Approval in Canada Adds to the Current U.S. and European Union Regulatory Clearances

Austin, Texas — 11/13/2018 — Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, today announced that its QuantideX qPCR BCR-ABL IS Kit has received Health Canada approval. In 2016, this test became the first FDA-cleared assay for the ultra-sensitive detection and quantification of major breakpoint (e13a2, e14a2) BCR-ABL1 fusion transcripts for use in monitoring molecular response in patients with chronic myeloid leukemia (CML) regardless of tyrosine kinase inhibitor therapy or disease management approach. It is also CE marked for clinical use in the European Union.

Key benefits of the assay include unsurpassed sensitivity (LOD of MR4.7 (0.002%IS)) determined using clinically representative samples rather than human-derived cell lines, rapid time-to-result with minimal hands-on-time, multiplexed assay design to enable throughput of up to 49 samples per run, and Armored RNA^®-based standards that provide accurate RNA quantification. The assay also features a software application to objectively and automatically report results on the International Scale via an in-run four-point calibrator system. The assay is indicated for use on both the Applied Biosystems^® 7500 Fast Dx Real-Time PCR instrument and the Roche Diagnostics cobas z 480 Analyzer.

“We are thrilled that the benefits of our QuantideX qPCR BCR-ABL IS Kit are now available to patients, clinicians, and laboratorians in Canada,” said Matthew McManus, M.D., Ph.D., president and CEO of Asuragen. “With this new clearance, we continue to deliver on our commitment to provide better answers to CML patients around the world.”

About Asuragen
Asuragen is a molecular diagnostic product company changing the way patients are treated in genetics and oncology. Asuragen’s diagnostic systems, composed of proprietary chemistry and software, deliver powerful answers using broadly installed instrument platforms. They are simple to adopt and expand the ability to serve patients. 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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