ONCOTYPE DX MULTIVARIATE INDEX

Description of Event or Problem

THE FDA APPROVED VYSIS FISH HER2 PROBE KIT DEMONSTRATED AN EQUIVOCAL RANGE HER2 TEST RESULT FOR THIS PT, BUT THE ONCOTYPE TEST FOR HER2 WAS NEGATIVE. THIS IS A SERIOUS TEST DISCREPANCY THAT CAN RESULT IN A PT WHO IS ELIGIBLE FOR TARGETED THERAPY WITH THIS RESULT, (WHICH IS CONSIDERED TO BE A POSITIVE RESULT- NOT GETTING TARGETED THERAPY BECAUSE OF THE ERRONEOUS FALSE ONCOTYPE RT-PCR HER2 RESULT). THE TEST DISCREPANCIES MAY CLOUD CLINICAL JUDGMENT. 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. IN OUR EXPERIENCE, THE HER2 COMPONENT OF THE ONCOTYPE DX TEST MISSES 100% OF HER2 EQUIVOCAL CASES ASSAYED BY THE FDA APPROVED VYSIS PROBES.