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HERmark Assay identifies metastatic breast cancer patients who respond to Herceptin

Monogram Biosciences : 17 December, 2007  (New Product)
Monogram Biosciences has presented the results of a study detailing the HERmark Assay's ability to identify metastatic breast cancer patients who are most likely to respond to Herceptin.
The study results were presented at the San Antonio Breast Cancer Symposium. Monogram has also received confirmation from the College of Pathologists (CAP) that the HERmark assays are approved for routine patient testing in Monogram's CLIA certified clinical reference laboratory.

'The results are an important step along the way to clinical validation of HERmark, the first product based on the VeraTag technology platform,' said William Young, Monogram chief executive officer. 'In addition to the presentation of important clinical data, I am pleased to report that the HERmark assays have completed their validation process in Monogram's CLIA-certified clinical reference laboratory. 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 commercialisation of HERmark after completion of our ongoing clinical studies.'

In the study reported today, Monogram analysed 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.

Study details: Those patients with higher HER2 expression levels (that is in the upper half of the distribution for the study cohort) experienced a 59 percent objective response rate while those with lower levels of HER2 expression (that is in the lower half of the distribution) had a response rate of only 18 percent. 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 four 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.

'Current testing technologies do not provide an accurate or precise view of HER2 biology in breast cancer, classifying patients as either HER2 'positive' or HER2 'negative',' continued Young. 'At best, conventional technologies provide a semi-quantitative analysis. However, only about half of metastatic patients selected by current technologies for Herceptin treatment respond to the drug. Data is now emerging to suggest that patients who could benefit from Herceptin may be missed by currently used assays. Our HERmark studies have provided data which consistently indicate that HERmark can precisely measure HER2 expression and HER2:HER2 dimer levels in clinical FFPE samples, and that those patients with higher levels of expression have significantly better clinical outcomes than those with lower levels. These data strongly suggest that HERmark can identify patients who are likely to respond to Herceptin better than the assays currently in use.'
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