ONCOTYPE DX

Description of Event or Problem

THE ONCOTYPE DX TEST REPORTED THIS PT AS BEING ESTROGEN RECEPTOR NEGATIVE BY THE RT-PCR METHOD. THIS MULTIVARIATE INDEX ASSAY/DEVICE IS A LAB DEVELOPED TEST. THIS PT HAD ESTROGEN RECEPTOR PERFORMED ON BOTH A CORE BIOPSY, AS WELL AS THE VERY SAME TISSUE BLOCK THAT WAS SENT FOR PERFORMANCE OF THE ONCOTYPE TEST. IN BOTH SPECIMENS, THE ESTROGEN RECEPTOR WAS POSITIVE USING FDA CLEARED TEST KITS FOR ESTROGEN RECEPTOR IMMUNOHISTOCHEMISTRY. THIS FALSE NEGATIVE RESULT CAN CAUSE CLINICAL CONFUSION AND MAY RESULT IN A PT NOT BEING TREATED, WHICH WOULD RESULT IN PREMATURE DEATH.