Laboratories looking to expand their services and impact can leverage cutting-edge technologies designed to enhance the quality and efficiency of treatment decisions, as well as improve patient access to care.

Companion diagnostics, polygenic risk scores, and multicancer early detection tests are reshaping the landscape by improving the value of high-cost drugs, enabling preventative approaches, and reducing the risks of late diagnosis. In addition to these innovations, digital pathology and at-home testing stand out as two key areas with substantial potential for growth.

In its simplest form, digital pathology is the transformation of glass slides into digitized formats. Today, digital pathology is moving beyond research applications and into the realm of clinical care. This transition creates digital assets that not only increase collective medical knowledge, but also elevate the quality of diagnostics, broaden consultation capabilities, and streamline diagnostic workflows.

The advantages of implementing digital pathology are multifold. By digitizing slides, laboratories can ease workforce constraints and mitigate burnout by improving overall efficiency. This technology allows lab staff to redirect their attention to more complex and intellectually stimulating tasks, while also enabling pathologists to work remotely, further enhancing job satisfaction and productivity. Additionally, digital pathology can lead to reduced turnaround times for diagnoses, directly improving patient care while simultaneously increasing the profitability of laboratory operations through enhanced throughput and efficiency.

However, adopting digital pathology comes with its own set of challenges. One significant hurdle is the implementation of appropriate coding systems, along with the need for interoperability between digital pathology systems and existing healthcare IT infrastructure.

“The challenge is the technology is moving from being nascent to more widely adopted, but it’s still a steep investment financially because digital pathology, as it is today, is a substantial operational lift,” Dr. Morice said.

The lack of reimbursement pathways specific to digital pathology and stringent FDA approval requirements also pose financial and regulatory challenges. To address these, the American Medical Association (AMA) is creating new digital pathology Category III add-on codes. These codes are not currently linked to fee codes and are aimed at accounting for the clinical staff work required to digitize glass microscope slides for primary diagnosis.

These codes are crucial because they not only measure the adoption rates of digital pathology, but also have the potential to be used for reimbursement in the future, thereby incentivizing the transition.

The widespread use of at-home, point-of-care COVID-19 PCR tests has laid the groundwork for out-of-lab testing. This use has created an infrastructure and public familiarity with conducting lab tests outside conventional settings.

While there were initial concerns about the quality of these tests, experts like Dr. Morice anticipate that these issues will diminish as we move further away from the pandemic and as the tests evolve and improve. The financial and social implications of at-home testing, both domestically and globally, are also factors that laboratories must consider as they adapt to this new landscape.

Furthermore, the increasing use of wearable devices has heightened public interest in personal health data, leading to a greater willingness to engage in at-home testing. This technological empowerment enables patients to monitor their health more proactively and contributes to the demand for at-home testing solutions.

Another market force supporting the rise of testing outside the traditional lab setting is the site-of-care shift. Healthcare providers are increasingly operating in ambulatory settings, which necessitates quick lab results that can be obtained outside traditional hospital or laboratory environments. This shift is complemented by changing patient preferences, especially among younger generations who prioritize convenience and direct access to health data, often preferring to make informed health decisions independently of clinicians.

Dr. Morice predicts, “I think clearly for infectious disease testing we’re going to see more and more use of direct-to-consumer as well as at-home or ‘point-of-need’ testing.” He also identifies chronic disease management as an area where at-home testing could significantly impact patient convenience and healthcare resource utilization.

Lab market leaders are at a point where embracing new technologies, like digital pathology and at-home testing, is crucial to meet the changing demands of healthcare. Leveraging these advancements will be essential for labs to enhance diagnostic accuracy, efficiency, and patient accessibility. Strategic adoption and integration of these innovations will position labs to effectively navigate the expanding market and continue delivering quality care.

Mayo Clinic Laboratories, the global leader in turning test results into clinical answers, provides advanced testing and pathology services for 3,400 healthcare organizations in partnership with Mayo Clinic's Department of Laboratory Medicine and Pathology. Mayo Clinic Laboratories offers more than 4,400 tests and pathology services and performs more than 26 million tests annually.

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