Asuragen announced today the CE-mark and European launch of RNARetain™ 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.

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