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New Breast Cancer Pathology Testing Guideline Published by CAP

NEW YORK (360Dx) – The College of American Pathologists today published an evidence-based clinical practice guideline to help laboratories use quantitative image analysis (QIA) in HER2 immunohistochemistry testing for breast cancer.

QIA, which is the computer algorithm-assisted detection of specific features in an image following the digitalization of a glass slide image, has been shown to improve consistency and accuracy of interpretation compared to manual scoring by pathologists. However, the lack of a clinical guideline has been a barrier to wider QIA adoption, according to CAP.

The guideline recommends steps to validate QIA before implementing it, and steps for ongoing maintenance and evaluation so that quality is controlled and assured. Additionally, it recommends that laboratories should validate their QIA results for clinical use by comparing them to an alternative, validated method, such as HER2 in situ hybridization methods, or consensus images for HER2 IHC.

"We set out to bridge the gap between technology and clinical practice with recommendations based on expert review of published literature," said project chair Marilyn Bui, a pathologist at the Moffitt Cancer Center, Tampa Bay, Florida. "The recommendations will aid laboratories to ensure that diagnoses are accurate and consistent, which is essential to each patient's prognosis and treatment planning."

The guideline was developed by an expert panel of pathologists and histotechnologists with expertise in digital pathology, immunohistochemistry, quality management and breast pathology, convened by CAP. The panel relied on evidence from more than 65 relevant articles and reviewed 250 articles to develop the guideline's 11 recommendations. The guideline development process also included an open public comment period to include comments from professional associations, individuals, feedback from the guideline advisory panel, and independent peer review from a panel of CAP members.