Asuragen Obtains CE Mark of QuantideX® qPCR BCR-ABL Kits on Roche Diagnostics cobas z 480 Analyzer

Asuragen, Inc., a global molecular diagnostics product company changing the way patients are treated in genetics and oncology by bringing complex molecular tests to hospital and reference labs, today announced that it has expanded its CE mark of the QuantideX^® qPCR BCR-ABL IS Kit and QuantideX^® qPCR BCR-ABL minor Kit to include clinical use on the Roche Diagnostics cobas z 480 Analyzer. The exquisite sensitivity and precision of the assays support clinicians in the rapidly evolving European clinical practice of therapy cessation for long-term responders on tyrosine kinase inhibitor (TKI) therapies. The available platforms, which also include the Applied Biosystems^® 7500 Fast Dx Real-Time PCR instrument, improve the reach of the portfolio in Europe and Latin America.

“As a global solutions provider, we are committed to ensuring that our best-in-class CML monitoring assays are widely available to deliver powerful answers that can impact patient decisions,” said Matthew McManus, M.D., Ph.D., president and chief executive officer of Asuragen. “Making our BCR-ABL portfolio compatible with the 7500 Fast Dx and cobas z 480 platforms will help ensure that we can serve even more patients around the world.”

About the QuantideX ^® qPCR BCR-ABL Portfolio

The QuantideX^® qPCR BCR-ABL portfolio provides laboratories with robust, reliable and comprehensive solutions to accurately and sensitively monitor patients with chronic myeloid leukemia (CML) on TKI therapy. The portfolio includes:

• QuantideX^® qPCR BCR-ABL IS Kit -- for detecting and quantifying major (e13a2, e14a2) BCR-ABL1 fusion transcripts. Its software objectively and automatically reports results on the International Scale via a four-point calibrator system, while the CE marked product also features ABL copy number reporting to ensure alignment to European consensus guidelines. It is also cleared by the U.S. Food and Drug Administration for monitoring BCR-ABL levels in CML patients irrespective of TKI therapy or disease management approach.
• QuantideX^® qPCR BCR-ABL minor Kit -– for detecting and quantifying minor (e1a2) BCR-ABL1 fusion transcripts. Results are reported automatically as both BCR-ABL1/ABL ratio and ABL copy number. It is CE marked for U.S. export only.

Key benefits of the assays include unsurpassed sensitivity to better assess clinical response, rapid time-to-result with minimal hands-on-time, multiplexed assay design to enable throughput of up to 49 samples, and Armored RNA^®-based standards that provide accurate RNA quantification. The QuantideX^® qPCR BCR-ABL IS and minor kits offer validated clinical sensitivities that detect residual amounts of disease down to 0.002% IS (MR4.7 LOD) and 0.0025% ratio (LR4.61), respectively, both determined using clinically representative samples, not human-derived cell lines. The simple, streamlined and common workflow of both kits facilitates high ease of implementation and empowers laboratories of all sizes to offer high quality, routine BCR-ABL testing. The kits have been validated in thousands of clinical specimens and together provide significant coverage of major and minor breakpoints.

About Asuragen

Asuragen is a molecular diagnostic company changing the way patients are treated in genetics and oncology. The quality, simplicity and sensitivity of its products brings precision medicine within reach. Asuragen’s diagnostic systems, composed of proprietary chemistry and software, deliver powerful answers using broadly installed instrument platforms. Asuragen is a product foundry rapidly and efficiently addressing current and emerging clinical needs including cancer diagnosis and monitoring, reproductive health and aging, serving laboratories across a patient’s lifespan with its best in class diagnostic tests. For more information, visit www.asuragen.com .

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Contact information

Asuragen, Inc.
Lynne Hohlfeld, 512-681-5200
SVP, Corporate Development and CFO
lhohlfeld@asuragen.com
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