Genetron Health has obtained the CE mark for its human B lymphocyte minimal residual disease detection test kit, Seq-MRD.

The assay has been designed for the detection of the CDR3 regional sequence of the IgH/K/L gene of the B cell receptor (BCR) in bone marrow samples, which are collected from B lymphocytic leukemia (B-ALL/CLL) and multiple myeloma (MM) patients before and after treatment.

The company stated that the process helps in detecting minimal residual disease, and provides a reference for the follow-up treatment of cancer survivors by sorting significant and specific clonal rearrangement forms in a patient’s tumour cells.

Developed using next generation sequencing (NGS) technology, the Seq-MRD test has been optimised with the company’s ‘One-step Seq Method’ that allows the DNA library construction process to finish with a single PCR, and reduces the chances of sample contamination and false-positive results.  

The combination of this operational feature with Genetron’s automated bioinformatics analysis solution enables the new kit to have a range of application prospects.

Genetron Health said in a statement: “Recently, an experiment was completed that identified the assay performance in various perspectives, such as sensitivity, accuracy, specificity and precision, among which 128 clinically confirmed samples showed a high concordance on positive detection results from the Seq-MRD assay, and the traditional technology of flow cytometry (FCM).”

The company and Jiangsu Fosun Pharmaceutical Sales have entered an exclusive commercialisation agreement for the Seq-MRD assay, in October last year.

Genetron also obtained the CE mark for other tests including the Human IDH1 and Human 825 Gene Mutation Detection Kits, the Human TERT Gene Promoter Mutation Detection Kit, and the Human 8-Gene Mutation Joint Detection Kit.