Skip to main content
Premium Trial:

Request an Annual Quote

Bio-Techne Receives IVDR Certification for Chronic Myeloid Leukemia Test

NEW YORK – Bio-Techne announced on Friday that its subsidiary Asuragen has received certification under Europe's In Vitro Diagnostic Regulation for its test to monitor chronic myeloid leukemia patients. 

The QuantideX qPCR BCR-ABL IS Kit is a qPCR-based test to quantify BCR-ABL1 and ABL1 transcripts in blood samples from patients with chronic myeloid leukemia to monitor their response to tyrosine kinase inhibitor therapy, Bio-Techne said in a statement. Laboratories can run up to 49 samples per plate with the test. 

The assay previously received CE-IVD marking in 2015 and premarket clearance from the US Food and Drug Administration in 2016.