Continued staffing shortages, more industry consolidation, and the growing ubiquity of at-home testing are just a few of the predictions that clinical laboratory experts are making for 2023.
By Chris Wolski
CLP recently asked clinical laboratory industry experts to weigh in on their predictions for the coming year. Following, in no particular order, are the top 10 predictions for 2023.
Podcast: The Big Challenges Facing Clinical Labs
#1 – COVID-19 Will Transition to an Endemic Phase and Continue to Impact Laboratory Operations
Unsurprisingly, COVID-19 continues to figure into many of the predictions for 2023. Manoj Gandhi, MD, PhD, senior medical director for Thermo Fisher Scientific, outlines what endemicity will look like, at least for the near term.
“The SARS-CoV-2 virus will continue to evolve as we keep fighting to protect against variants already in circulation. It remains to be seen how the future variants behave from a disease perspective; but it’s unlikely that the virus will be eradicated,” he predicts. “While many governments have loosened public health countermeasures such as social distancing and mask mandates, it will be important for the general public to be responsible, vigilant, and thoughtful of when it might be wise to wear a mask, get tested, and get the next available booster. Public health laboratories and researchers will need to monitor the evolution of the virus through strain surveillance and look for new mutations which may impact the performance of diagnostic tests and the efficacy of existing treatments and vaccines, which will inform the development of new vaccines.”
COVID-19 as an endemic disease will not only continue to impact society as a whole, but, more specifically, the operation of the clinical laboratory.
“As COVID-19 volumes moderate, labs now have much more molecular testing capacity and capability than they did prior to the pandemic,” predicts Dara Grantham Wright, executive VP & president of Bio-Rad Laboratories’ Clinical Diagnostics Group. “This capacity will impact new test adoption opportunities, consolidation of testing between platforms, and will impact send out practices. As part of this dynamic, the industry should also expect to see continued growth in syndromic multiplex testing and point of care testing.”
#2 – The 2022-2023 Flu Season Will Likely Be the Worst Since the Onset of the Pandemic
Last year harbored well-founded fears that the 2021-2022 flu season would usher in a “twindemic,” further straining overstretched hospital and clinical laboratory resources. That prediction was wrong—thankfully—but of all the predictions on this year’s list, this appears to be the one most likely to come true.
Since society has opened back up and disease countermeasures have relaxed—e.g. social distancing, masking, and testing—the U.S., and the rest of the world, look on track to have a tough, or at least tougher, flu season than in recent years, according to Gandhi. This is why testing is critical in tackling it.
“Since the beginning of the pandemic, public health experts have been worried about the impact when Flu and COVID-19 are co-circulating,” notes Gandhi. “Being that this is the first flu season since we’ve been ‘fully back’ since COVID-19 first emerged, without public health countermeasures in place, there is a high likelihood that there is a resurgence of Influenza. It is important to recognize that standard flu kills tens of thousands of people every year in the United States alone. We’ve already seen the rebound of Influenza during the past winter in the southern hemisphere and early signs indicate that the flu season may have arrived earlier than expected in the northern hemisphere, as well. Since there are different antivirals to treat these two separate diseases and it is difficult to differentiate between them based on symptoms alone, it will be important to test for these pathogens. The availability of SARS-CoV-2 and Influenza combination tests will be critical in the effort to expedite diagnoses and better inform treatment decisions.”
And with COVID-19 still freely circulating, co-infections could deliver on last year’s prediction of a so-called “twindemic.”
“Following the successful rollout of the COVID-19 vaccination program, populations are beginning to have increased levels of interactions once again as restrictions have been lifted. This poses a risk of co-infections of COVID-19 with other respiratory pathogens, particularly as we enter flu season in the northern hemisphere over the winter months,” says Pardeep Sharda, senior product manager at the Native Antigen Company. “These co-infections could cause complications in diagnosis, treatment, and prognosis of patients, putting pressure on healthcare systems. Any future vaccination programs therefore would most likely involve a combination of COVID-19 and Influenza strains, especially for the most vulnerable groups, such as the elderly or immune compromised individuals.”
#3 – Staff Shortages Will Drive the Need to Increase Automation Processes
Perhaps as a sign of clinical laboratories themselves returning to normal is the renewed focus on a perennial problem: staff shortages, along with a need to invest in automation.
