Danny A. Milner
Executive Director, Access to Oncology Medicines, Union for International Cancer Control, Geneva, Switzerland
Biggest challenge in pathology? Everyone knows about the threats associated with the advent of digital pathology and AI. But they aren't the real challenge. The major threat to the field of pathology today is multi-cancer early detection. This has the power to screen entire populations potentially before a cancer is detectable by routine methods. Once this is in place, functioning, and following appropriate clinical trials and studies, patients with positive signals but no obvious cancer can undergo a pan-cancer therapy for a limited period and re-test. This paradigm will remove surgeons, pathologists, and oncologists (and all of their staff) from the process and create a primary care role for the elimination of cancer. Of course that situation is BEST for patients because everyone survives, no one suffers, and cancer loses its psychological hold on society. But such disruptive innovation has a creative destruction in its wake. The challenge for the field of pathology is to embrace this eventuality and determine where quality, safety, and outcomes monitoring are ideally suited for laboratory professionals to oversee is such a new paradigm.
Exciting developments and trends? About 47 percent of the world's population does not have access to basic diagnostics. This is especially true in oncology diagnosis, where the percentage is much lower. With the advent of COVID, laboratory infrastructure spending exploded and there are now tools in place that can be used for many things in diagnostic medicine (e.g, sequencing).
But none of that technology is valid without the core pathology model of histology. So, for me, the very exciting trend is the interest and emphasis on global health and technology transfer and sharing with low- and middle-income countries (LMICs) to allow for functioning cancer care systems. This creates enormous opportunities that were simply not available before for training, secondary consultations, collaboration, research, clinical trials, and more.
Although pathology is often stated as being both a personnel- and cash-expensive specialty, the practice of pathology, when stocked, quality managed, and maintained, in LMICs is significantly less costly – with the exception of immunohistochemistry. This tool is still costly because manufacture occurs in high-income countries only. But, the current trend towards massive collection of images for foundational models in AImeans that we will have tools to predict and replace IHC directly from digitized histology very soon. With the combination of digital pathology consultation and AI biomarker prediction, LMICs will leapfrog to a modern diagnostic system without having to massively increase their workforce, infrastructure, or costs.
Controversial opinion? One issue that must be resolved in order for patients to receive the best care is financial disincentives in best practices for cancer care. In lung cancer, for example, a patient with non-small cell lung carcinoma should have molecular testing performed at the time of diagnosis to determine if they are eligible for specific targeted therapies. Although there are at least eight of these targets, many patients only get testing for the two most common. If/when a patient is negative for all of these biomarkers – or, most commonly, has the two most common ones ruled out by direct testing – they become eligible for immunooncology therapy. But here is the problem: immunooncology therapy can be procured and sold through a local oncology pharmacy but the targeted therapies are only available through specialty pharmacies through which the oncologist makes no money.
In addition, sending a patient's sample for sequencing has a cost which may or may not be reimbursed. So, we currently have a situation where an oncologist should send a patient's sample for sequencing – risking not getting reimbursed for the test – and if the result comes back positive, the oncologist will lose significant revenue.
What is the solution? It is to identify financial disincentives where laboratory professionals are involved and resolve them by creating standard practices that remain unwavering. This will massively improve patient care and outcomes and save the system considerable funds.
