Based on the next-generation sequencing technology, the kit can detect minimal residual disease and provide a reference for the follow-up treatment of cancer survivors
The CE mark approval will allow Genetron to enter the European market. (Credit: fernandozhiminaicela from Pixabay)
China-based precision medicine provider Genetron Health has received the CE mark for its human B lymphocyte minimal residual disease detection test kit, Seq-MRD.
Based on the next-generation sequencing technology, the kit can detect minimal residual disease and provide a reference for the follow-up treatment of cancer survivors.
Seq-MRD is meant for the testing of the CDR3 regional sequence of the IgH/K/L gene of the B cell receptor (BCR) in bone marrow samples collected from patients with B lymphpocytic leukaemia (B-ALL/CLL) and multiple myeloma (MM) before and after the treatment.
The firm said that the kit sorts out the significant and specific clonal rearrangement formed in the tumour cells to detect the minimal residual disease.
Seq-MRD test has been optimised with the firm’s ‘One-step Seq Method’ to allow the DNA library construction process to finish with a single PCR, eliminating the chances of sample contamination and false-positive results.
The kit along with the company’s automated bioinformatics analysis solution has technological advantages of high throughput, fast turnaround, stability and accuracy, and high cost-efficiency.
Genetron Health performed a trial to check the performance of the test in terms of sensitivity, accuracy, specificity and precision.
Among all, 128 samples showed high concordance on positive detection results from the Seq-MRD assay and the traditional technology of flow cytometry (FCM).
In addition, the Seq-MRD assay detected 10 samples as positive which were shown negative by FCM.
In October last year, Genetron Health and Jiangsu Fosun Pharmaceutical Sales signed an exclusive commercialisation agreement for the sale of Seq-MRD in China.
The firm also obtained 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.