Eric Walk MD, FCAP

The field of pathology is rapidly moving toward a digitally enabled future where all pathologists access, view, diagnose and manage cases using whole slide images (WSIs) and artificial intelligence (AI) algorithms. As this transformation progresses, it will continue to be critical for pathologists, laboratory professionals, and other key decision makers to become fluent in the evolving language of AI and digital pathology (DP); after all, we will be charged with making informed decisions about… Show more

The field of pathology is rapidly moving toward a digitally enabled future where all pathologists access, view, diagnose and manage cases using whole slide images (WSIs) and artificial intelligence (AI) algorithms. As this transformation progresses, it will continue to be critical for pathologists, laboratory professionals, and other key decision makers to become fluent in the evolving language of AI and digital pathology (DP); after all, we will be charged with making informed decisions about which specific digital and AI pathology solutions best meet the needs of our practice environment. Show less

Programmed death ligand-1 (PD-L1) immunohistochemistry companion diagnostic assays play a crucial role as predictive markers in patients being considered for immune checkpoint inhibitor therapy. However, because of a convergence of several factors, including recognition of increased types of cancers susceptible to immunotherapy, increasing numbers of immune checkpoint inhibitors, and release of multiple PD-L1 immunohistochemistry antibodies with differing reporting systems, this complex testing… Show more

Programmed death ligand-1 (PD-L1) immunohistochemistry companion diagnostic assays play a crucial role as predictive markers in patients being considered for immune checkpoint inhibitor therapy. However, because of a convergence of several factors, including recognition of increased types of cancers susceptible to immunotherapy, increasing numbers of immune checkpoint inhibitors, and release of multiple PD-L1 immunohistochemistry antibodies with differing reporting systems, this complex testing environment has led to significant levels of confusion for pathologists and medical oncologists. Show less

Objective: To compare different NTRK testing methods to help pathologists understand test features and performance characteristics and make appropriate selections for NTRK fusion detection for their laboratory and individual patient specimens.

Cancer immunotherapy provides unprecedented rates of durable clinical benefit to late-stage cancer patients across many tumor types, but there remains a critical need for biomarkers to accurately predict clinical response. Although some cancer immunotherapy tests are associated with approved therapies and considered validated, other biomarkers are still emerging and at various states of clinical and translational exploration.

Treatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient's HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control (NordiQC) HER2 IHC programme; results were used in an economic BC treatment model.

The field of diagnostics has unprecedented opportunities to contribute to the practice of medicine in the era of targeted therapy and personalized healthcare. Rather than simply providing information regarding the presence and classification of disease, innovative molecular diagnostic tests will directly inform patient-management decisions, such as which targeted therapies to prescribe or whether a patient should be treated more aggressively. However, in order for diagnostics to deliver this… Show more

The field of diagnostics has unprecedented opportunities to contribute to the practice of medicine in the era of targeted therapy and personalized healthcare. Rather than simply providing information regarding the presence and classification of disease, innovative molecular diagnostic tests will directly inform patient-management decisions, such as which targeted therapies to prescribe or whether a patient should be treated more aggressively. However, in order for diagnostics to deliver this high level of medical value, several challenges ranging from technical, pre-analytical, developmental, regulatory, reimbursement and quality perspectives need to be overcome. This review focuses on recent developments in each of these areas that are expected to improve the power and impact of diagnostics. Show less

As personalized medicine takes hold and revolutionizes
the way we diagnose, characterize, and treat cancer, there
is a tremendous opportunity for pathologists to make major
contributions to this emerging new paradigm and to
dramatically improve the care of patients with cancer.
Some significant changes, however, need to occur within
the field of pathology for this to become a reality. Pathology,
as a field, has been occupied primarily with the diagnosis,
classification… Show more

As personalized medicine takes hold and revolutionizes
the way we diagnose, characterize, and treat cancer, there
is a tremendous opportunity for pathologists to make major
contributions to this emerging new paradigm and to
dramatically improve the care of patients with cancer.
Some significant changes, however, need to occur within
the field of pathology for this to become a reality. Pathology,
as a field, has been occupied primarily with the diagnosis,
classification, and subclassification of disease.
Certainly, pathologists also provide prognostic information
in the form of histologic grade, and in a small number
of cases, they provide information, such as HER2 status,
that is directly related to therapy. For the most part, however,
pathologists have not played an active role in driving
forward personalized medicine. Pathology, as a field,
needs to move beyond the realm of diagnosis and mere
classification/subclassification of diseases, to become the
field responsible for providing personalized medicine information. Show less