivered to patients.
Pavlidis foresees laboratory services evolving to meet non-traditional delivery of medical care in 2024.
“Another trend is the modernization of the lab offerings to support the evolution of healthcare delivery conducted at non-traditional sites (like at home) or through virtual visits, as well the need to increase access through the expansion of outreach programs,” he says.
Brad Moore, president and CEO of Roche Diagnostics North America, sees the trend more broadly with the benefit being improved access to care.
“New, innovative ways of testing are driving diagnostics physically closer to the patient. This will ultimately broaden access to care and potentially help improve overall patient outcomes, specifically in disease areas, such as sexual health, where there are disparities or stigma,” he says. “Innovation and technology will continue to be important in diabetes care, the area of diagnostics that has historically been the closest to the patient. People with diabetes appreciate modern diabetes-management tools that ease the stress and anxiety of their condition. They value ease of use, accuracy, reliability, and support for tracking the data they need every day to stay on top of their management of everything from carbohydrates to HbA1c.”
#4. Self-Collection will Empower Patients and Improve Care
While access is a real issue for many patients, some find the process of having samples taken difficult for a number of personal, cultural, or logistical reasons. Pavlidis predicts that self-collection is going to be a game changer for labs.
“The availability of self-collection is going to be a significant enabler that will allow labs to deliver valuable services to the population they serve and improve access; take HPV self-collection as an example,” he says. “Self-collection for HPV testing is already in use in many countries around the world. Efforts are underway to bring that option to the U.S. and if there is timely approval by the FDA, we could see—hopefully would see—an increase in HPV screening, meaning more people with a cervix taking advantage of the convenience and privacy of self-collection to do critical screening. Denmark, for example, saw an additional 31% of previously unscreened women participating in the country’s national HPV program after being offered the option to self-collect. More self-collected tests going to the labs will require labs to better leverage their scale and capacity to optimize their performance and standardize quality and costs of diagnostics, where again, automation and informatics will help.”
#5. The Convergence Between Life Sciences and Diagnostics Becomes Real
One-size-fits-all medicine is ending with personalized, tailor-made treatments arising in its place. That’s the prediction of Yves Dubaquie, PhD, senior vice president of Revvity. But that’s only the first step in creating a more dynamic health care environment.
“Siloes and technological gaps stand in the way of personalized medicine reaching its fullest potential,” he says. “As science becomes both more complex and more personalized, we will see even greater collaboration between life sciences and diagnostics. This convergence is key to helping drive new scientific breakthroughs in laboratories, bringing a new product through the clinic, and ultimately tailoring a unique diagnostic which can help identify individuals who stand to benefit the most from this new therapeutic or cure. This full ‘continuum’ involving research to development, diagnosis to cure, will improve healthcare for everyone, everywhere.”
#6. Climate Change will Fuel the Need for New Diagnostics
Climate change is certainly impacting many discussions about the future. Regular CLP contributor Tyler Radke, MLS(ASCP)CM , is among those who see new threats to our health growing due to climate change and other factors.
“There continues to be an ongoing battle slowly occurring over time with resistance development in Candida auris, Candida glabrata, and Candida krusei likely due to antifungal pressures,” he says. “Some of which may be due to improved treatments and prolonged lifespans for immunocompromised patients, creating a new type of environment for opportunistic yeast and molds.”
And while it’s unlikely we’ll see an apocalyptic outbreak a la The Last of Us, the threat of fungal infections are growing, says Radke.
“A great example of the ever-widening spread of molds is a fascinating paper from the Washington University School of Medicine. That team concludes that dimorphic molds are increasingly found in areas beyond their historically endemic geography,” he says. “With headlines like these, it is hard to imagine fungal infections not becoming a larger focus for the laboratory community. With luck, this will lead to enhanced diagnostic testing methods beyond the tools we have today, all of which have significant limitations in speed, technical complexity, sensitivity, specificity, or cost. Some progress is being made with a newly developed assay to detect antibody to Coccidioides spp.”
Rodney E. Rohde, PhD, SM(ASCP)CM, SVCM, MBCM, FACSc, Regents’ professor and global fellow in the Medical Laboratory Science Program at Texas State University, also predicts that both emerging and re-emerging infectious diseases “will continue to amplify in the face of ongoing travel, climate, geopolitical, and other changes.” He cites, specifically antimicrobial resistance as a continuing global problem.
