Monogram Announces Commercial Availability of the HERmark(TM) Breast Ca...(n't benefitfrom the use of Herceptin as ...),Health

"We have correlated the HERmark assay with IHC, FISH and CISH results obtained in central laboratories in more than one thousand patients, and we see a high degree of concordance between the best central lab tests and HERmark," said Michael Bates, M.D., Vice President of Clinical Research at Monogram. "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. Comparisons with local lab results by IHC or FISH suggest significantly larger numbers of discordant results. We believe the HERmark Assay measures HER2 total protein and homodimer levels very accurately and will help physicians to make treatment decisions with high confidence."

HERmark will be commercialized by Monogram through its direct sales and marketing organization. "Our existing commercial organization is being supplemented with oncology-focused sales and medical affairs personnel," said William Welch, Monogram chief commercial officer. "With HERmark's availability for patient testing, our oncology team will immediately begin introducing HERmark to medical oncologists in both key centers of excellence and large community hospitals throughout the U.S."

"Today is the beginning of a new era for Monogram with the introduction of our HERmark Breast Cancer Assay for patient testing, the first product based on our VeraTag(TM) technology platform," said William Young, Monogram chief executive officer. "With HERmark, physicians now have a way to get an accurate and reliable quantitative measurement of their patients' HER2 status to help guide personalized therapy. We are looking forward to further developing this technology in order to provide the oncology community other VeraTag based assays that will provide more comprehensive and accurate information on a individual patien
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