FDA clears Asuragen’s RNARetain® Pre-analytical RNA Stabilization Device
Austin, Texas – March 22, 2012. 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.
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.
Rollie Carlson, Ph.D.
2150 Woodward St., Suite 100
Austin, TX 78744
F: 512.681.5201 www.asuragen.com
RNAlater® and Ambion® are registered trademarks of Ambion, Inc. MammaPrint® is a registered trademark of Agendia BV Corporation