Agendia’s MammaPrint Receives CE Registration

AMSTERDAM, The Netherlands, November 1 /PRNewswire/ — Agendia’s MammaPrint microarray test has been registered as a Medical Device at the Dutch Healthcare Inspectorate. This registration of the microarray and the array production is in compliance with the Dutch law on medical devices enables MammaPrint to bear the CE mark.

About MammaPrint(R)

MammaPrint(R) gene expression service uses a 70-gene profile to classify breast cancer patients as ‘low’ or ‘high’ risk of developing distant metastasis in a 10-year period. MammaPrint(R) therefore offers additional information to oncologists and patients concerning the subsequent treatment plan. Several studies in renowned institutes and hospitals in Europe and the USA have demonstrated that MammaPrint(R) outperforms conventional classifying methods such as the widely used St. Gallen criteria.

Agendia is in the process of acquiring the Medical Device registration for other genetic profile-based tests, such as CupPrint. This test is intended for Cancer of Unknown Primary patients, a case that represents around 5% of all the types of cancer and for which the diagnosis and therefore, adequate treatment, is extremely difficult by conventional techniques, resulting sometimes in high rates of toxic deaths caused by chemotherapy. This test identifies the primary tumor reliably which makes the patient to be correctly treated.

About Agendia

Agendia is a world leader in gene expression analysis-based diagnostics. The company focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling. Agendia was the first to commercialize a diagnostic test – MammaPrint(R) – a prognostic marker to determine the risk assessment of breast cancer recurrence. Based in Amsterdam, the Netherlands, Agendia is a privately owned biotechnology company that, being a spin off of the Netherlands Cancer Institute, has a strong base in top-level cancer research ensuring access to the latest developments in cancer research. Next to the development of new cancer diagnostics, Agendia offers its expertise in finding new prospective gene expression profiles to companies focusing on new drug development in the area of oncology.

Agendia BV

CONTACT: Media contact: Guido Brink. Quality Manager, +31-20-512-6242guido.brink@agendia.com Agendia B.V. Slotervaart Hospital 9D, Louwesweg 6,1066EC Amsterdam, The Netherlands