Monogram Announces Commercial Availability of the HERmark(TM) Breast Ca...(t's tumor profile. About the HERmark...),Health

About the HERmark Breast Cancer Assay

HERmark is a proprietary diagnostic that accurately quantifies HER2 total protein levels and HER2 homodimerization in patients with breast cancer. HERmark is a CLIA-validated assay that is performed exclusively in Monogram's CAP-certified clinical reference laboratory in South San Francisco. Robust, accurate, sensitive and reproducible measurements of HER2 status are reported to physicians with a turnaround time of 7 days.

With the accurate measurements provided by HERmark, it is expected that as many as 15-20% of patients determined by conventional technologies to be HER2- negative would be reclassified by HERmark.

Key advantages of the HERmark Breast Cancer Assay include:

-- HERmark is highly sensitive and can detect HER2 at levels from 2,500 to over 1 million receptors per cell -- 7 to 10 times more sensitive than IHC.

-- HERmark provides a better measure of HER2 status by measuring the drug target -- the HER2 protein and HER2 homodimers -- rather than the HER2 gene.

-- The HERmark report is simple to interpret and provides a specific quantitative measure of HER2 expression, a HER2 status of "positive", "negative" or "equivocal" and indicates, relative to conventional measurements, how positive or how negative the patient is.

-- Clinical studies demonstrate that HERmark is an accurate method for stratifying patients with metastatic breast cancer who are more likely to respond to Herceptin-containing therapy.

Assay measurements: Physicians ordering HERmark receive a report indicating a specific quantitative measurement of the levels of HER2 total protein and HER2 homodimer, together with a comparison of where the patient's level of HER2 total protein falls within ranges of HERmark measurements that have been previously correlated in over 1,000 patients with HER2-positive and HER2-negative status by central laboratory FISH and IHC assessments. Th
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