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Medical Devices / Submissions and Approvals

Asuragen Expands CE Mark on Cancer Monitoring Assays for Use on Roche Analyzer

Feb. 5, 2018

Molecular diagnostic product developer Asuragen expanded its CE Mark on two chronic myeloid leukemia monitoring assays for use on the Roche Diagnostics cobas z-480 Analyzer.

The QuantideX qPCR BCR-ABL IS Kit and the QuantideX qPCR BCR-ABL minor Kit can detect and quantify major or minor fusion transcripts, with automated reports of the results.

They are intended to provide improved sensitivity for clinical assessments of patients’ response to tyrosine kinase inhibitor therapies.

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