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.

< | >