Asuragen, Inc. Launches a Multiplex qRT-PCR Assay for the Detection of BCR/ABL1 Fusion Transcripts

AUSTIN, Texas--(BUSINESS WIRE)--Asuragen, Inc. announced today the launch of its BCR/ABL1 Quant (RUO)* kit, a research tool utilizing multiplex real-time quantitative RT-PCR to provide simultaneous detection and quantification of BCR/ABL1 fusion transcripts (b2a2, b3a2, and e1a2), ABL1 (an endogenous control), and BCR/ABL1Quant Norm (an exogenous control) in a single reaction. The kit is based on TaqMan^® technology and is compatible with ABI 7500 real-time systems or equivalent.

The BCR/ABL1 transcript arises from a specific chromosome translocation, known as the Philadelphia chromosome, and is the hallmark of chronic myeloid leukemia (CML). Fusion transcripts corresponding to BCR/ABL1 b2a2 or b3a2 are present in >95% of CML patients. About 5% of children with acute lymphoblastic leukemia (ALL) and 20-35% of adult ALL also carry t(9;22), most often e1a2. This molecular assay provides sensitive quantitation of the BCR/ABL1 transcript from RNA extracted from peripheral blood, bone marrow aspirates or cultured cells.

BCR/ABL1 Quant is a state of the art assay providing broad target coverage and dynamic range with internal and external assay calibration powered by Asuragen’s Armored RNA^® Quant™ (ARQ) Technology. The kit includes an optional exogenous internal spike in ARQ control, BCR/ABL1 Quant Norm, to assess process efficiency and 4 external calibrators consisting of a blend of precisely quantified BCR/ABL1, ABL1 and BCR/ABL1 Quant Norm ARQs mixed at different concentrations to generate 3 standard curves. The resulting PCR products are compatible with capillary electrophoresis (CE) for subsequent determination of the fusion transcripts identity (e1a2, b2a2, or b3a2) via size fractionation.

“This product is a significant step forward in the goal of providing a robust means of determining BCR/ABL1 transcript levels that can be compared from one laboratory to another utilizing Armored RNA® Quant™ (ARQ) technology,” according to Dr. Timothy Stenzel, Chief Medical Officer and Vice President of Research and Development. “Armored RNA technology has set the standard for controls in the leading molecular assays for HIV and HCV and we are looking forward to its potential adoption as the standard in molecular oncology testing,” said Matt Winkler, Ph.D., CEO and CSO, Asuragen, Inc.

About Asuragen, Inc.

Asuragen is a fully integrated diagnostic reagent company and molecular biology service provider, focused on molecular oncology and genetic diseases, with emphasis on microRNA (miRNA). Asuragen’s current diagnostic product portfolio consists of Signature Genetic Testing and Oncology Testing products as well as 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 along with a well developed business infrastructure, GLP testing services and an established cGMP manufacturing facility that allows it to span the spectrum of discovery, testing, production and commercialization. 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.

Armored^® RNA Quant™ are registered trademarks of Asuragen, Inc.

*For Research Use Only, Not For Use in Diagnostic Procedures