HUNTINGTON BEACH, California and AMSTERDAM, December 13 Dr. Michael Knauer from the Netherlands Cancer Institute today announced datauncovering a substantial group of traditionally miscategorized low risk HER2+patients. Agendia's highly accurate breast cancer tumor recurrence test,MammaPrint(R), was used to differentiate between patients at high and lowrisk for recurrence.
HER2+ patients are commonly identified as high risk, yet MammaPrint wasable to identify a low risk subgroup of HER2+ patients, who subsequentlyexperienced a 10 year disease-free survival of close to 90 percent even inthe absence of (neo)adjuvant trastuzumab (Herceptin(R)) and chemotherapy.Additionally, in a subgroup of highly endocrine responsive HER2/NEU positivepatients, MammaPrint(R) low risk patients had no relapse.
The results were presented by Dr. Michael Knauer during the 2008 SanAntonio Breast Cancer Symposium (SABCS). In the study population of 169 HER2+patients MammaPrint(R) classified 16 percent of patients as having a goodprognosis signature with a 10-year distant disease-free survival (DDFS) of 89percent, compared to 84 percent of patients classified as having a poorprognosis signature with a DDFS of 64 percent.
MammaPrint(R)'s robustness is underscored by the 70 gene panel unique tothe test and a resulting gene profile that covers all molecular pathwaysassociated with breast cancer. HER2/NEU-overexpression is observed in 15-20percent of invasive breast cancers and is widely considered to be a negativeprognostic factor. As a result, current treatment guidelines classify allHER2-positive breast cancer patients at high risk of relapse, and recommendtrastuzumab and chemotherapy.
MammaPrint(R) accurately identified a subgroup of patients with a goodclinical outcome in HER2+ early breast cancer. These patients will be furtherstudied in the ongoing MINDACT-trial (Microarray for Node-negative and 1-3positive node Disease may Avoid ChemoTherapy) to determine the prospects ofwithholding chemotherapy and/or trastuzumab in HER2+, MammaPrint(R) low riskpatients.
MammaPrint(R) is the first 'in vitro diagnostic multivariate index assay'(IVDMIA) cleared by the U.S. Food and Drug Administration (FDA). FDAclearance requires clinical and analytical validation and reporting systemsto ensure patient safety issues are addressed. Highly accurate, MammaPrint(R)identifies patients with early metastasis--those patients who are likely todevelop metastases within five years following surgery. Several authoritativestudies have shown that chemotherapy particularly reduces early metastasisrisk. In planning treatment, the MammaPrint(R) test result provides a doctorwith a clear rationale to assess the benefit of adjuvant chemotherapy inaddition to other clinical information and pathology tests.
All MammaPrint(R) tests are conducted in Agendia's CLIA-certified servicelaboratory. All other breast cancer recurrence assays currently marketed havenot been subject to the rigorous FDA clearance process.
Agendia is at the forefront of the personalized medicine revolution,striving to bring more effective, individualized treatments within reach ofpatients. Building on a cutting edge genomics platform for tumor geneexpression profiling, the company's tests aim to help physicians moreaccurately tailor cancer treatments. The company markets four products, withseveral new genomic tests under development. In addition, Agendiacollaborates with pharmaceutical companies to develop highly effectivepersonalized drugs in the area of oncology. Agendia is based in HuntingtonBeach, California, and in Amsterdam, The Netherlands. For more informationplease visit http://www.agendia.com.
SOURCE Agendia BV