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.
Contact:
Asuragen, Inc., Austin Lori Brisbin, 512-681-5200 Director of Marketing lbrisbin@asuragen.com
Source: Asuragen, Inc.
