Seq-MRD® detects minimal residual disease (MRD) in B-lymphoid malignancies, while FusionScan Plus can simultaneously detect a wide range of gene mutations and fusions. The two studies (#1064612, #1062999) verified the high sensitivity and high specificity of the two products, providing important insights for clinical diagnosis, medication guidance and monitoring of cancer relapses.
“Genetron Health developed the Seq-MRD® and FusionScan Plus based on our patented One-Step Seq Technology, which offers significant operational advantages while delivering performance comparable to that of traditional detection methods,” said Dr. Yun-Fu Hu, Chief Medical Officer of Genetron Health. “Seq-MRD® provides an effective way to detect recurrences earlier and improves clinical efficacy in patients with B-lymphoid malignancies. FusionScan Plus provides an effective reference for clinical pathological classification and targeted therapy strategies by detecting gene mutations and fusions.”
“The data from both of these studies further strengthened our confidence in these products’ clinical applications. Genetron Health has signed an exclusive agreement with Jiangsu Fosun Pharma and is working with them to accelerate the application of Seq-MRD® in China’s key hematology hospitals and clinics. FusionScan Plus represents another future exciting product for us to tailor more precise clinical treatment plans for patients,” Dr. Yun-Fu Hu continued.
Seq-MRD®—— A Next Generation Sequencing Assay for Detecting Residual Disease in B-lymphoid Malignancies
After hematological cancer treatment, patients’ bodies may sometimes not respond to treatment, or drug-resistant cancer cells may linger. Therefore, a considerable proportion of patients may still relapse. The number of these residual cancer cells are so small that they do not cause any recurring symptoms in the body, and it is difficult to detect them through traditional clinical methods. In order to accurately detect these residual cancer cells in patients after treatment, Seq-MRD® scans for them through high throughput sequencing of immunoglobulin gene rearrangements. This product’s performance was validated by study #1064612.
Genetron Health incorporated different types of samples in this study, including bone marrow from 56 B-cell malignancy patients, peripheral blood from 40 healthy donors, multiple myeloma (MM) cell line RPMI8226, and B-acute lymphoblastic leukemia (B-ALL) cell line NALM6. Test performance parameters included accuracy, linearity, limit of detection (LOD), repeatability, limit of blank (LOB), and others.
The study showed that high-throughput sequencing of B-cell receptor (BCR) genes also exhibit higher sensitivity and specificity in the detection of MRD in lymphoid malignancies.
FusionScan Plus— An Intergreted DNA and RNA Next Generation Sequencing Assay for Simultaneously Detecting Multiple Gene Mutations and Fusions with Lower Thresholds
Drugs targeting gene fusions have been used in clinical situations to treat cancer patients, and detecting gene fusions and drug resistant mutations can help better predict therapy effectiveness. High-throughput sequencing of integrated DNA and RNA is an ideal method to screen for gene mutations and fusions. However, current assays based on parallel detection of DNA and RNA can only detect specific gene mutations and fusions, and oftentimes need many different samples. Therefore, there is a strong clinical need for an assay that can simultaneously detect a wide range of gene mutations and fusions, and with lower threshold requirements.
Genetron Health has developed a next generation sequencing assay, FusionScan Plus, which uses integrated DNA and RNA as a template for genetic alteration detection. Based on Genetron Health’s One Step Seq Method, FusionScan Plus covers 23 tumor-related genes and 37 fusion genes without a priori knowledge of 5′ fusion partner. The study (#1062999) from examining 76 formalin-fixed paraffin-embedded (FFPE) tissue samples proved that FusionScan Plus demonstrated high accuracy in the simultaneous detection of gene mutations and fusions without a priori knowledge of 5′ fusion partner. It can be used to detect drug sites for cancer patients, even with limited biopsy samples, and presents promising insights for clinical applications.
Source – Globe Newswire