Asuragen Announces Collaboration on the Development of BCR-ABL1 RNA IS Calibrators and Laboratory Software Reporting Tool at ASH
AUSTIN, Texas–(BUSINESS WIRE)–Asuragen, Inc. announced today that it has entered into an exclusive agreement with Novartis to develop worldwide Armored RNA Quant® (ARQ) BCR-ABL1 RNA International Scale (IS) Calibrators and laboratory software reporting tools, intended to aid laboratories with standardization of BCR-ABL1 RT-qPCR testing to the International Scale. As part of this agreement, Asuragen will develop and, if successful, distribute the ARQ BCR-ABL1 IS RNA Calibrators and software reporting tools to laboratories globally directly or through its distributors.
The BCR-ABL1 RNA IS Calibrators are intended to be compatible with several widely used assays, including both commercially available and laboratory developed tests (LDTs). In addition to facilitating the standardization of BCR-ABL1 RT-qPCR results to the International Scale, the RNA Calibrators are also expected to provide unmatched internal and external assay calibration. The software reporting tool is expected to help standardize how BCR-ABL1 RT-qPCR results are reported according to the IS.
“Our development of the BCR-ABL1 RNA IS Calibrators and software tool leverages both our expertise in molecular diagnostics assay development and our proprietary Armored RNA® technology. We are pleased to be working with Novartis in order to develop a standardization of BCR-ABL1 molecular testing for the entire global testing community,” said Rollie Carlson, President, Asuragen, Inc.
About Asuragen
Asuragen is a fully integrated diagnostic development company and pharmaceutical services provider. The Company’s diagnostic product portfolio consists of the first-ever validated microRNA diagnostic assay for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, innovative genetic testing solutions for the fragile X mental retardation (FMR1) gene, Signature® Oncology products for the qualitative detection of gene translocations and mutations in a variety of hematological and solid tumors, RNA stabilization technologies, and industry-leading controls and standards engineered using its patented Armored RNA® technology. Asuragen is empowered with a high level of scientific expertise and assay development capabilities, CLIA and GLP testing services, and an established cGMP manufacturing facility, which allow it to span the spectrum of discovery, testing, production and commercialization. For more information, visit www.asuragen.com
