Bionano Genomics, Inc. (NASDAQ:BNGO) announces a summary of the results obtained by the University Hospitals Leuven, Belgium with optical genome mapping (OGM) with Bionano’s Saphyr® system. An assay was developed for whole genome analysis of acute lymphoblastic leukemia (ALL) subjects which, relative to traditional methods, resulted in a workflow with significantly faster turnaround time, higher success rates, and lower cost per sample. The key benefits of their OGM-based assay, as presented by Dr. Barbara Dewaele, are summarized below:
| OGM Benefits | Summary of Findings Presented |
| Faster Turnaround Time | • Turnaround time, for sample to reportable result, went from 4 weeks with traditional methods to only 1 week using OGM |
| Workflow Simplification and Assay Consolodation | • Reduction in the number of cumbersome and expensive FISH experiments from 10 to only 1 per patient, eliminating the use of MLPA and most PCR tests, and reducing the number of samples analyzed via karyotyping |
| Less Hands-On Time | • Significant reduction in hands-on time for laboratory personnel and the time necessary for data analysis using OGM relative to traditional methods |
| Higher Assay Success Rates | • Higher assay success rates versus traditional methods since OGM is performed directly from the sample source, using DNA extraction, without the additional need for laborious cell culture as required for karyotyping |
| Higher Yield of Pathogenic Findings | • 5% of cases yielded additional pathogenic findings using OGM, which would be missed by traditional methods alone |
| Improved Outcomes | • An addiitonal 5% of cases resulted in an improvement in treatment recommendation from enhanced prognostic stratification using OGM relative to traditional methods |
| Lower Cost per Sample | • Reduction in cost by 50% per sample by using OGM instead of the combination of traditional methods |
In a plenary talk at the European Cytogenomics Conference (ECA), Dr. Barbara Dewaele, supervisor of the Routine Diagnostics Laboratory for Genetics of Hematological Malignancies, announced results of implementing an assay they developed with Bionano’s Saphyr system for ALL patients at the largest academic hospital in Belgium. The results are the outcome of a comparative study of 40 ALL subjects whose samples were analyzed by OGM and by a workflow comprising traditional methods, including karyotyping, fluorescent in-situ hybridization (FISH), multiplexed ligation polymorphism assay (MLPA) and polymerase chain reaction. OGM showed 100% concordance with the traditional methods with no false positives. Dr. Dewaele summarized that their hospital plans to develop more OGM-based assays for other types of leukemias. They have already developed one for the muscle disease facioscapulohumeral muscular dystrophy (FSHD).
Erik Holmlin, PhD, CEO of Bionano Genomics commented: “The work completed by Dr. Dewaele and her team in developing an OGM assay for ALL subjects and comparing it to traditional methods has generated a dataset that makes a compelling case for the value of using OGM with our Saphyr system. They have implemented this assay and it has been evaluated and accredited as part of a novel workflow that transforms the way genome analysis for ALL happens in their institution and paves the way for new assays, including one developed for FSHD.”