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…
