Company achieves CE-IVD mark and enters routine molecular diagnostics market
SAN DIEGO, Calif. and Hamburg, Germany, April 4, 2016 — Agena Bioscience today announced the launch of its CE-IVD marked MassARRAY® Dx products in Europe. Two targeted diagnostic panels will be sold, the MassARRAY Dx Lung Panel and the MassARRAY Dx Colon Panel, in addition to the company’s MassARRAY Dx instrumentation.
The two diagnostic panels are the first in vitro diagnostic tests marketed by Agena Bioscience in Europe, originating from its partnership with Diatech Pharmacogenetics announced in October of 2015. Diatech has gained a significant share of the cancer diagnostics market in Italy with its own MassARRAY-based tests. Additional test panels are currently in development.
With its novel MassARRAY Dx products, Agena Bioscience offers molecular pathologists a unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing. The multiplexed MassARRAY assays allow the user to concurrently analyze the relevant oncogenes and thereby reduce cost and turnaround time compared to existing methods. The two test panels support personalized treatment and improved patient care through rapid analysis of clinically actionable mutations implicated in lung and colon cancer.
Pete Dansky, Chief Executive Officer of Agena Bioscience, commented: “Our entry into the European clinical diagnostics market is a pillar of Agena’s global strategy to grow its clinical business with targeted, clinically actionable tests. The MassARRAY Dx Lung and Colon Panels will provide rapid and reliable diagnostic results to help physicians select the most effective treatments for their oncology patients.”
The MassARRAY Dx Colon Panel simultaneously analyzes over 200 mutations in the four major oncogenes involved in the pathogenesis of colorectal cancer (KRAS, BRAF, NRAS, PIK3CA), using < 40 ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue.
The MassARRAY Dx Lung Panel simultaneously analyzes over 300 mutations in 10 genes implicated in the pathogenesis of lung cancer (EGFR, KRAS, BRAF, PIK3CA, NRAS, ALK, ERBB2, DDR2, MAP2K1, and RET), using < 40ng of DNA extracted from fresh, frozen, or paraffin-embedded tissue.
The CE-IVD marked MassARRAY Dx products, consisting of the MassARRAY Dx Colon Panel, MassARRAY Dx Lung Panel, and MassARRAY Dx instrumentation (MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser RS 1000), are sold exclusively in Europe for diagnostic use, and are not available for sale in the United States.
About Agena Bioscience
Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis, and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research. In the United States, the MassARRAY System is intended for research use only, and not intended for use in diagnostic procedures.