“With an unprecedented shortage of qualified technologists and technicians to staff labs, and the cost to employ them on the rise, more and more labs will be motivated to automate manual processes in 2023 to relieve their staffing burden and gain cost certainty,” says Suren Avunjian, founder and CEO of LigoLab. “By implementing the right technology and adding automation where possible to clinical and billing workflows, labs will be able to fill the gaps created by a lack of qualified personnel. They’ll also enjoy streamlined and more efficient operations. Upgrading away from legacy LIS will not only drive efficiencies in their organizations but also open up new opportunities to retain and capture new revenue streams.”
And because of this need, it’s predicted that there will be more automated solutions to choose from.
“We will see more automated solutions come to market enabling labs to free up personnel for more sophisticated work where their expertise is needed,” predicts Carola Schmidt, general manager of automated robotic solutions at PerkinElmer. “These solutions will also be proven to improve the accuracy and throughput needed to enable physicians to make critical, time-sensitive clinical decisions 24/7. It will be important to seek out lab automation that is SMART: scalable, modular, agile, reliable, and tailor-made to accommodate various needs.”
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It’s also predicted that these solutions will continue to get smarter with artificial intelligence (AI) playing a critical role.
“The challenges faced by laboratories—increased demand, burnout, and staffing shortages— coupled with the always-on demand and expectation for accuracy, precision and efficiency are ushering in a new, arguably overdue, era of diagnostics that will make a difference in the industry. Because these challenges have been heightened by the pandemic, we will see AI begin to play a more prominent role in laboratories across the country,” predicts Nikos Pavlidis, vice president/general manager Molecular Diagnostics & Women’s Health & Cancer, BD Integrated Diagnostic Solutions. “In 2023, we will see AI become even more critical as labor burnout and shortages will continue to be a challenge laboratories face. Laboratories will leverage the automation they have been given access to during the pandemic and drive the consolidation of testing on fully automated platforms. AI can have a significant impact across all different areas of testing by optimizing workflow, testing sequence, result interpretation, and result augmentation. AI can also provide lab techs longer walk-away times and allow them to focus their skills, attention, and expertise on more complex work.”
While automation will likely help alleviate some of the burdens of staff shortages in the clinical laboratory, finding personnel will continue to dominate operational efficiency.
“Many healthcare organizations are struggling financially due to the effects of COVID-19 which have forced laboratories to become more efficient and effective1. Vacancy rates will also continue to climb,” predicts Rachele Moore, MBA, MLS (ASCP), executive director of Laboratory Services for Aultman Health Foundation in Canton, Ohio, and a member of CLP’s editorial advisory board. “According to Silva2, many lab positions have been unfilled for months, leaving laboratories short-staffed. Laboratory leaders should learn and understand their local state and federal qualifications for testing personnel, which can allow flexibility with certain duties.”
#4 – Direct-to-Consumer Solution and Telemedicine Will Open New Revenue Channels for Clinical Laboratories
In the wake of every major crisis, typically there are deep-seated cultural changes that inform the way we live. This is particularly the case with COVID-19; home testing has become ubiquitous. And because patients now expect it, clinical laboratories diagnostic testing is shifting further from traditional collection sites, such as providers’ offices or hospitals, and over to homes and pharmacies.
“The COVID-19 pandemic accelerated a shift to new care settings from the hospital to the home. In 2023 and beyond, common and routine healthcare testing will expand from traditional, acute care centers to any care setting, including urgent care, surgery centers, retail clinics, and even into the home. We will see expanded self-collection and at-home testing, which will create new and incremental opportunities for laboratories,” predicts Pavlidis of BD Integrated Diagnostic Solutions. “We have already seen how consumers are opting for the convenience and comfort of self-collection and at-home testing. In 2023, as options for self-collection and at-home testing will grow, there will ultimately be higher volumes of samples which need to be sent to laboratories to be tested.”
While this will change the way labs operate, Suren of LigoLab predicts that it could result in a windfall.
“Advances in technology and a combination of consumerism and proactive management of healthcare by patients will further open up new revenue channels for clinical laboratories in 2023. This will help combat negative trends like rising operational costs and lower margins on tests rendered,” he says. “By embracing the use of direct-to-consumer patient portals with telemedicine capabilities, labs will be able to directly connect with patients and satisfy their growing demand for easy and convenient access to a marketplace that offers them enhanced specialized laboratory services. In addition to having easy and convenient access to diagnostic testing and preventative screenings on demand, patients will also need assistance to better understand their lab reports and test results. In 2023 they’ll be able to get this too in the form of remote sessions with a medical professional right on the patient portal.”
