Bionano announces publication on expert recommendations for OGM integration

Bionano Laboratories announced the publication in the American Journal of Hematology of expert recommendations from the International Consortium for Optical Genome Mapping for the integration of OGM as a standard-of-care cytogenetic assay for diagnostic workflows in various clinical settings. Nineteen experts from the ICOGM, representing relevant multidisciplinary fields, conducted an in-depth review of the classification of hematolymphoid malignancies using the World Health Organization and ICC criteria and published studies of OGM performance to assess whether OGM could provide a comprehensive analysis of the genome sufficient for better diagnosis, prognosis and treatment compared to existing SOC workflows across several indications. Based on the assessment, the ICOGM developed a set of expert recommendations for OGM as a first-line test in place of karyotyping, fluorescent in situ hybridization and chromosomal microarray analysis in some clinical settings; or as an alternative to the traditional methods in other clinical settings when these traditional methods are insufficient. Summary of Key Recommendations for Clinical Use of OGM: OGM is recommended as a first-line test for AML, MDS, MPN, B-ALL, T-ALL, pediatric leukemias and unexplained eosinophilia and myeloid/lymphoid neoplasms with eosinophilia: OGM is recommended as a first-line cytogenetic tool in place of conventional karyotyping and FISH when high-resolution genome-wide structural variation detection is required. OGM allows for the identification of cryptic fusions of genes for which targeted therapy may be available. OGM avoids the need for large FISH panels or multiple orthogonal assays. OGM’s unbiased detection improves risk stratification and guides targeted therapy. OGM is recommended as an alternative to karyotyping/FISH/CMA for CLL, Plasma cell neoplasms/Multiple Myeloma, aplastic anemia, bone marrow failure syndromes and germline predisposition syndrome: Conventional karyotyping fails or yields no metaphases. FISH/CMA do not detect known abnormalities despite clinical suspicion. Complex or ambiguous chromosomal abnormalities need resolution. Low-frequency or rare hematologic malignancies require cost-effective broad analysis. Additional structural variant data may impact diagnostic clarity or therapy decisions. For CLL/SLL; OGM as a viable alternative to FISH and CMA, except for low-level TP53 deletions.. For plasma cell disorders, OGM is recommended to be effective when used with CD138 enrichment.