Of standards and armored RNA
AUSTIN, Texas—In early December, Asuragen Inc. announced that it had entered into an exclusive agreement with Novartis to develop worldwide Armored RNA Quant (ARQ) BCR-ABL1 RNA International Scale (IS) Calibrators, as well as laboratory software reporting tools.
According to Rollie Carlson, Asuragen’s president, this effort is intended to aid laboratories with standardization of BCR-ABL1 RT-qPCR testing to the International Scale.
“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,” says Carlson. “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.”
Under the terms of this agreement, if Asuragen is successful in the development efforts, it will distribute both the ARQ BCR-ABL1 IS RNA Calibrators and the software reporting tools to laboratories globally.
Such distribution will be either directly from Asuragen or through its distributors or both, Carlson notes.
The BCR-ABL1 RNA IS Calibrators are intended to be compatible with several widely used assays, including both commercially available and laboratory-developed tests.
In addition to facilitating the standardization of BCR-ABL1 RT-qPCR results to the International Scale, Carlson says the RNA Calibrators should “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.
Carlson notes that his company’s Armored RNA products in general serve as excellent controls for molecular diagnostics, which is quickly becoming a part of routine clinical laboratory testing.
More big news about Asuragen’s BCR/ABL1 testing abilities came back in mid-July 2010, with reports that Asuragen and Life Technologies Corp. achieved CE-marking and commercial launch in Europe of the BCR/ABL1 Quant Test, Asuragen’s clinically validated and cGMP manufactured test intended to aid clinicians in the monitoring and treatment of individuals afflicted with chronic myeloid leukemia.
Asuragen manufacturers the monitoring test, which is exclusively distributed by Life Technologies and runs on the company’s Applied Biosystems CE-marked 7500 Fast Dx Real-Time PCR Instrument.
“The BCR/ABL1 Quant Test provides several advantages over current methods by enabling multiplex detection of all targets in a single reaction and providing unmatched standardization through the use of our proprietary Armored RNA Quant technology for external calibrators and process controls,” Carlson says.