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Asuragen Gets CE Mark for QuantideX BCR-ABL Kits on Roche Platform

NEW YORK (GenomeWeb) – Asuragen announced today it has expanded its CE mark on two BCR-ABL tests to enable their use on a Roche platform.

The multiplexed qPCR tests are part of the firms QuantideX portfolio and support therapy cessation for long-term responders to tyrosine kinase inhibitor therapies.

The tests include the QuantideX qPCR BCR-ABL IS Kit, which identifies major (e13a2, e14a2) fusions and was granted premarket approval by the US Food and Drug Administration in 2016, as well as the QuantideX qPCR BCR-ABL minor kit for identifying minor (e1a2) BCR-ABL fusion transcripts in patients with chronic myeloid leukemia.

Both tests are currently CE marked to run on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument. The new designation expands their use to the Roche Diagnostics Cobas z 480 Analyzer.

"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," Matthew McManus, Asuragen's president and CEO said in a statement.