#7. The use of Biomarkers will Improve Diagnosis of Multiple Diseases
Every day it seems there are new biomarkers being discovered for a range of diseases, aiding earlier diagnosis and better, more efficacious treatments. Expect to see more of this, according to Stephanie Franco, PhD, senior scientific affairs liaison for EUROIMMUN (Part of Revvity)
“With the excitement surrounding the FDA approval of Leqembi and pending approval of donanemab (anti-amyloid treatments for Alzheimer’s disease (AD), we see further clinical investigations into blood based biomarkers (BBBMs) and genetic screening as imperative to furthering improvements in AD diagnosis and treatments,” she says. “It has been demonstrated that ApoE e4 carriers are at a higher risk for developing amyloid related imaging abnormalities (ARIA) when undergoing anti-amyloid treatments, such as Leqembi and donanemab. Thus, it has been recommended in the Leqembi instructions for use to perform ApoE genetic screening prior to treatment, which suggests this genetic screen could become a requirement for treatment. Furthermore, several new and existing biomarkers in plasma (e.g p-tau-217) are being investigated as having value in accurate diagnosis and treatments which are more economically friendly, easily accessible and less invasive than CSF draws and PET screens. We also see further investigations into combination therapies with targets other than amyloid to help reduce cognitive decline in patients with mild to moderate AD. Further exploration of BBBMs and ApoE genetic testing are surely to be pivotal in the next chapters of AD diagnosis and treatments. The changing landscape of Alzheimer’s disease research and clinical trial data presented at the most recent Clinical Trials for Alzheimer’s Disease (CTAD) conference was described as profound and we agree.”
Heading into 2024, labs and healthcare institutions are expanding their in-house capabilities to meet increased demand for testing via CSF and PET scan imaging, the only FDA cleared methods currently available to confirm amyloid pathology, which also is required for the new therapies, according to Roche’s Brad Moore.
Similarly, Moore sees biomarkers helping to better identify and treat diseases beyond Alzheimer’s.
“For instance, the American Diabetes Association (ADA) recommends that people with diabetes undergo a yearly risk assessment to detect early heart failure, even if they do not currently have any symptoms,” he says. “The guidance calls for testing to detect elevated B-type natriuretic peptide levels and/or unusual levels of high-sensitivity cardiac troponin, which are biomarkers of underlying cardiovascular disease and may be elevated prior to developing symptoms.”
#8. Innovative TB Diagnostic Tests will be Developed as a Part of the Disease Eradication Strategy
While tuberculosis is a preventable and curable disease, it continues to claim countless lives yearly, particularly in low- and middle-income countries. Ruth Brignall, PhD, global scientific affairs manager at Revvity, predicts that new testing types will be key to eradicating the disease.
“Current diagnostic tests for active TB rely on microbiological confirmation of TB bacteria from sputum samples, or visual signs of TB in the lung observed on a chest X-ray. As a result, around 36% of new TB cases, who do not have pulmonary TB or cannot produce a sputum sample, go undiagnosed or unreported. The main challenge lies in the absence of non-sputum-based diagnostics. Developing accurate non-sputum-based tests is crucial to diagnose individuals suffering with active TB who cannot produce sputum,” she says. “In 2024, we expect the development of innovative TB diagnostics, like non-sputum-based diagnostics, to begin addressing unmet needs within the TB space. We also anticipate that we will see improved access to existing tests for better coverage where needed the most.”
#9. Increased Oversight of LDTs by the FDA
The FDA’s proposal to increase oversight of laboratory-developed tests (LDTs), could have profound effects on the clinical laboratory industry and patient care, predicts CLP EAB member and Chief Science Officer of Sinai Labs Ron Blum, PhD.
