-- Commercial introduction in July of HERmark for assessment of HER2 status in patients with breast cancer -- providing a precise and quantitative measurement of HER2 total protein and HER2 homodimer levels by a CLIA-validated assay through Monogram's CAP-certified clinical laboratory.
-- Establishment of initial sales organization to introduce HERmark to the oncology community.
-- Introduction at ASCO of a Collaborative Biomarker Study, designed to (i) compare conventional IHC and FISH methods of HER2 testing with the quantitative measurements of HER2 total protein and HER2 homodimers provided by HERmark, and (ii) to describe the expression/co-expression profiles identified by Monogram's HER1 and HER3 Total Protein Assays along with HER2 total protein and homodimer levels identified by HERmark to facilitate analyses of how such measurements may correlate with certain laboratory and clinical parameters, including disease progression.
"Current technologies -- IHC, FISH and CISH -- are well recognized by breast cancer researchers and oncologists as being inadequate for the accurate assessment of HER2 status," continued Young. "This is the important clinical need that HERmark addresses by providing accurate and quantitative measurements of the drug target."
Physicians currently use these semi-quantitative technologies to determine HER2 status and decide whether or not to prescribe Herceptin(R). Inaccurate measurements of HER2 may lead to inappropriate therapy selection. Guidance recently issued jointly by ASCO and CAP (the College of American Pathologists) indicated that approximately 20% of HER2 determinations conducted in local laboratories by current testing technologies may be inaccurate.
"We have correlated the HERmark as
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