Local pharmacies, which played a critical role during the height of the COVID-19 pandemic, will continue to play an expanded role in delivering primary care, including testing, predicts Ronald A. Blum, PhD, chief executive officer of Blum & Associates Consulting, LLC, and a CLP editorial advisory board member.
“COVID accelerated the adoption of telemedicine and expanded the role of pharmacies as centers for lab testing, in addition to their traditional role of dispensing prescription medications and immunizations. This new paradigm will continue to grow as pharmacies expand their primary care services,” he says. “Pharmacies around the country, including CVS HealthHub/Minute Clinic, Walgreens Health, and Walmart Health, are already providing in-person and telehealth visits to address a wide range of conditions, including women’s health, allergies, respiratory infections, STDs, type 2 diabetes, sleep disorders, high blood pressure, and mental health. As the public becomes more comfortable utilizing the pharmacy as an alternative to traditional primary care physician office visits, the adoption of additional healthcare services, including lab testing, will increase.”
Blum added that there will be three main areas of expanded clinical laboratory testing: point-of-care (POC) testing, including rapid influenza, COVID, RSV, and other respiratory infections; direct-to-consumer (DTC) test kits, e.g., COVID test kits, allowing patients to self-collect samples at home; and pharmacy-established partnerships with laboratories that can deliver rapid, routine testing from specimens collected at the pharmacy.
“These expanded options for patient testing will help transition the drug stores into one-stop-shops for primary healthcare visits and expanded laboratory testing,” Blum adds.
#5 – Molecular and Other Advanced Testing Types Will Gain Further Footholds
During the pandemic, molecular testing came into its own, and experts expect that this is only the beginning.
“Polymerase Chain Reaction (PCR) technology has established itself as the gold standard for COVID-19 testing. The entire scientific community, including medical professionals, public policymakers, regulatory bodies, and test manufacturers, has seen the merits of PCR testing for infectious diseases. There will be a need to expand the infectious disease testing menu beyond SARS-COV-2. Multiplex tests, including targeted panels as well as a syndromic panel for specific indications, will continue to become the norm,” predicts Gandhi of Thermo Fisher Scientific. “Such tests will not only inform whether the individual has an infection or not, but will also be able to identify the type of pathogen as well as the antimicrobial resistance, so that appropriate treatment can be initiated. For specific use cases, demand for point-of-care molecular testing will continue because of the value a quick result can provide to identify the pathogen and with appropriate empiric treatment. In addition to health care professionals, the average consumer is now well educated. When individuals feel sick, they will know to get tested, find out what’s wrong, and take the appropriate avenue for recovery and safety. These new, highly educated, consumers will expect a test that is accurate, and quick, which are qualities that PCR testing uniquely provides over traditional culture-based methods.”
It’s expected that molecular testing won’t just be used for infectious diseases. Its role will continue to expand.
“It is also likely that molecular testing capacity will be used for non-infectious disease testing demand such as oncology, immune response, and women’s health,” predicts Grantham Wright of Bio-Rad. “Workflow efficiency will continue to be a primary topic of conversation as labs work hard to calibrate to staffing constraints. Creative, affordable solutions will be sought by health systems to maintain levels of service while supporting high-quality clinical care. Companies able to offer innovative solutions to support both lab productivity and high quality will continue to be successful. The evolution of digital health including the integration of multiple data sets, remote diagnostics, and artificial intelligence is also expected to accelerate to support distributed lab operations, data management, and data interpretation.”
A bold prediction sees molecular testing as the future of diagnostics.
“Multiomics is the future of biological analysis,” predicts Madhuri Hegde, PhD, SVP, and chief scientific officer at PerkinElmer Genomics. “In the year ahead we can expect continued advances in related technologies. Whole genome sequencing (WGS) continues to prove its utility in the diagnosis of rare/complex and common diseases, with some estimates showing that this method improves diagnostic yield by 40% to 60%. The emerging field of metagenomics in clinical research settings also shows promise. Discoveries enabled by this next-generation multiomics approach leading to data convergence from different platforms for clinical care combined with microbial and viral genome analysis, will ultimately help genetic counselors and clinicians reach diagnoses faster and initiate actions to improve health outcomes for patients they serve.”
#6 – AI and Machine Learning will Drive Personalized Care
It is becoming clear that a blanket approach to patient care isn’t always effective. AI and machine learning will help pathologists and primary care providers to develop more personalized approaches to cancer and other treatments.
