Almac Diagnostics extends agreement with Affymetrix
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Almac Diagnostics today announced the extension and widening of its ‘Powered by Affymetrix™’ (PbA) agreement with Affymetrix Inc. for an additional 15 years. The new agreement enables Almac to develop diagnostic products utilising Affymetrix’ microarray technology for all cancer areas. Almac has chosen the Affymetrix system as the platform of choice for the development of its proprietary Cancer DSATM product line, the discovery tools behind Almac’s IVD pipeline.
Almac Diagnostics will continue to work with the U.S. Food and Drug Administration (FDA) on a 510K-approval route for its first IVD, a stage 2 colorectal cancer recurrence test being developed using the Almac Colorectal Cancer DSATM with an intended launch date in 2009. Almac is also developing IVDs in stage I lung cancer and DCIS utilizing its Lung and Breast Cancer DSATM products respectively.
“The extended PBA agreement with Affymetrix will facilitate the expansion of the Almac IVD pipeline and that of its partners to include additional prognostic and predictive tests in all cancer types. Our DSATM technology when applied to formalin fixed paraffin embedded (FFPE) tissue facilitates a rapid transition from discovery to validation, dramatically reducing the timelines for test development,” said Prof. Paul Harkin, President & Managing Director, Almac Diagnostics.
“The Cancer DSATM product line also provides an exciting new solution for our partners in pharmaceutical, biotech and academic organizations, enabling the reduction of discovery timelines, acceleration of the validation process and ultimately the delivery of clinical applications.” added Prof. Harkin.
“We are pleased to expand our relationship with Almac Diagnostics. Almac is a leader in the diagnostic field and this decision further affirms the Affymetrix system as the platform of choice for molecular diagnostic applications,” said Greg Yap, Vice President of Strategic and Commercial Development, Molecular Diagnostics at Affymetrix. “Molecular based signature assays like these will change the paradigm for future patient care and treatment by providing clinicians with a more efficient method to diagnose, classify and manage various types of cancer.”
Affymetrix is partnering with the world’s leading diagnostic companies through thePowered by Affymetrix™ program to bring about new diagnostic tests that can provide more efficient and complete methods to diagnose, classify and manage complex diseases like cancer. The Affymetrix GCS3000Dx is the only microarray instrumentation platform to receive regulatory clearance by the U.S. FDA and to be CE marked in the European Union for in-vitro diagnostic use. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its 10 PbA Partners.