NuGEN Awarded ISO 13485:2003 Quality Systems Certification

CEO Elizabeth Hutt announced this month that NuGEN has been awarded the International Standards Organization's 13485:2003 certification. This important certification defines standards for design, development, production, and distribution of medical and in vitro medical devices and components.

The award comes as the result of a rigorous audit of NuGEN quality systems established in 2006 to support pharmaceutical customers in meeting mandated regulatory processes.

"Our customers are among the world leaders in drug discovery and development.  Their quest to investigate mechanisms and pathologies of disease depends on products that deliver precise, consistent, and reproducible results every time," explained Hutt.  "As their partner in the discovery process, we share our customer's commitment to rigorous quality standards and have ensured our processes will continue to address their growing needs."

Roche Selects NuGEN WT-Ovation™ Technology As RNA Amplification Product for LightCycler® System

NuGEN and Roche Applied Science have entered into an agreement enabling Roche to market and sell an RNA amplification product based on NuGEN's proprietary WT-Ovation™ technology. The new product, called LightCycler® RNA Pre-Amplification Kit, is scheduled for release in the first half of 2008.

The LightCycler® RNA Pre-Amplification Kit will allow researchers to conduct whole transcriptome gene expression analysis of the most challenging and limited clinical samples, as well as those collected during years of clinical research. Accessing the biological information in small tissue biopsies, sorted cells, and laser-capture micro-dissected (LCM) samples will shed light on the causes and influences of disease, and guide researchers in their quest for understanding how genomics plays a role in disease areas such as cancer, immune system disorders, neurological diseases, and more.



Did You Miss AACR?
Check Out These Posters



Gene Expression Profiling Using RNA from Formalin-Fixed, Paraffin-Embedded (FFPE) Colon Cancer Tissue Using WT-Ovation™ FFPE System and Affymetrix GeneChip® 3' and Exon ST Arrays, as well as Agilent Whole Genome Arrays
Victor Sementchenko, Pengchin Chen, Bonnie Kwon, and Joe Don Heath NuGEN Technologies, Inc.
Abstract Number: LB-293, Poster Section: 19

A Non-invasive Genomic Assay for the Detection of Melanoma in Suspicious Pigmented Nevi
Sherman Chang, Harold Rabinovitz, Boris Bastian, Tissa Hata, Lory Walls, Tara Palmer, William Wachsman. DermTech International, Inc., San Diego, CA, Skin & Cancer Associates, Plantation, FL, UCSF, San Francisco, CA, UCSD, La Jolla, CA, DermTech International, inc., San Diego, CA.
Abstract Number:  LB-221, Poster Section:  19

Interested in how your colleagues are using NuGEN products and solutions to enable their research?  Review these recently published works:

Publications of the Month

An Erythroid Differentiation Signature Predicts Response to Lenalidomide in Myelodysplastic Syndrome
Ebert BL, Galili N, Tamayo P, Bosco J, Mak R, et al.
PLoS Medicine Vol. 5, No. 2, e35 doi:10.1371/journal.pmed.0050035