“Many decisions for personalized oncology treatment plans and care pathways are based on patient results generated from companion diagnostics assays, which will place an increasing burden on pathology and genomic services. Artificial Intelligence could play a pivotal role in reducing this strain by assisting healthcare professions in interpreting tissue and/or genomic data,” predicts Sharda of the Native Antigen Company. “This would streamline workflows, improve accuracy, and free up scientists to focus on more complicated cases. There are currently some barriers to adoption, for example, data storage limitations and a lack of clinical evidence on accuracy. However, as data storage solutions become more affordable year on year, and machine learning/computer processing powers increase reliability, trust will grow, and these challenges will be overcome.”
This personalized approach to care will extend throughout the healthcare enterprise.
Clearly, one size does not fit all when it comes to medicine. We should consider dose optimization of every therapeutic and take the guesswork out of the equation. Key to developing a modern approach to healthcare and improving patient outcome relies on comprehensive understanding of an individual’s response to medication through real-time feedback and then using this information to personalize drug dosing decisions: Predict optimal dose – take dose – measure response – adjust dose,” says Hakim Yadi, PhD, OBE, co-founder and CEO of Closed Loop Medicine. Global advances in technology and digital therapeutics (DTx) development have enabled decentralized data acquisition and real-time processing, driving the shift from a standardized to personalized treatment. Integrating digital health tools and medical devices with prescribed therapeutics is challenging the historical disease- and symptom-management paradigm. These combination drug plus software offerings have the potential to accelerate the movement toward accessible precision medicine and personalized dosing optimization, whilst offering necessary support to healthcare providers.
#7 – Increased Adoption of Digital Pathology
Blum predicts that digital pathology will continue to play a key role in pathology and clinical laboratory medicine, noting that much of this was necessitated by the demands of the COVID-19 pandemic requiring remote review and signing out of cases. This was digital pathology’s proof of concept.
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“This past June, the College of American Pathologists (CAP) worked with American Medical Association (AMA) CPT Editorial Panel to create 13 new digital pathology add-on codes that will be used to report work and service requirements performed by clinical staff for the digitization of glass slides intended for primary diagnosis. These codes will take effect in January 2023,” he says. “There still remain multiple barriers to widespread adoption, including regulations, the high cost of equipment, training, validation, workflow, and probably most importantly, lack of reimbursement that would justify the higher expended costs and efforts of integrating digital pathology into the traditional laboratory workflow. Despite these obstacles, the value of digital pathology in allowing rapid remote second opinions and consultations, shorter sign-out times, enhanced data retrieval and integration, as well as the opportunity for AI assistance for enhanced analysis, are helping to drive the process forward.”
#8 – There will be more Late-Stage Cancer Diagnoses
While the pandemic has ushered in the use of more advanced diagnostic technologies and empowered patients with home testing, it also resulted in many patients missing or delaying many routine diagnostic screenings.
“A recent Quest Diagnostics Health Trends report3 showed that, more than two years after the pandemic began, diagnoses of breast and prostate cancer (two of the nation’s leading causes of cancer death) continue to lag behind pre-pandemic levels. Based on 1.1 million de-identified lab results, the analysis found that cancer diagnoses plummeted by close to 30% in the first few months of 2020, when much of society and healthcare shut down. The findings suggest more people are living with undiagnosed cancers now than prior to the pandemic,” says Harvey W. Kaufman, MD, senior medical director and head of the Health Trends Research Program for Quest Diagnostics. “A delayed cancer diagnosis can lead to more advanced disease, more aggressive and costly treatment and worse outcomes, so labs may have to grapple with these negative effects when patients return to care. Given these trends, lab directors will play a critical role in helping their medical teams develop programs to encourage patients to return to care and reduce the time between screening, diagnosis and treatment.”
This will mean that coordination between the clinical laboratory and oncologists is predicted to be more important than ever before.
“As more aggressive, late-stage cancers are anticipated to be uncovered3 in 2023 in part due to delays in screenings from the pandemic, reducing the time between diagnosis and treatment–and ensuring patients receive the best treatment as soon as possible without needing to switch plans–is crucial to saving lives. Given that patients whose cancer treatment is delayed by even one month have, in many cases, a 6% to 13% higher risk of dying4, it is critical for physicians to remain in lockstep with the medical oncologist and diagnosing pathologist, and medical team who diagnosed, to ensure alignment and provide testing in accordance with current guidelines,” says Yuri Fesko, MD, vice president of Medical Affairs and Oncology at Quest Diagnostics. “While this may sound easy, it requires extensive logistics and coordination in the lab to be both timely and comprehensive. Labs will need to implement systems and solutions to ease this process, provide cohesion, and remain organized.”
