Strand Diagnostics, LLC, maker of the Know Error system for prostate biopsies, announced a new system designed to protect breast biopsy patients from inaccurate diagnosis due to misidentification of biopsy samples.
The process of collecting and evaluating biopsy specimens involves nearly 20 steps and several medical professionals working in different locations. The risk of patient misidentification, specimen transposition or foreign cell contamination occurring in clinical or anatomical pathology is an ongoing concern. If left undetected, these mistakes can lead to misdiagnoses and adverse patient outcomes.
The Know Error system uses patient-specific bar coding and forensic chain-of-custody principles to reduce errors and DNA testing (also known as DNA Specimen Provenance Assignment or "DSPA" testing) for identifying errors before adverse patient outcomes occur. The DSPA test verifies patient identity at the molecular level by comparing genetic profiles obtained from the patient's biopsy tissues and a DNA reference sample, taken via cheek swab at the time of the biopsy procedure.
Currently, the test is available at breast centers in select areas including The Norma F. Pfriem Breast Care Center, affiliated with the Yale New Haven Health System in Bridgeport, Conn. and the Center for Breast Care, Inc.