NGS Technology-Based Assay Detects Minimal Residual Disease in Patients with Lymphatic Hematological Tumors

A new assay based on high-throughput next generation sequencing (NGS) technology can test 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 leukemia (B-ALL/CLL) and multiple myeloma (MM) before and after the treatment. By screening out significant and specific clonal rearrangement form in a patient's tumor cells, this approach can detect minimal residual disease and provide a reference for the follow-up treatment of cancer survivors.

Genetron Health’s (Beijing, China) proprietary Human B Lymphocyte Minimal Residual Disease Detection Kit (Reversible Termination Sequencing Method), which is also known as Seq-MRD, has been optimized with the company’s “One-step Seq Method” technology, which enables the DNA library construction process for gene sequencing to finish with a single PCR and minimizes the risks of sample contamination and false positive results. This simple operational feature, combined with the company’s automated bioinformatics analysis solution, enables Seq-MRD to have broad application prospects due to its key technological advantages of high throughput, fast turnaround, stability and accuracy, and high cost-efficiency.

Image: Genetron has received CE Mark for its human B lymphocyte minimal residual disease detection kit (Photo courtesy of Genetron Health)

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). More importantly, there were 10 samples detected as positive by Seq-MRD assay, which were identified as negative by FCM, demonstrating the higher sensitivity of the assay. Seq-MRD has received a CE Mark, allowing it to be distributed throughout the EU countries as well as the UK.

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