Monogram’s diagnostic assay found effective in cancer study

In the study, Monogram analyzed tissue samples from patients with metastatic breast cancer who were treated with Herceptin, having been selected for such treatment by centralized IHC testing. While current testing methods identified all these patients as being appropriate for Herceptin treatment, Monogram’s HERmark assay was able to distinguish separate sub-populations of patients with different clinical outcomes.

Those patients with higher HER2 expression levels (in the upper half of the distribution for the study cohort) experienced a 59% objective response rate while those with lower levels of HER2 expression (in the lower half of the distribution) had a response rate of only 18%. Additional analyses revealed that patients with higher HER2 expression values had a median time-to-progression of 12.8 months while those in the lower half of the distribution had a median time-to-progression of only 4 months. This result was statistically significant (p = 0.01). Finally, multivariate Cox proportional hazards models identified HER2 expression (HR = 0.16, p < 0.001) and HER2:HER2 dimer levels (HR = 0.32, p < 0.001) as measured by HERmark as being statistically significant predictors of time-to-progression. William Young, CEO of Monogram, said: "The establishment of solid technical validation data and the ability to perform the assays under high-throughput, well controlled conditions will provide a strong basis for commercialization of HERmark after completion of our ongoing clinical studies."