A New Hope; The Dawn of Computational Pathology
April 12, 2017, marked a revolutionary turning point day in medicine. The United States Food and Drug Administration (FDA) granted de novo 510(k) clearance of the first whole slide imaging (WSI) system for primary diagnosis in surgical pathology. A product abides an FDA regulation as a medical device if it fulfills in labels, promotion, and/or consumption the Federal Food, Drug, and Cosmetic Act standards (Title 21 Code of Federal Regulations part 201, [h]), yielding adherence to pre- and post-marketing regulatory purview. The intended usage will decide on the governing pathway yet protect public health.
In stark contrast to digitizing radiology initiated in 1980, digital pathology has been lethargic, with many perceiving the late regulatory field as the main barrier to its deployment. Now, such a milestone is a testament to the tenacity of The Digital Pathology Association, the strong evidence of safety, effectiveness, and noninferiority to the discordance rate of glass slides from Philips IntelliSite Pathology Solution - the first WSI solution - and, of course, an open-mindedness and forward-thinking of FDA for its implications for pathologists and patients. The first «system enables pathologists to read tissue slides digitally to make diagnoses, rather than looking directly at a tissue sample mounted on a glass slide under a conventional light microscope. » «Because the system digitizes slides that would otherwise be stored in physical files, it also provides a streamlined slide storage and retrieval system that may help make critical health information available to pathologists, other health care professionals, and patients faster. » (Alberto Gutierrez, Ph.D., 2017). Under those conditions, the least inevitable scenarios, such as an expert second opinion and on-site pathologists' hurdles, and the essential to dispatch samples—a process that might prolong for days or weeks contingent on variables like distance, sensitive item, and transportation mode—are eased.
Once again, pathology is among the complex subjects encountering global health issues, a chronic shortage of pathologists, stress/burnout, and substantial workloads, e.g., 0.1 pathologists/100k habitats in Africa. Even beyond a century, it has retained a vital function in diagnosing cancer -the 21st-century pandemic. But while pathology governs treatment decisions, patient care avenues, and oncology research, it is paradoxically the most vulnerable to inter- and intra-observer agreement matters. In short, digital pathology, virtual microscopy, or so-called “whole-slide scanning (imaging)”, is to cope with today's pathology pressure by streamlining workflow, widening collaboration and telepathology, boosting diagnostic confidence, and educational purposes, yet unsurprisingly, new horizons have emerged!
«Not only will it promote increased efficiencies and collaboration between pathologists, but it also opens a completely new dimension toward computational pathology, which aims to increase accuracies and ultimately enhance patient care. » (Russell Granzow, 2017).