“In 2022, Congress failed to pass the VALID act, which was legislation aimed at shifting oversight of LDTs from CLIA to the FDA. At that time, FDA officials indicated that if the VALID act did not pass, they were planning to unilaterally issue their own proposal to regulate LDTs,” says Blum. “In his analysis, Bruce Quinn, MD, PhD, an expert on health care reimbursement and policy, identifies some staggering cost estimates that the FDA believes will be required to implement their oversight—to the tune of $50 billion. The FDA claims they want to regulate LDTs to improve test quality and patient safety, but many of the examples they cite as reasons to implement the oversight are incorrect. LDTs have played a vital role in filling critical health care gaps for testing in underserved populations, particularly in cancer, genetics, and infectious disease, and forcing laboratories to submit their novel assays through the FDA process would be stifling to innovation and actually hurt those whom the FDA is claiming would be helped by more rigorous oversight.”
#10. Risk Stratification for Prognosis will Grow as a Support Tool for Patients with Chronic Diseases
For patients with chronic conditions, better understanding of disease progression will likely take the form of new testing types, according to Sharon Bracken, head of Diagnostics for Siemens Healthineers.
“There is an area of opportunity within each disease state to support patients early in their diagnoses, to ideally prevent their diseases from progressing,” she says. “Until new biomarkers are revealed or established to support the development of assays capable of earlier disease diagnosis, the focus—in parallel—will be on more immediate opportunities to support patient care through prognostication and risk-stratifying patients who are at higher risk of progressing to more advanced disease stages. Identifying these patients can support more efficient monitoring of their disease progression and even earlier delivery or modification of treatment. We can anticipate these early-intervention tools will take the form of assays and AI algorithms and they are very much on the horizon. The greatest obstacle to utilizing these new tools to their highest potential will be the accessibility of diverse data sets representing real world scenarios.”
#11. Minimal Residual Disease (MRD) Testing will Become a Standard of Care in Oncology
Minimal residual disease testing using a simple blood draw to help identify cancer cells in circulating tumor DNA after an initial treatment, will become more widely adopted, according to Yuri Fesko, MD, vice president, medical affairs, oncology, for Quest Diagnostics.
“We expect this to become more widely adopted, along with other advanced diagnostic technologies like next-generation sequencing for tumor analysis to help select a treatment,” he says. “Physicians typically monitor patients over several years for signs of cancer recurrence, using tests that include tissue biopsy or imaging. However, biopsies and imaging can be invasive, inconvenient or expensive, so MRD testing provides a new and complementary way to help monitor for residual or recurring cancer longitudinally over time through a simple blood test. About 1.9 million people will be diagnosed with cancer this year. Cases of cancer continue to increase across the country, with more aggressive cases also spiking for certain cancers and among younger people. Precision medicine tools like those that can test for MRD will be vital to address cancer recurrence—not only in 2024, but beyond—and help ensure better health outcomes.”
#12. Next-Generation Sequencing will Advance Newborn Screening
Next-generation sequencing (NGS) has been used to test for a wide-range of conditions in the clinical laboratory, but it gives clinicians powerful tools to provide care to newborns, according to Madhuri Hegde, FACMG, SVP and chief scientific officer of Revvity.
“Next-generation sequencing (NGS) is providing efficient, holistic insights into the human genome, which has become a viable option for population-wide screening, including within newborn screening (NBS),” says Hegde. “A recent study conducted by Revvity Omics has shown the clinical value of proactive, sequencing-based screening in apparently healthy newborns. The use of proactive genomic screening would enable healthcare professionals to uncover a wide range of risks for looming pediatric onset conditions, allowing for earlier interventions and personalized treatment plans based on individual genetic makeup. As NGS becomes more accessible to the general public, harnessing this tool could have a profound impact on the health and wellbeing of families and future generations.”
#13. There will be Further Consolidation of Clinical Laboratory and Diagnostic Companies
The pandemic offered companies many opportunities and has made the value of testing top of mind for clients and stakeholders. However, Blum predicts that this has come at an ongoing cost: consolidation.
“One of the striking features of the 2023 AACC/ADLM conference was the multitude of companies which are now under the umbrella of larger diagnostic corporations. The various corporate names and logos appearing on the walls of the exhibits were a kind of ‘NASCAR of the lab and diagnostic industry.’ With the waning of COVID and subsequent decrease in compulsory testing revenue, diagnostic companies and laboratories have been pressured to make up for the financial losses in a variety of ways including layoffs, closures, and increased mergers and acquisitions. Additional drivers in this consolidation include ongoing proposed cuts to reimbursement for lab testing by PAMA and a shrinking labor pool of skilled professionals,” he observes. “Companies are diversifying their testing technologies and disease states and seeking new revenue streams in ancillary segments to supplement decreased demand and economic pressures. With the economy in a downturn, it appears the consolidation trend will continue in 2024, particularly as uncertainty grows with who will be leading the country in 2025.”
