HERCULES, Calif. — December 4, 2017 — Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) today announces the launch of the QXDx BCR-ABL %IS Kit, the first CE-IVD digital PCR test that can monitor the molecular response of patients with chronic myeloid leukemia (CML) to therapy, and it does so more precisely and reliably than other available technologies.
Chronic myeloid leukemia, or CML, is characterized by the "Philadelphia chromosome," a translocation of chromosomes 9 and 22 that results in BCR-ABL gene fusion. Tyrosine kinase inhibitors can target BCR-ABL kinase activity and can transform CML into a manageable chronic disease for many patients.
The global standard of care for managing CML, measuring BCR-ABL mRNA, however, falls short of clinicians' needs. There remains significant variation between laboratories as well as within laboratories that are using existing reverse transcription quantitative PCR (RT-qPCR) methods, which are not sensitive enough to determine whether a patient can discontinue therapy without risking disease recurrence.
The QXDx BCR-ABL %IS Kit provides an absolute measure of BCR-ABL transcripts with high reproducibility, precision, and sensitivity because it uses Bio-Rad's Droplet Digital PCR (ddPCR) technology. The kit is able to detect deep molecular response values of MR 4.7 or 5.0 in 2- or 4-well formats, which exceeds typical limitations of RT-qPCR-based tests that are reliable only down to MR 4.5. Its high sensitivity permits disease remission to be assessed more confidently, so can better aid clinicians in disease management decisions.
"Bio-Rad's ddPCR system is a powerful solution for monitoring patients treated for CML," said Dr. Niels Pallisgaard, from the Department of Pathology at Zealand University Hospital in Denmark. "The increased sensitivity, precision, and reproducibility of BCR-ABL measurements without the need for standard curves, as in traditional RT-qPCR methods, lends to the rationale for the use of ddPCR in routine laboratory testing."
With its CE-IVD marking, the kit is available for diagnostic use in Europe, Hong Kong, and New Zealand. It can be used with Bio-Rad's QX200 AutoDG ddPCR Dx System or with the QX200 ddPCR Dx System. The QXDx BCR-ABL %IS Kit uses QuantaSoft Software v1.7 for data acquisition and output.
Additional benefits of the QXDx BCR-ABL %IS Kit include:
- Reproducible results — absolute quantitation eliminates the need for standard curves and minimizes variation between samples
- Scalable throughput — test from 8 to 48 samples per run to meet any clinical laboratory's throughput needs
- High specificity — detect abnormal transcripts that encode for p210 hybrid BCR-ABL protein associated with CML, but not p190, which is associated with acute lymphoblastic leukemia
Bio-Rad, QXDx, QX200, AutoDG, Droplet Digital, ddPCR, and QuantaSoft are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions.
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) develops, manufactures, and markets a broad range of innovative products and solutions for the life science research and clinical diagnostic markets. The company is renowned for its commitment to quality and customer service among university and research institutions, hospitals, public health and commercial laboratories, as well as the biotechnology, pharmaceutical, and food safety industries. Founded in 1952, Bio-Rad is based in Hercules, California, and serves more than 100,000 research and healthcare industry customers through its global network of operations. The company employs more than 8,350 people worldwide and had net sales exceeding $2 billion in 2016. For more information, please visit http://www.bio-rad.com.
This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding our development and launch of new products and our expectations regarding our products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "can," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include our ability to develop and market new or improved products, product quality and liability issues, our ability to compete effectively, and international legal and regulatory risks. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad's public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Report on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.