Original from: genomeweb
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.
Source: Bio-Techne Receives IVDR Certification for Chronic Myeloid Leukemia Test
Copyright © 2024 GL events Ruihe (Shanghai) Exhibition Co., Ltd. All Rights Reserved. ( 沪ICP备12004745号-1 )
We deliver the latest IVD news straight to your inbox. Stay in touch with CACLP News.
sign-up for our newsletter today.
To ensure our newsletter hit your inbox, make sure to add @caclp.com to your safe senders list. And, as always, feel free to contact
us with any questions and thanks again for subscribing.
Go back