#14. Innovation in Multi-Drug-of-Abuse Testing will Become Common
Overshadowed in some ways by the pandemic, the opioid crisis is now becoming a priority, particularly with new psychoactive drugs are coming on the scene. This will require ongoing innovation in testing, according to Jack Kain, PharmD, director & medical science liaison, Drug Monitoring & Toxicology for Quest Diagnostics.
“Over the past 10-15 years, the opioid epidemic has continued to evolve, passing through periods rife with misuse of prescription opioids and, in recent years, fentanyl. I predict that 2024 will mark a new phase: the novel psychoactive drug epidemic. Novel psychoactive substances (NPS) are a range of drugs that have been designed to mimic established illicit drugs like cannabis, cocaine, MDMA, and LSD. Illicit manufacturers of these drugs develop new chemicals to replace those that are banned, making the long-term effects of these substances impossible to track by physicians and unpredictable for those who use them,” says Kain. “While NIDA reports deaths involving synthetic opioids and stimulants continue to rise across the country, the emergence of these new designer drugs have evaded detection by current testing methods. NPS must be monitored to prevent harm in communities, but many labs are not currently testing for them. We anticipate laboratories will develop new test methods in 2024 such as xylazine and other NPS that emerge as public health threats.”
#15. The Quest to Live Longer will Drive Diagnostics Further into the World of Consumerism
The pandemic has caused a shift about how people handle all aspects of their health, and Bracken sees this continuing in a profound way into 2024.
“The pandemic forever changed the way people think about diagnostic testing. They once gave little thought to getting bloodwork done at the doctor’s office or a collection location, but COVID opened the door to self-collection, testing in new locations, ordering one’s own blood work direct from a lab, and other non-traditional processes,” she says. “One unexpected plot twist was the rise of social media influencers sparking interest in the concept of longevity. Influencers are no longer limited to product recommendations—instead they’re taking their fascinated followers along on their quests to live longer, healthier lives. In fact, recent data reveals that in the last year, patients have placed more trust in their friends and family when it comes to health information—rising peer influence to an equivalent level of trust they place in doctors and nurses. Furthermore, 44% of young adults (ages 18-34) believed their own research can make them just as knowledgeable on most health matters as doctors. This mindset will drive greater consumerization of diagnostics and a focus on wellness and longevity at a more accelerated pace as more people take their healthcare into their own hands. The current workforce shortage across the healthcare system will create a prime opportunity for this shift to occur.”
#16. T-Cell Testing will Gain Further Traction in Long COVID and CAR-T Therapy
T-cell testing offers a number of diagnostic opportunities—particularly for identifying and helping to treat long COVID and validating CAR-T cell therapy, according to James Foster, CEO of Virax Biolabs.
“While CAR-T cell therapies have shown remarkable success in some cancer patients, there is a need for robust validation methods to ensure their safety and efficacy. T-cell testing plays a pivotal role in this validation process by assessing the functionality, specificity, and persistence of CAR-T cells,” he says.
According to Foster T-cell testing helps by identifying functionality, confirm specificity, and persistence of long-term CAR-T cell therapies.
“T-cell testing has emerged as a powerful tool in the validation of CAR-T cell therapies for cancer treatment and the advancement of Long COVID-19 research. Its ability to assess the functionality, specificity, and persistence of CAR-T cells ensures safer and more effective treatments for cancer patients. Simultaneously, in the context of Long COVID-19, T-cell testing helps unravel the complexities of the immune response, potentially leading to improved management strategies for this enigmatic condition,” Foster adds. “As research in both fields continues to evolve, T-cell testing is likely to play an increasingly vital role in shaping the future of CAR-T cell therapies and our understanding of Long COVID-19. By harnessing the power of T-cell testing, we can bring about innovative therapies and insights that have the potential to transform the landscape of healthcare.”
The Clinical Laboratory: Looking Beyond the Predictions
While there is no guarantee that any of the above predictions will come true—it is likely that we will see change in the coming year.
Chris Wolski is chief editor of CLP.
