HERmark Breast Cancer Assay Commercially Available
A new diagnostic test to assess HER2 status in patients with breast cancer will be launched next week by Monogram Biosciences, Incorporated. The company issued a press release describing the impending test launch and commercialization plans.
The HERmark Breast Cancer Assay precisely evaluates HER2 total protein and HER2 homodimer levels. The test is offered through the CAP-certified clinical laboratory at Monogram and is CLIA-validated. Data indicates that this new test provides the most accurate results about HER2 status, indicating which patients are most suited to receive Herceptin therapy.
Validation studies with the HERmark test compared findings from such with immunohistochemistry, FISH, and CISH. Findings from more than 1,000 patients were considered. Importantly, the HERmark test was able to identify patients with high levels of HER2 but had been identified as HER2-negative with other tests or were identified as having low levels of HER2.
Current approaches to assess HER2 status entail semi-quantitative measures. Those evaluate HER2 status, considered an indicator of either HER2 gene amplification and HER2 protein over-expression. The HERmark test is a quantitative assessment method.
HER2 status is key information to aid clinicians in the determination of appropriate therapeutic regimens. Recent data issued by the College of American Pathologists and the American Society of Clinical Oncologists indicates that almost one-fifth of findings from standard HER2 testing is inaccurate.
July 10, 2008 Related topics: Product Launches, New Technology & Innovation, Laboratory Equipment, Diagnostic