Clinical utility of scram HER-2/neu testing on the Bayer Immuno 1 (R) automated system in breast cancer

The clinical utility of automated serum HER-2/neu measurements in breast ca ncer run on the Bayer random analyzer Immune 1((R)) was analyzed in several steps: [a] The reference interval was determined for 242 normal healthy pr eand postmenopausal females. [b] The clinical specificity of serum HER-2/ne u to separate healthy controls fr om 210 patients with non-malignant breast - and non-breast diseases was calculated. [c] The clinical sensitivity of cross-sectional serum HER-2/neu values for 204 patients (pts) with stage I- IV br east cancer was established. [d] Specimens fr om 103 stage IV breast cancer pts were tested for their parallel between serial serum HER-2/neu re sults and disease course. Results: [a] The value of 13.03 ng/ml exceeded 95 % of the results from the healthy female population. Based on the mean +2 s tandard deviations value of 14.7 ng/dl, the upper limit of normal was estab lished at 15 ng/ml. [b] The specificity for benign breast diseases and othe r benign non-breast diseases was 98.0% and 94.6%, respectively [c] The corr elation of increased serum HER-2/neu levels and stage of breast cancer reve aled the best sensitivity of 40% for stage IV disease. [4] Thirty-eight (36 .9%) of 103 stage IV patients had initial HER-2/neu values > 15 ng/ml, 33 o f wham showed longitudinal HEr-2/neu concentrations which paralleled the cl inical course of the disease giving a sensitivity of 86.8%.