ONCOTYPE DX MULTIVARIATE INDEX

Description of Event or Problem

THIS CASE IS UNEQUIVOCALLY AMPLIFIED FOR THE HER2 GENE BY THE FDA APPROVED VYSIS PROBE FISH KIT. THE ONCOTYPE RT-PCR TEST/DEVICE, A LABORATORY-DEVELOPED, MULTIVARIATE INDEX ASSAY, REPORTS AN EQUIVOCAL HER2 RESULT FOR THIS PT, WHICH IMPLIES TWO POTENTIALLY HARMFUL ISSUES TO THE PT, WHO IS A CANDIDATE FOR HER2 TARGETED THERAPY ACCORDING TO THE AMPLIFIED FISH RESULT: IT CLOUDS THE CLINICIAN'S JUDGEMENT ABOUT WHETHER TO GIVE HER2 THERAPY, AND RAISES SERIOUS QUESTIONS ABOUT THE ROBUSTNESS OF THE OTHER 15 GENE COMPONENTS OF THE ONCOTYPE TEST, AND HENCE, THE RECURRENCE SCORE, WHICH IS THE CORE RESULT OF THE ONCOTYPE TEST. IF A CLINICIAN CHOOSES NOT TO TREAT THIS PT BASED ON THE ONCOTYPE HER2 RESULT, THE STANDARD OF CARE WILL NOT BE MET, AND LITIGATION BECOMES A SERIOUS ISSUE FOR THIS CASE.