Almac Diagnostic Services Extends Agreement with Affymetrix
February 21, 2008
New agreement covers research and diagnostics across all cancer areas
21 February 2008. Almac Diagnostic Services today announced the extension and widening of its ‘Powered by Affymetrix™’ (PbA) agreement with Affymetrix Inc. (NASDAQ: AFFX) 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 Diagnostic Services 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 Diagnostic Services.
“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 Diagnostic Services. 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 the
Powered 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.
Notes to Editor
About Almac Cancer DSATM Research Tools
The Cancer DSATM research tools are the first high density transcriptome based microarrays which focus on the transcriptome of a particular disease. These contain the most complete transcriptome information available for the disease under investigation, on a single array.
The DSATM technology has been optimised to work with both fresh frozen and formalin fixed paraffin embedded (FFPE) samples, allowing access to the vast amount of information currently available in tissue banks and enabling retrospective discovery and validation studies.
About Almac Diagnostic Services
Almac Diagnostic Services provides translational genomic based solutions for Pharma, biotech and academic customers. Almac specialises in working with fresh and formalin fixed paraffin embedded (FFPE) tissue for generation of predictive and prognostic tests, drug development, target identification and companion diagnostics.
About Almac Group
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including world leaders in the pharmaceutical and biotech sectors. The company has 2,000 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. For more information about the Almac Group, please visit www.almacgroup.com.
Affymetrix GeneChip® microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases.
Today, Affymetrix technology is used by the world’s top pharmaceutical, diagnostic and biotechnology companies, as well as leading academic, government and not-for-profit research institutes. More than 1,700 systems have been shipped around the world and more than 11,000 peer-reviewed papers have been published using the technology.
Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., Cleveland, Ohio and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit: www.affymetrix.com.
All statements in this press release that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix’ “expectations,” “beliefs,” “hopes,” “intentions,” “strategies” or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: risks and uncertainties relating to commercial success of the agreement with Almac Diagnostic Services discussed in this press release; risks of the company’s ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties related to sole-source suppliers; risks associated with past and future acquisitions; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix’ Form 10-K for the year ended December 31, 2006, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
NOTE: Affymetrix, the Affymetrix logo and GeneChip® are registered trademarks owned or used by Affymetrix Inc.
Contact: Michael Sloan
T: + 44 (0)28 3833 7575