Assay Determines Breast Cancer's Susceptibility to Herceptin

An assay that accurately measures breast cancer patients' HER2 status is now commercially available to physicians throughout the United States. The HER2 status is an indicator of HER2 protein over-expression or HER2 gene amplification and enables a physician to determine whether Herceptin should be prescribed for the treatment of the cancer.

Physicians currently use semi-quantitative measures to determine HER2 status. Inaccurate measurements of HER2 status can lead to inappropriate therapy selection. Guidance recently issued jointly by the American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) indicated that approximately 20% of HER2 determinations by current testing technologies might be inaccurate.

Developed by Monogram Biosciences (San Francisco, CA, USA) the new assay, HERmark, provides precise and quantitative measurements of HER2 total protein and HER2 homodimer levels. The advantages of HERmark include high sensitivity that can detect HER2 at levels from 2,500 to over 1 million receptors per cell; measurement of the drug target rather than the HER2 gene; reporting that is simple and easy to interpret and indicates a status of "positive,” "negative,” or "equivocal,” which is more accurate than conventional measurements. In addition, clinical studies have demonstrated that HERmark is a precise method for stratifying patients with metastatic breast cancer who are more likely to respond to Herceptin-containing therapy.

Michael Bates, M.D., vice president of clinical research at Monogram said, "Importantly, HERmark identifies patients with high HER2 levels but who are HER2-negative by other assays, as well as some patients with low HER2 levels but who are judged positive by conventional assays.”


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Monogram Biosciences