Importance of extraction vessel shape in medical device testing: A GeneTox case report

GTA 2025 -- The in vitro Chromosomal Aberration Test (CAT) Assays play an instrumental role in the assessment of genotoxic potential of a new medical device. The CAT Assays identify substances that cause structural chromosomal aberrations, called clastogens, which directly cause DNA break(s). Medical devices are made using different materials and defining specific doses of the substance(s) of interest is impossible, thus their fluid extracts are prepared, making device extractions a critical factor for biological risk assessment. Extraction is performed at specific conditions/temperatures to maximize the number of extractable substances without chemically changing the extracted substances. Extraction vessels are specified as clean, inert, closed with least dead space, but their shape is not considered. We present a case report where the shape of the extraction vessel made a significant difference in our CAT Assay results.