Monogram Announces Commercial Availability of the HERmark™ Breast Cancer Assay
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Monogram Biosciences, Inc. has announced that, effective July 15, the HERmark™ Breast Cancer Assay will be available to physicians throughout the U.S. for assessment of HER2 status in patients with breast cancer.
HERmark provides a precise and quantitative measurement of HER2 total protein and HER2 homodimer levels and will be offered as a CLIA-validated assay through Monogram's CAP-certified clinical laboratory.
Physicians currently use semi-quantitative measures to determine HER2 status as an indicator of HER2 protein over-expression or HER2 gene amplification to determine whether or not to prescribe Herceptin®. Inaccurate measurements of HER2 status may lead to inappropriate therapy selection.
Guidance recently issued jointly by ASCO and CAP (the College of American Pathologists) indicated that approximately 20% of HER2 determinations by current testing technologies may be inaccurate.
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."
