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.
