The new system uses patient-specific bar coding, forensic chain of custody principles and DNA specimen provenance assignment (DSPA) testing to compare molecular genetic profile of the breast biopsy specimen with a reference sample taken via cheek swab.
Strand Diagnostics president Ken Cerney said, "Having conducted prospective DSPA testing on tens of thousands of patients since 2009, we’ve seen that approximately one in every one hundred surgical biopsies are subject to patient misidentification, mislabeling or specimen contamination."
Norma F. Pfriem Breast Care Center breast surgeon Dr Andrew Kenler said the possibility of a misidentification of a patient’s biopsy results is nothing short of catastrophic–patients are being treated for cancer that does not exist.
"In addition, potentially life-saving treatment may be delayed for the complementary patient with the false negative diagnosis," Kenler added.
"Since implementing the know error system for breast biopsies, we can be certain that we are making treatment recommendations with the most accurate information possible for our patients.
"With widespread adoption of DSPA testing, physicians can mitigate the risk of providing a patient with an inaccurate diagnosis and unnecessary treatment."
