SAN DIEGO, Calif., Oct. 27, 2015 — Agena Bioscience announced today the planned commercial launch of its CE-IVD marked MassARRAY® Dx PLUS assays for gene-specific mutation testing to aid in the selection of targeted therapy regimens. Agena Bioscience will introduce the first diagnostic kits in partnership with Diatech Pharmacogenetics. The MassARRAY Dx PLUS assays improve upon existing methods on the market, enabling highly multiplexed screening of actionable targets in a single assay, thereby dramatically reducing cost and turnaround time for testing laboratories.
MassARRAY Dx PLUS assays will provide parallel analysis of the most frequently observed and actionable mutations in colon, lung, or melanoma tumors. Labs can rapidly test for the most critical mutations in KRAS, NRAS, BRAF, EGFR, and ALK genes to drive better patient treatment outcomes.
Clinical practice guidelines, such as those set forth by the European Society of Medical Oncology, necessitate screening mutations in oncogenes such as EGFR and/or KRAS for targeted treatment. As personalized treatment has evolved with the discovery of new biomarkers, as well as the advent of novel cancer drugs, such as tyrosine kinase inhibitors, the number of actionable mutations has expanded. However, the lack of a cost-effective, practical method for screening in parallel has complicated the ease of introducing new mutations into clinical testing.
The MassARRAY Dx PLUS assays intend to serve these unmet needs. The product was developed in partnership with Diatech, which built its CE-IVD marked Myriapod® system and assays for molecular diagnostics based on Agena Bioscience’s MassARRAY technology. The Myriapod system and tests have achieved significant uptake in the Italian market, supplanting conventional PCR and sequencing tests.
“The success of Diatech in Italy confirms that our MassARRAY technology provides a compelling value for routine genetic testing, and the time has come for us to enter the broader European clinical diagnostics market,” said Peter Dansky, CEO of Agena Bioscience.
“Our customers are pleased with the performance of our tests, which offer them the right content at a significant time and cost advantage over other technologies,” said Fabio Biondi, President of Diatech Pharmacogenetics, “and this is the reason for our success in gaining a large market share in Italy.”
MassARRAY Dx PLUS assays will be launched into Germany, the United Kingdom, and France. Agena Bioscience has no plans to launch the MassARRAY Dx PLUS assays in the United States.
About Diatech Pharmacogenetics
Diatech Pharmacogenetics is a unique diagnostic company in Italy focusing its research efforts on pharmacogenetics only; supporting its own research, development and sales of pharmacogenetics tests, implemented in personalized and predictive medicine, with priority focused on the most invasive therapies: anti-cancer treatments and genetic disease. Pharmacogenetics kits developed by Diatech Pharmacogenetics target personalized chemotherapy and radiotherapy cancer treatments leading to higher efficacy and reduced side effects.
Myriapod® is the in vitro diagnostic line that permits only one DNA test to identify all SNPs which could give an adverse response to the drugs normally used for a specific neoplastic pathology treatment. The kits are able to analyze tens of mutations in a single session and permit passing from a patient’s DNA to a personalized therapy choice in less than one day.
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. The MassARRAY System is intended for research use only, and not intended for use in diagnostic procedures.