NuGEN Technologies, Inc., a leader in nucleic acid sample preparation and Almac Diagnostics, 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 Diagnostics, explained howworking 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 DSATM 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, laser-captured 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 DSATM 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.