Bio-Techne has announced that Asuragen, part of its molecular diagnostics division, has completed class C certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX qPCR BCR-ABL IS kit for monitoring chronic myeloid leukemia (CML).
The kit had previously been CE-IVD marked under the In Vitro Diagnostic Directive, which has now been supplanted by the IVDR.
Regular monitoring is necessary for CML patients to ensure that they continue to receive the most appropriate treatment. The QuantideX kit is a qPCR-based IVD test that quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with CML to monitor their response to tyrosine kinase inhibitor therapy.
The QuantideX kit is scalable, allowing clinical scientists to run up to 49 samples per plate. The firm noted in its statement that the test allows for direct reporting on the international scale and includes analysis software.
