11/14/2022 0 Comments Pathology illustrated review in colorProteins and nucleic acids are routinely identified in biopsy tissues by antibody-binding or nucleic hybridization technologies such as IHC and in situ hybridization (ISH). Diagnosis of disease, in particular cancer, is based on examination of cells by microscopy and on detection of specific molecules in cells. Disease is merely the conflict of citizens of the state…” ( Virchow, 1858). Rudolf Virchow, known as the father of histopathology, wrote that the body is like a state “ …in which every cell is a citizen. The “magic” is the pathologist’s integration, interpretation and judgment of data to establish a diagnosis that is reported in the medical record, codified in journals and textbooks, or simply Tweeted. Tissue samples and data workflows converge on the mountaintop, where the pathologist’s gaze is directed in a microscope. The sage is the pathologist, who, through years of observation and discernment dispenses wisdom. The foundation of knowledge is histopathology – examination of changes in cells and tissues viewed by microscopy to diagnose disease. From its origins in the mid-19th century to today, diagnostic anatomic pathology follows a similar construct. Magic happens, wisdom is dispensed, and the seeker descends the mountain. Advice seekers climb the mountain to pose their question or dilemma. Visualize the archetype: a wise sage, sitting on a mountain, legs folded, in meditative gaze. In diverse human cultures, knowledge is disseminated by an esteemed individual who has achieved wisdom through discipline and sacrifice. Until mIF reagents, digital pathology systems including fluorescence scanners, and data pipelines are standardized, we propose that diagnostic labs will play a crucial role in driving adoption of multiplex tissue diagnostics by using retrospective data from tissue collections as a foundation for laboratory-developed test (LDT) implementation and use in prospective trials as companion diagnostics (CDx). We expand the brightfield WSI system “pixel pathway” concept to multiplex workflows, suggesting that adoption might be accelerated by data standardization centered on cell phenotypes defined by coexpression of multiple molecules.Ĭonclusion: Multiplex labeling has the potential to complement next generation sequencing in cancer diagnosis by allowing pathologists to visualize and understand every cell in a tissue biopsy slide. Adoption will also be facilitated by evidence that justifies incorporation into clinical practice, an ability to navigate regulatory pathways, and adequate health care budgets and reimbursement. Widespread implementation will require improved detection chemistry, illustrated by InSituPlex technology (Ultivue, Inc., Cambridge, MA) that allows coregistration of hematoxylin and eosin (H&E) and mIF images, greater standardization and interoperability of workflow and data pipelines to facilitate consistent interpretation by pathologists, and integration of multichannel images into digital pathology whole slide imaging (WSI) systems, including interpretation aided by artificial intelligence (AI). Results: Multiplex labeling is poised to radically transform pathologic diagnosis because it can answer questions about tissue-level biology and single-cell phenotypes that cannot be addressed with traditional IHC biomarker panels. Within the framework of assay design and testing phases, we examine the suitability of multiplex immunofluorescence (mIF) for clinical diagnostic workflows, considering its advantages and challenges to implementation. We review multiplex methods and strategies used in clinical diagnosis and in research, particularly in immuno-oncology. Methods: We review immunohistochemistry (IHC) and related assays used to localize molecules in tissues, with reference to United States regulatory and practice landscapes. Multiplex labeling is used for specific clinical situations, but there remain barriers to expanded use in anatomic pathology practice.
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