Of standards and armored RNA

AUSTIN, Texas—In early December, Asuragen Inc. announcedthat it had entered into an exclusive agreement with Novartis to developworldwide 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, thiseffort is intended to aid laboratories with standardization of BCR-ABL1 RT-qPCRtesting to the International Scale.

"Our development of the BCR-ABL1 RNA IS Calibrators andsoftware tool leverages both our expertise in molecular diagnostics assaydevelopment and our proprietary Armored RNA technology," says Carlson. "We arepleased to be working with Novartis in order to develop a standardization ofBCR-ABL1 molecular testing for the entire global testing community."

Under the terms of this agreement, if Asuragen is successfulin the development efforts, it will distribute both the ARQ BCR-ABL1 IS RNACalibrators and the software reporting tools to laboratories globally.

Suchdistribution will be either directly from Asuragen or through its distributorsor both, Carlson notes.

The BCR-ABL1 RNA IS Calibrators are intended to becompatible with several widely used assays, including both commerciallyavailable and laboratory-developed tests.

In addition to facilitating the standardization of BCR-ABL1RT-qPCR results to the International Scale, Carlson says the RNA Calibratorsshould "provide unmatched internal and external assay calibration."

The software reporting tool is expected to help standardizehow BCR-ABL1 RT-qPCR results are reported according to the IS.

Carlson notes that his company's Armored RNA products ingeneral serve as excellent controls for molecular diagnostics, which is quicklybecoming a part of routine clinical laboratory testing.

More big news about Asuragen's BCR/ABL1 testing abilitiescame back in mid-July 2010, with reports that Asuragen and Life TechnologiesCorp. achieved CE-marking and commercial launch in Europe of the BCR/ABL1 QuantTest, Asuragen's clinically validated and cGMP manufactured test intended toaid clinicians in the monitoring and treatment of individuals afflicted withchronic myeloid leukemia.

Asuragen manufacturers the monitoring test, which isexclusively distributed by Life Technologies and runs on the company's AppliedBiosystems CE-marked 7500 Fast Dx Real-Time PCR Instrument.

"The BCR/ABL1 Quant Test provides several advantages over currentmethods by enabling multiplex detection of all targets in a single reaction andproviding unmatched standardization through the use of our proprietary ArmoredRNA Quant technology for external calibrators and process controls," Carlsonsays.