The College of American Pathologists released 11 new evidence-based clinical recommendations to help labs better use quantitative image analysis (QIA) in HER2 testing for breast cancer.
The first-ever guidelines put forth steps to validate QIA before implementing along with maintenance steps to assure quality and control while testing. The college recommends labs validate QIA results by comparing them to an alternative, validated method such as HER2 in-situ hybridization protocol or consensus images.
“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 M. Bui, MD, PhD, of the Moffitt Cancer Center in Tampa, Florida, in a news release. “The recommendations will aid laboratories to ensure that diagnoses are accurate and consistent, which is essential to each patient’s prognosis and treatment planning.”
A panel of pathologists and histotechnologists with expert knowledge in digital pathology, immunohistochemistry, quality management and breast pathology created the guidelines. The group reviewed more than 250 articles and took evidence from more than 65 to create the recommendations.
An early version of the guideline was published in an edition of Archives of Pathology & Laboratory Medicine.