Agendia signs partnership agreement with Cryogene and Mist for Middle East distribution
IRVINE, CA and AMSTERDAM, 8 November 2016 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announced today a partnership agreement to distribute the company’s breast cancer recurrence assay, MammaPrint®, in the Middle East. Agendia has signed the distribution partnership agreement with Cryogene S.A.R.L., a healthcare and diagnostics business company specializing in Personalized Medicine Oncology, and its sister company Mist S.A.L.
MammaPrint is a 70-gene breast cancer recurrence assay that predicts the clinical outcome for women with early-stage breast cancer, identifying patients who can safely forego chemotherapy post-surgery and thereby sparing them from unnecessary side effects and toxicity. Currently, MammaPrint is the only FDA-cleared breast cancer prognostic test with the highest level of evidence (1A) for its clinical utility to aid correct identification of low risk patients, as demonstrated by the primary outcome of the MINDACT clinical trial. MINDACT (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy) results were published in the prestigious peer-reviewed New England Journal of Medicine (NEJM) in August 2016.
Dr. Marjolaine Baldo, Agendia’s EMEA Commercial Vice President said: “With MammaPrint® giving physicians a proven prognostic test to identify early-stage breast cancer patients who can safely forego chemotherapy, it is important to broaden access to the test to patients worldwide. Our partnership with Cryogene and Mist is an important milestone in making our validated breast cancer recurrence assay available to the medical community in the Middle East.”
Dr Rony El Khoury, Cryogene’s CEO commented: “MammaPrint® has the potential to revolutionize the way that we treat breast cancer patients in the Middle East by providing crucial additional information to enable our doctors to coordinate individual treatment plans. This agreement will assist us in providing doctors and patients with a prognostic test that they can trust, which should rapidly bring benefits to patients, doctors and local healthcare systems.”
MammaPrint is the fastest growing breast cancer recurrence assay and has already helped over 48,000 patients from approximately 50 countries around the world. First launched in 2004 in Europe, MammaPrint is now one of the only diagnostic genomic assays with both a CE mark and FDA clearance. MammaPrint will now be available in the Middle East with all patient tumor biopsy samples being analyzed in Agendia’s fully accredited Diagnostics Laboratory in The Netherlands.
MammaPrint is a FDA-cleared in vitro diagnostic test, available from FFPE sample, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine.
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint FFPE 70-gene breast cancer recurrence assay as well as BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information, visit www.agendia.com
About Cryogene S.A.R.L and Mist S.A.L
Cryogene S.A.R.L. is a privately owned Lebanon-based company with 13 years’ experience in Medical and Diagnostic services in the Middle East region. In addition to its long and professional experience in Cord Blood Banking as Smart Cells distributor in the Middle East, Cryogene S.A.R.L. expanded its activity few years ago, to specialized laboratory testing and advanced diagnosis and screening in the Women’s Health sector by collaborating with different specialized laboratories in Europe.
Through its network of gynecologists, hospitals and private clinics, Cryogene S.A.R.L. and its daughter company Mist S.A.L have been offering Pre-gestational Diagnosis and genetic panels for the diagnosis of diseases for different medical specialties. Those analyses are performed in major accredited genetic laboratories in Europe and US.
In the field of Personalized Medicine Oncology and through its partnership with OncoDNA, Cryogene sarl and its daughter company are providing novel testing in Oncology such as tumor molecular profiling and liquid biopsy studies that can bring deeper insight into a patient’s tumor allowing individualized treatment choices.
Agendia’s high quality Diagnostic service, MammaPrint, is completing Cryogene’s Portfolio, enabling physicians in the Middle East to stratify Early Breast Cancer patients who have such a good prognosis and who can safely forgo chemotherapy and identify Breast Tumor Molecular subtypes.
For more information, visit: http://www.cryogene.eu/
Dana Garbe / Daniel Gooch / Léon Melens (EU media)
+49 30 2408304-11 / +44 20 7866 7905 / +31 6 538 16 427