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FDA Clears Asuragen's RNA Preservation Device

NEW YORK (GenomeWeb News) – Asuragen today announced that it has received US Food and Drug Administration clearance of its cGMP manufactured sample collection and cellular RNA preservation device.

The device called RNARetain was first cleared by FDA in 2007 in conjunction with Agendia's MammaPrint breast cancer test.

RNARetain is labeled for collecting, storing, and transporting fresh breast tissue specimens for subsequent RNA isolation and molecular diagnostic testing, Asuragen said. The device eliminates the need for immediate processing of the tissue samples, and eliminates the need to flash-freeze samples and to keep them frozen throughout storage and transport.

Additionally, RNARetain eliminates the need to preserve tissue in formalin, a hazardous material that is known to cross-link and degrade nucleic acids, compromising their use for molecular applications, the Austin, Texas-based molecular diagnostic firm added.

The device consists of an aqueous tissue preservation solution provided in a single-use vial for collecting, storing, and transporting breast tissue specimens.

RNARetain is the first stand-alone product based on Ambion technologies to be cleared by FDA, Asuragen and Ambion founder Matt Winkler said in a statement. Ambion was acquired by Applied Biosystems, now part of Life Technologies, in 2006, but Winkler retained the human diagnostic rights to the technologies for use by 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," Asuragen President Rollie Carlson added.

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