Asuragen Launches RNARetain?, as a CE-Marked In-Vitro Diagnostic Device

Asuragen announced today the CE-mark and European launch of RNARetainTM Pre-Analytical RNA Stabilization Solution, the Company´s

clinically validated and cGMP manufactured sample collection and RNA

stabilization solution. Based upon patented technology, RNARetain is labeled for the collection, storage, and transport of clinical human

cellular and solid tissue specimens and stabilization of intracellular

RNA within these specimens for subsequent extraction and molecular

analysis.
RNARetain was cleared by the U.S. Food and Drug Administration

(FDA) in conjunction with Agendia BV´s

MammaPrint® breast

cancer test in June 2007. "RNARetain will become a valuable tool in molecular diagnostics and future

personalized medicine applications by allowing shipment of fresh tumor

biopsies at ambient temperature, thus greatly facilitating the

logistical process of sample handling," said

Matt Winkler, CEO/CSO, Asuragen, Inc.
RNARetain infiltrates tissues and cells, precipitating nucleic

acids and proteins in situ providing powerful protection of

cellular RNA from both intracellular and extracellular ribonucleases

which would otherwise rapidly degrade the RNA in the specimen.

Ribonucleases are ubiquitous in freshly acquired samples and need to be

inactivated in order to effectively analyze the RNA composition of a

specimen. The collection of human cellular and solid tissue specimens in

RNARetain eliminates the need to immediately process these

specimens, allowing RNA extraction and molecular analysis at a later

time and/or different location. It also eliminates the need to

flash-freeze specimens, a process that involves manipulation of

potentially hazardous agents, and to keep specimens frozen throughout

storage and transport. Formalin fixation, the most common method of

clinical biopsy preservation, is both hazardous to work with and is

known to degrade RNA.
About Asuragen, Inc.
Asuragen is a fully integrated molecular diagnostics company focused on

molecular oncology and early detection of cancer with emphasis on

microRNA. Asuragen´s current diagnostic

product portfolio consists of Signature® Genetic Testing and Oncology Testing products as well as industry

leading controls and standards engineered with its patented Armored RNA® technology. Asuragen is empowered with a high level of scientific

expertise and assay development along with a well developed business

infrastructure, GLP and clinical laboratory testing services and an

established cGMP manufacturing facility that allow it to span the

spectrum of discovery, testing, production and commercialization.

Asuragen is dedicated to developing new technologies that will become

cutting edge clinical products. More information is available at the

Company´s website: www.asuragen.com.
MammaPrint® is a

registered trademark of Agendia BV.