Asuragen Inc., a leading molecular biology diagnostic company and service provider, today announced an agreement to develop and manufacture RNA Control Kits for Affymetrix (Nasdaq:AFFX). The RNA Control Kit is intended for use with in vitro transcription (IVT) reagent kits for clinical molecular diagnostic applications that Asuragen has licensed and supplied to Affymetrix. The RNA Control Kits manufactured by Asuragen under cGMP will enable Affymetrix to deliver a complete solution to its molecular diagnostic partners. The products will be configured for use with the GeneChip® System 3000Dx v.2. This is the only available diagnostic microarray platform that has earned 510(k) clearance from the United States Food and Drug Administration and the CE mark from the European Union.
“Affymetrix offers a continuous path to discover, develop, and commercialize biomarker signature assays”
“Affymetrix offers a continuous path to discover, develop, and commercialize biomarker signature assays,” said Matt Winkler, Chief Executive Officer and Chief Scientific Officer of Asuragen. Affymetrix is partnering with the world’s leading diagnostic companies through the Powered by Affymetrix™ (PbA) Program to bring to market new diagnostic tests that employ the latest genomic discoveries. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its 11 PbA Partners. The resulting microarray-based tests will enable clinicians to provide more efficient and complete methods to diagnose, classify, and manage patients suffering from complex diseases like cancer.
Asuragen is the preeminent partner for contract development and GMP manufacturing of RNA- and DNA-based standards and controls including plasmid DNA, Armored RNA®, and capped and uncapped IVT RNA. Asuragen’s commitment to quality and innovation has helped establish its highly stable, nuclease-resistant Armored RNA® technology as the preferred positive control format for infectious disease molecular diagnostic tests. Armored RNA® is the dominant positive control technology used in HIV and HCV viral load molecular diagnostic assays worldwide. Asuragen has leveraged its capabilities and expertise in this area to also develop multiplexed IVT RNA and Armored RNA® controls for use as external and internal controls and calibrators for oncology. The utilization of well-characterized and stable controls and standards improves the reliability of test results, decreases the potential for false result reporting, and provides assurance of optimal test performance over time.
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