SOUTH SAN FRANCISCO, Calif., July 8 MonogramBiosciences, Inc. (Nasdaq: MGRM) today announced that, effective July 15, theHERmark(TM) Breast Cancer Assay will be available to physicians throughout theU.S. for assessment of HER2 status in patients with breast cancer. HERmarkprovides a precise and quantitative measurement of HER2 total protein and HER2homodimer levels and will be offered as a CLIA-validated assay throughMonogram's CAP-certified clinical laboratory.
Physicians currently use semi-quantitative measures to determine HER2status as an indicator of HER2 protein over-expression or HER2 geneamplification to determine whether or not to prescribe Herceptin(R).Inaccurate measurements of HER2 status may lead to inappropriate therapyselection. Guidance recently issued jointly by ASCO and CAP (the College ofAmerican Pathologists) indicated that approximately 20% of HER2 determinationsby current testing technologies may be inaccurate.
"HER2 targeted therapies have been proven to be critical in the treatmentof women with HER2-positive breast cancer," said Peter A. Kaufman, MD,Associate Professor of Medicine at the Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center. "Breast cancer researchers and oncologists havecome to agree that current testing methods for HER2 are not adequate.HERmark's direct quantitative measurements of HER2 total protein and HER2homodimer levels provide much needed insight as to the real HER2 status of apatient's breast cancer. This technology may allow us to more accuratelydetermine which patients will, and which won't, benefit from the use ofHerceptin as part of their overall therapy."
"We have correlated the HERmark assay with IHC, FISH and CISH resultsobtained in central laboratories in more than one thousand patients, and wesee a high degree of concordance between the best central lab tests andHERmark," said Michael Bates, M.D., Vice President of Clinical Research atMonogram. "Importantly, HERmark identifies patients with high HER2 levelsbut who are HER2-negative by other assays, as well as some patients with lowHER2 levels but who are judged positive by conventional assays. Comparisonswith local lab results by IHC or FISH suggest significantly larger numbers ofdiscordant results. We believe the HERmark Assay measures HER2 total proteinand homodimer levels very accurately and will help physicians to maketreatment decisions with high confidence."
HERmark will be commercialized by Monogram through its direct sales andmarketing organization. "Our existing commercial organization is beingsupplemented with oncology-focused sales and medical affairs personnel," saidWilliam Welch, Monogram chief commercial officer. "With HERmark'savailability for patient testing, our oncology team will immediately beginintroducing HERmark to medical oncologists in both key centers of excellenceand large community hospitals throughout the U.S."
"Today is the beginning of a new era for Monogram with the introduction ofour HERmark Breast Cancer Assay for patient testing, the first product basedon our VeraTag(TM) technology platform," said William Young, Monogram chiefexecutive officer. "With HERmark, physicians now have a way to get anaccurate and reliable quantitative measurement of their patients' HER2 statusto help guide personalized therapy. We are looking forward to furtherdeveloping this technology in order to provide the oncology community otherVeraTag based assays that will provide more comprehensive and accurateinformation on a individual patient's tumor profile."
About the HERmark Breast Cancer Assay
HERmark is a proprietary diagnostic that accurately quantifies HER2 totalprotein levels and HER2 homodimerization in patients with breast cancer.HERmark is a CLIA-validated assay that is performed exclusively in Monogram'sCAP-certified clinical reference laboratory in South San Franc