Almac Selects NuGEN Ovation® Systems to Broaden Gene Expression

Choice Enables Reliable Results from Valuable, Irreplaceable Clinical Samples

San Carlos, Calif. and Craigavon, United Kingdom. NuGEN Technologies, Inc., a leader in nucleic acid sample preparation and Almac Diagnostic Services, provider of translational genomics-based solutions, announced today that Almac has added NuGEN Ovation® Systems to its gene expression profiling services, to address the challenges of analyzing valuable, irreplaceable clinical samples. In addition, Almac has also chosen to use Ovation Systems in its own development of genomics-based diagnostic tests.

Dr. Paul Harkin, President and Managing Director of Almac Diagnostic Services, explained how working with formalin-fixed, paraffin-embedded (FFPE) tissue samples is the foundation of Almac’s approach to the development of diagnostic tests. The Single Primer Isothermal Amplification (SPIA®) technology from NuGEN coupled with Almac Cancer DSA™ microarray platform offers a unique solution to working with this degraded material.

Almac has built a pipeline of genomics-based prognostic tests that include a prognostic test for stage II colorectal cancer and a prognostic test for stage I lung cancer. In addition, Almac also has companion diagnostics in development with their pharma and biotech partners. Ovation Systems will be utilized to support the development of both types of tests.

The family of Ovation RNA amplification and labeling products from NuGEN enables sensitive and robust gene expression profiling from small or degraded samples, such as FFPE tissues, whole blood, tissue biopsies, lasercaptured micro-dissected cells, and sorted cells. Since Ovation Systems are platform-independent, researchers may conduct downstream analyses using their preferred gene expression platform.

“The combined power of NuGEN Ovation Systems and Almac Cancer DSA™ microarray platform enables Almac to quickly and easily deliver reliable results from precious clinical samples. In addition, Almac’s choice of using Ovation Systems in its own clinical and diagnostic applications is testament to their confidence in the SPIA technology,” said Dr. Sue Pandey, NuGEN vice president of field operations. Pandey also noted that NuGEN worked diligently to achieve ISO 13485:2003 certification in early 2008 for its quality management systems, which is particularly important for supporting customers in meeting mandated regulatory requirements in some of the clinical studies.

Almac will initially offer Ovation Systems for its RNA amplification and target preparation services for FFPE and whole blood samples using the following established workflows:

• WT-Ovation™ FFPE Solution: A complete target preparation solution that enables global gene expression analysis of vast archives of degraded RNA derived from FFPE samples with as little as 50 ng of total RNA.
• Ovation® Whole Blood Solution: A target preparation solution that enables global gene expression analysis from 20 ng of whole blood RNA without the need for globin reduction procedures.

Customers may immediately engage Almac for gene expression analysis and test development using NuGEN products. For pricing and availability of Almac services using NuGEN Ovation Systems, contact Almac at:

For European Enquiries

19 Seagoe Industrial Estate

Craigavon

B63 5QD

United Kingdom

T: +44 (0) 28 3833 7575

F: +44 (0) 28 3839 8676

For North American Enquiries

801-1 Capitola Drive

Durham, NC27713

T: +1 (919) 294 0230

F: +1 (919) 544 8420

About NuGEN

NuGEN Technologies, Inc. based in San Carlos, CA, is focused on the development and commercialization of sensitive, rapid, and high-throughput amplification and sample preparation systems to enable the comprehensive analysis and discovery of biological mechanisms, cellular responses, and disease pathologies.

About Almac Diagnostic Services

Almac Diagnostic Services provides translational genomic based solutions for pharma, biotech and academia. Almac specializes in working with fresh and 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, product development, clinical trial supply and technology (IVRS/Web/EDC), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

For more information about the Almac Group, please visit almacgroup.com

NuGEN, Ovation, SPIA and Ribo-SPIA are registered trademarks of NuGEN Technologies, Inc. WT-Ovation, FLOvation, and Imagine More From Less are trademarks or service marks of NuGEN Technologies, Inc. Almac Diagnostic Services DSA and Almac Cancer DSA are all trademarks of Almac Diagnostic Services Limited. All other marks are the property of their respective owners.