#9 – Vigilance Towards Outbreaks and Emerging Infectious Diseases
If anything, the pandemic has served as a warning that new outbreaks are not a matter of if but when. We have already experienced this at a smaller scale with the recent monkeypox outbreak and, more troubling, a growing number of Ebola cases in Africa. Vigilance will now become the diagnostic watchword as Gandhi explains.
“Emerging from the pandemic that has impacted the whole world, there will be increased scrutiny and sensitivity towards any emerging infectious diseases,” he predicts. “There must be measures that need to be in place that can be deployed at very short notice. We have already witnessed this in the case of monkeypox. While monkeypox has been around since the 1970s in African countries, it is important not to assume that an outbreak won’t spread or will remain contained on its own. COVID-19 has provided us with key learnings that have helped us to respond more effectively to such outbreaks. We know that testing should be made easily available including at the point-of-care or at-home so that patients can get diagnosed and take precaution as needed. In this regard, it is important to acknowledge the willingness of regulatory agencies to provide a path for getting relevant tests, treatments, and vaccines out in a swift manner through the emergency use authorization (EUA) process. We have also witnessed sporadic outbreaks of the poliovirus identified through wastewater surveillance that has resulted in swift public policy response around polio. Similarly, the WHO recently released a priority list of fungal priority pathogens with recommendations on the surveillance strategy and prevention of antifungal drug resistance.”
To Gandhi’s point, there’s a prediction that we’ll see more versions of more familiar diseases—which may be tougher to diagnose—in the near future.
“Tick-borne diseases (TBDs) have become a global public health challenge. In recent years, both tick-borne pathogens and TBD cases have increased globally. TBDs are the most common vector-borne diseases in the U.S., with Lyme disease being the most reported TBD. Furthermore, tick surveys have shown that tick populations have expanded to new areas of the country at a rapid rate. As more cases are being reported, it will be critical to detect TBDs accurately and rapidly in order to provide early treatment. Emerging TBDs include the Powassan virus, which is mainly transmitted by the same ticks as Lyme disease. With the expanding territory of I. scapularis, and significant increases in the number of Powassan cases in the last decade, there is an urgent need for methods to detect POWV and other non-Lyme TBDs,” says Maite Sabalza, PhD, scientific affairs manager for PerkinElmer’s EUROIMMUN US division.
#10 – There will be Increased Consolidation of Clinical Laboratories
Another prediction is the continued industry consolidation, which already seems to be playing out. But as Blum of Blum and Associates Consulting notes, it will bring more benefits to the organizations and the communities they serve.
“Integration of health services that combine lab testing, anatomic pathology, imaging, radiology, and treatment centers will continue to expand, in efforts to cut costs, increase efficiency, and improve quality of care,” he predicts. “Increased consolidation also means better buying power and the ability to purchase state-of-the-art technology, such as digital pathology, that will allow these centers to offer unique services that currently are difficult for smaller, independent labs to offer. Private practices of specialist physicians, such as urologists, are being acquired and integrated with centers for imaging and treatment, as well as lab testing. This move offers patients the continuum of care and convenience, as well as the opportunity to improve care.”
The Clinical Laboratory: Looking Beyond 2023
As with any prediction, not all of them may come to pass or in the way that the experts have outlined.
What is certain, however, is there will be change and evolution in clinical laboratory practices and businesses throughout the year.
Chris Wolski is chief editor of CLP.
REFERENCES
1. Blakey, G., McCloskey, C., Guthridge, J., Williams, C., Rufei Lu, P., Hayes, J., Pinkston, K., & Talbert, M. (2021). COVID-19 Pandemic Spurs Evolution of an Academic Pathology Department and Laboratory. Academic Pathology, 8. https://doi.org/10.1177/23742895211037029
2. Silva, B. (2020). Key challenges of training for lab safety and COVID-19 effects. MLO: Medical Laboratory Observer, 52(10), 16–20.
3. “Breast and Prostate Cancer Diagnoses Still Lagging During Second Full Year of COVID-19 Pandemic, Quest Diagnostics Health Trends Study Finds.” Quest Diagnostics. Oct. 11, 2022. https://newsroom.questdiagnostics.com/2022-10-11-Breast-and-Prostate-Cancer-Diagnoses-Still-Lagging-During-Second-Full-Year-of-COVID-19-Pandemic,-Quest-Diagnostics-Health-Trends-R-Study-Finds
4. BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4087 (Published 04 November 2020)
