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A Blueprint for Blending Anatomic and Clinical Pathology

Posted Aug 04 2009 7:32pm

The continuous blending of clinical pathology and anatomic pathology will be a necessary step in the evolution of the specialty (see: Integration of Anatomic and Clinical Pathology ). However, I have never had a clear idea about how this change would take place, which is to say I was unable to predict the catalyst for the change. However, I think that I now understand what it will be -- the expanded use of tissue and serum biomarker algorithms to diagnose disease within these two subdisciplines of pathology. The germ of this idea is contained in a recent article (see: BioImagene Develops Companion Algorithms (TM) to Further Enable Personalized Medicine ). Below is an excerpt from it:

BioImagene...is advancing its goal of bridging personalized medicine and the clinical practice of pathology by providing Companion Algorithms.These specialized algorithms...aid pathologists in the quantitative assessment of specialized diagnostic tests used to determine patient suitability for specific cancer therapies. As pharmaceutical companies work to develop companion diagnostics to individualize therapy for cancer patients, Companion Algorithms further enable pathologists to correctly identify and accurately measure specific [tissue] biomarkers used to determine appropriate treatment options for patients.... BioImagene’s Companion Algorithms can be used by pathologists to aid in the interpretation of digitized images of cancer diagnostic tests including immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH)... In February 2009, BioImagene received clearance from the U.S. Food and Drug Administration (FDA) for use of one of its Companion Algorithms...for HER2/neu immunohistochemistry tests to determine their candidacy for treatment with the Genentech drug Herceptin....BioImagene offers additional Companion Algorithms for breast cancer and is committed to developing new Companion Algorithms for other companion diagnostic tests used in prostate, colon, lung and other cancers,”[said a company spokesperson].

Whole slide imaging is the enabling technology for the automated analysis of neoplastic tissues using IHC and FISH. These two types of quantitative analyses are supported by the use of algorithms such as those that BioImagene and other digital imaging vendors have developed. Put another way, surgical pathology is rapidly becoming both more automated and quantitative. This change will reinforce and support the morphological observations currently used by surgical pathologists. In a parallel fashion, IVDMIAs are sets of serum and tissue biomarkers the significance of which are interpreted using algorithms. These test sets are used within molecular diagnostics labs to generate diagnoses and predictions about the biologic behavior of neoplasms as well as other diseases.

My vision for an integrated discipline of pathology, then, is that all diseases will eventually be diagnosed using tissue and serum biomarkers interpreted by specialized algorithms. Morphological observation of tissue and cells will continue to be very important for both the diagnosis of disease and the selection of the most appropriate sets of biomarkers and algorithms to use in a particular setting. I would also suggest that pathology will grow closer to radiology such that the science and technologies of these two medical specialties will reinforce each other through integrated diagnostics.

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