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HERmark Breast Cancer Assay Is Now Available

July 10th, 2008 Medgadget Editors Oncology


Monogram Biosciences, Inc. out of South San Francisco is announcing availability of their assay for the detection of a particularly aggressive type of breast cancer that exhibits presence of the HER2 protein.
From a press release by the company:

ERmark 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.

Press release: Monogram Announces Commercial Availability of the HERmark(TM) Breast Cancer Assay…
Product page: HERmark…

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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