Two Imperatives for the Future of Diagnostics: Adaptability and Digitalization to Unlock the Potential of AI

Historically, diagnostic testing has taken a one-size-fits-all approach: Doctors order tests, health professionals collect the sample, laboratorians conduct the assays, and results are sent back to the doctors. Unfortunately, this model doesn’t work for everyone. Individuals face barriers to accessing these diagnostics, ranging from geographic distance to discomfort with the current procedures. This is why, as an industry, we increasingly recognize that innovative diagnostics employ both rigorous science and adaptations that allow them to cater to individual needs. Much of our innovation now is dedicated to the patient experience and reimagining how tests are designed and delivered in different healthcare settings. 

Increasing access to diagnostics – the frontline of healthcare – is undoubtedly where the industry needs to go. But it comes with its own challenges. Over 14 billion lab tests are now ordered annually, contributing to 70% of today’s medical decisions. This incredible demand and increasing volume places added pressure on understaffed labs throughout the U.S. Digitalization is, therefore, a very important parallel innovation. It allows labs to collect and connect diverse data sources and serves as the foundation for leveraging advancements in artificial intelligence. This digital transformation, powered by advances in data, algorithms, and unprecedented computing power, can help streamline previously laborious processes while increasing speed and accuracy. It’s a necessary evolution for labs to manage the increasing volume and complexity of diagnostic tests.      

Together, adaptability and digitalization combined with AI are helping shape the future of diagnostics, providing new opportunities for lab efficiency and broader access to tests. These two very distinct trends truly work hand in hand.

Patient-friendly diagnostics to improve access

Healthcare doesn’t exist in a vacuum. When patients walk into their doctor’s office, they bring unique backgrounds and perspectives. Historically, the healthcare system met each person with a set of fixed care options. Now, there is a wider focus on examining the patient experience for opportunities for improvement, particularly within diagnostics. New, innovative testing methods are helping to overcome long-standing barriers to access, particularly in fields where disparities or stigmas exist. Personalized diagnostics can better adapt to individual differences in access, preference, and other important factors. 

This innovation can take many different forms, including non-invasive alternatives to traditional tests. While there has been a lot of excitement around tests that can screen for cancers via a simple blood draw, blood-based tests for Alzheimer’s disease (AD) are also beginning to enter the clinic. These tests have the potential to streamline a path to diagnosis that is often laden with challenges and delays. Along with cognitive assessments, an Alzheimer’s diagnosis typically involves either positron emission tomography (PET) scans at specialty clinics and/or sampling of cerebrospinal fluid (CSF) to look for the tell-tale biomarkers of AD. Due to the ongoing shortage of neurologists, wait times to access these tests are often lengthy.

This is a clear challenge. Effective diagnostic tools exist, but too few individuals can access them. Fortunately, dedicated efforts are in place to expand testing options and overcome these barriers. The first FDA clearance of a blood-based AD test, announced in May, was an exciting milestone, but it is just the tip of the iceberg when it comes to innovation. With many other blood-based biomarker assays proceeding through development, we can expect to hear and see more about these tests in 2025 and beyond. Non-invasive and highly scalable blood-based assays complement CSF tests and PET scans. With a lower barrier to access, they could help streamline diagnosis and eligibility assessments for the disease-modifying therapies (DMTs) that are now available.

In cervical cancer screening, human papillomavirus (HPV) self-collection is another excellent example of how diagnostics can adapt to meet the needs of patients who are under-screened or have never been screened before. Persistent infection with HPV is believed to cause more than 90% of all cervical cancer cases. More than half of U.S. patients diagnosed with cervical cancer have never been screened or have only been screened infrequently for HPV. Self-collection provides an accessible screening alternative to clinician collection procedures, helping to reduce barriers for individuals, such as embarrassment, history of traumatic experience, cultural concerns, and geographical distance from a healthcare provider.

HPV self-collection is an important addition to cervical cancer screening, bringing diagnostics physically closer to the patient and facilitating accurate testing for populations with specific needs and experiences. While the collection method is new, self-collection maintains the same scientific rigor to guide the highest level of patient care.

All of these examples share common benefits: increased chances of an early and accurate diagnosis, resulting in better outcomes. Patient-centric innovation and adaptability are central to delivering diagnostics that meet the patient where they are and ensure widespread access.

Managing complexity with digital solutions

The field of healthcare and diagnostics continues to march forward. On the receiving end are medical laboratories throughout the U.S., which are often grappling with staff shortages and the ongoing pressure to cut costs and maximize revenue. Here, the increasing complexity and sheer volume of diagnostic tests ordered is an added complication. How can they do more with less?

The solution is a move towards digitalization. New, integrated digital solutions can connect their entire workflow, from test ordering to analysis and delivery of lab reports. The process is streamlined and less reliant on individual staff and manual steps. Disparate data sources can be connected and structured to increase visibility and generate actionable insights. It’s an entirely new digital infrastructure that changes how our industry approaches diagnostics. We are not aiming to simply run tests and optimize throughput; we’re building a digital ecosystem that can drive operational excellence. 

For individual laboratory roles, AI is empowering teams to do their best work. For example, digital pathology software can scan tissue samples for viewing and image analysis. Algorithms for everything from risk profiling to tumor analysis can help segment patients and provide insight into which therapeutics may be most effective. Laboratorians and clinicians are still responsible for making the final call but can do so with more information at their fingertips. 

Digitizing workflows in the areas of analytics and monitoring will make a tangible difference to lab managers and point-of-care coordinators by reducing costs, increasing speed, and improving productivity, especially in areas like test turnaround times. This has direct benefits for patients and their clinicians, as they receive results quickly and initiate their treatment journey. 

Adaptable diagnostics, digitalized labs

Diagnosis is an essential inflection point in a patient’s journey, and we have a responsibility to deliver accurate and timely diagnostics that meet patients where they are while arming labs with the best possible technologies. This includes digitalization and the implementation of advanced AI to unlock new possibilities. While this kind of innovation and change can be challenging and is often a significant investment, it represents a powerful combination that can benefit individuals, healthcare professionals, and laboratories. As we expand into this new digital realm, technical collaboration across systems and companies will be critical to empowering laboratorians and ensuring their success in an exciting yet challenging new era of diagnostics. 

Photo: HASLOO, Getty Images

Antonio Vergara is the senior vice president, Core Lab and Near Patient Care at Roche Diagnostics North America and oversees the commercial functions of these business areas in the United States.

Vergara is an experienced professional in the healthcare and diagnostics sectors. His career at Roche spans 28 years, during which he has established a reputation as a high-performing leader with a strong financial background and a passion for creating a people-centric culture. Prior to his current role, Vergara held the position of President and Head of Roche Diagnostics in Latin America.

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