NEW YORK – Genetron Health said today that it has received a CE mark for its proprietary human B lymphocyte minimal residual disease detection test kit, Seq-MRD, enabling the kit to be sold in the European Union and other countries that recognize the CE mark.
The assay is designed to detect the CDR3 regional sequence of the IgH/K/L gene of the B cell receptor in bone marrow samples collected from patients with B lymphocytic leukemia and multiple myeloma before and after treatment.
Based on Genetron's "One-step Seq" method, the kit allows DNA library construction to finish with a single PCR, minimizing the risks of sample contamination and false-positive results.
The Seq-MRD test joins a handful of other tests for which Genetron has received a CE mark, including PCR-based kits for IDH1 and TERT gene promoter mutation kits, and various tumor sequencing panels.