Asuragen, Inc. announced today that it has granted BD (Becton, Dickinson and Company), a global medical technology company, non-exclusive worldwide rights to incorporate Armored RNA® technology into its in vitro molecular diagnostics products. Under the terms of the Agreement, Asuragen will develop and supply reagents for BD Diagnostics in Asuragen's cGMP manufacturing facility. Additional terms were not disclosed.
Armored RNA® is a franchise technology jointly invented and developed by Asuragen and Cenetron Diagnostics for creating RNA and DNA standards for molecular diagnostic assays. Armored RNA has been incorporated into most HIV and HCV commercially available diagnostic assays that measure viral load and consequently is the leading internal control for infectious disease molecular diagnostic IVD assays. The Armored RNA technology encapsulates RNA standards in a protective protein coat, assuring their integrity during long-term storage and "armors" the RNA standard against the hazards of nucleases in patient samples. RNA standards are essential to quantitative molecular diagnostic assays, and maintaining their integrity is crucial to obtaining accurate, reliable results. Asuragen recently released Armored RNA Quant®, the next generation of quantitative standards. Armored RNA Quant® contains a precisely quantified copy number of a specific target and is referenced to a National Institute of Standards & Technology (NIST) traceable phosphate standard. Armored RNA Quant® can be used to construct standard curves for quantitation and as an internal quantitative sample calibrator for infectious disease and oncology testing. Asuragen has been introducing the technology into the oncology market and is developing it as an international inter-laboratory control standard for minimal residual disease testing.
Dr. Matt Winkler, CEO of Asuragen, said, "We're pleased that yet another worldwide leader in molecular diagnostics has chosen Armored RNA® technology for its in vitro molecular diagnostic kits. Armored RNA controls, due to the nature of their reliability and integrity, have become the industry standard in a wide range of diagnostic tests."
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, breakthrough solutions for the detection of the fragile X mental retardation gene (FMR1), Signature® Oncology products for the qualitative detection of gene translocations and mutations, RNA Retain®, an FDA 510(k)-cleared RNA tissue stabilization solution based upon RNAlater® technology, and industry-leading 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., 512-681-5200
President and COO