Optimizing cytology and small biopsy specimen processing for ancillary studies: recommendations from the American...

Clinically acquired cytopathology and small biopsy specimens provide essential diagnostic and predictive biomarker information that underlies precision medicine and patient care decisions. Biomarker testing using immunochemistry, in situ hybridization, and molecular analysis is routinely used to inform therapeutic decisions and monitor therapy. Cytopathology and small biopsy specimen collection, handling, and processing vary across different practices and are frequently determined by individual laboratory preference. Thus, clinical specimens are subject to different preanalytical variables that can impact downstream nucleic acid quality and protein antigenicity, compromising the reliability of the ancillary testing results.

Based on a recent survey by the American Society of Cytopathology there is wide variation in current practices for specimen collection and processing, reflecting a lack of consensus and standardization among cytopathology laboratories. To address this need, the American Society of Cytopathology established a special task force comprising 18 members with expertise and/or interest in ancillary studies in cytopathology and small biopsy specimens.

The task force conducted a survey of existing practices in cytopathology laboratories. A scoping review was performed to identify published literature for relevant evidence focusing on specific areas of interest. The existing literature on preanalytical variables in small specimens and their impact on ancillary studies were reviewed and data were compiled to draft best practice recommendations.

The task force has developed these evidence-based best practice recommendations for optimizing and standardizing preanalytical variables in small specimens to ensure quality and reliability of ancillary studies.