FDA clears Asuragen’s RNARetain® Pre-analytical RNA Stabilization Device
Austin, Texas – Asuragen, Inc. announced today the FDA clearance of RNARetain®, the
Company’s clinically validated and cGMP manufactured sample collection and cellular RNA preservation device.
Based upon patented technology, RNARetain is labeled for the collection, storage, and transportation of fresh breast
tissue specimens for subsequent RNA isolation and further molecular diagnostic testing. The cGMP formulation of the
RNARetain solution is based upon the same technology as the widely used research reagent RNAlater®. The
RNAlater® technology is referenced in over 1,500 peer-reviewed publications worldwide demonstrating the
technology for preservation and stabilization of intracellular nucleic acids in over 30 different tissue specimen types
and multiple cellular specimen types.
“RNARetain is the first standalone FDA cleared product based upon Ambion technologies that were part of the sale of
Ambion to Applied Biosystems in 2006. When I sold Ambion to Applied Biosystems, I believed that those existing
technologies would provide cutting edge diagnostic applications so I retained the human diagnostic rights to those
technologies for use by Asuragen,” said Matt Winkler, Ph.D., the founder of Ambion and Asuragen. “RNARetain has
proven to be a valuable tool in molecular diagnostics and holds promise for emerging personalized medicine
applications by allowing shipment of fresh tumor biopsies at ambient temperature, thus simplifying sample handling,”
said Rollie Carlson, Ph.D., President, Asuragen, Inc.
The utility of the RNARetain solution is to maintain high quality cellular RNA for downstream molecular testing. The
collection of fresh breast tissue specimens into the RNARetain device eliminates the need to immediately process
these specimens, enabling RNA extraction and molecular testing at a later time and/or transport to a different
location. RNARetain eliminates the need to flash-freeze specimens and to keep specimens frozen throughout storage
and transport, a process that can be cumbersome and costly. It also eliminates the need for preserving tissue in
formalin, the most common method of clinical tissue preservation that is also a hazardous material known to crosslink
and degrade the nucleic acids rendering them less suitable for specific downstream molecular applications.
The RNARetain device consists of an aqueous tissue preservation solution that is provided in a single-use vial for the
collection, storage, and transportation of breast tissue specimens. The ability of the solution to preserve fresh tissue
and cellular nucleic acids is due to its rapid permeation protecting against nuclease degradation.
RNARetain was first cleared by the FDA in conjunction with Agendia BV’s MammaPrint® breast cancer test in June
2007.
About Asuragen
Asuragen is a fully integrated molecular diagnostic company and pharmaceutical services provider. Asuragen is
empowered with a high level of expertise from its Ambion heritage to provide science driven solutions for novel assay
development, CLIA and GLP testing services, which, combined with established cGMP manufacturing capabilities,
allow it to span the spectrum of discovery, production and commercialization for novel personalized tests and
companion diagnostics. The Company’s product portfolio consists of the first-ever validated microRNA diagnostic test
for pancreatic cancer, multiplex quantitative RNA-based assays, break-through solutions for the detection of the
fragile X mental retardation gene (FMR1), Signature® Oncology products for the qualitative detection of gene
translocations and mutations, cGMP RNA tissue stabilization based upon RNALater® technology, and industryleading
controls and standards engineered using its patented Armored RNA® technology. In addition, Asuragen
offers a full range of contract manufacturing services for high quality QSR compliant reagents from plasmid DNA to in
vitro synthesized RNA and complex assays for IVD cleared platforms. 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.

