Asuragen, Inc. Achieves ISO 13485 and ISO 9001 Certification

Business Wire, Dec 14, 2006

AUSTIN, Texas -- Asuragen, Inc., today announced that it has received ISO 13485 and 9001 certification for the quality management system for its medical devices. Asuragen undertook the more rigorous medical device certification as part of its commitment to enhancing it business capabilities and expanding its product offerings into the molecular diagnostics marketplace.

"The ISO 9001/13485 certification is another important milestone for Asuragen in becoming a premier molecular diagnostics company," says Matt Winkler, CEO/CSO of Asuragen. "With our cGMP capabilities and ISO certifications, we are well positioned to implement our strategy for international expansion."

The benefits of registration to ISO 13485 include international recognition of compliance with the FDA Quality System Regulations and unique medical industry standards, facilitation of global business, and improvement of process, product, and service quality. In addition, the ISO 13485 certification satisfies a significant portion of the EU Directive requirements for marketing medical devices in Europe, a key aspect of Asuragen's business strategy.

ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. Borrowing the structure of ISO 9001:2000, ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.

About Asuragen, Inc.

Asuragen, Inc. is a newly formed company that resulted from the sale in March 2006 of the Research Products Division of Ambion, Inc. to Applied Biosystems Group (NYSE:ABI). Asuragen is comprised of two of Ambion's former divisions, Diagnostics and Services, along with the formation of a new Discovery group dedicated to developing new technologies that will become cutting edge clinical products.

Asuragen's current product portfolio consists of Signature([R]) Genetic Testing and Oncology Testing products, as well as industry leading controls and standards engineered using its patented Armored RNA([R]) Technology. Asuragen has recently formed a partnership with Digene Corporation (NASDAQ:DIGE) to market and distribute its Signature Cystic Fibrosis screening products.

Asuragen's Molecular Biology Service group is the biomarker discovery engine for the company with a strong focus around microRNA. It also offers a range of molecular biology services to biotechnology and pharmaceutical companies including microRNA Expression Profiling, Gene Expression Profiling, Custom RNA Isolation, qRT-PCR, and Bioinformatics Services to support and accelerate your research. Asuragen is one of the few service companies that can take a pharmaceutical client from biomarker discovery through diagnostic product development and cGMP manufacture of a companion diagnostic product for a new drug.

Asuragen is a fully integrated diagnostic reagent company focused on molecular oncology and early detection of cancer, with emphasis on microRNAs. Comprised of over 100 employees spun out of Ambion, Asuragen is empowered with not only a high level of scientific expertise, but also assay development, business infrastructure and an established cGMP manufacturing facility that allow it to span the spectrum of discovery, production and commercialization. Asuragen is an Authorized Affymetrix Service Provider.

For more information, visit www.asuragen.com.