Session: 612. Acute Lymphoblastic Leukemias: Clinical and Epidemiological: Poster II
Hematology Disease Topics & Pathways:
Lymphoid Leukemias, ALL, Hodgkin lymphoma, Acute Myeloid Malignancies, AML, MDS, adult, CLL, Lymphomas, non-Hodgkin lymphoma, APL, MPN, assays, LGL, B Cell lymphoma, Plasma Cell Disorders, CML, T Cell lymphoma, Chronic Myeloid Malignancies, CMML, pediatric, Diseases, Lymphoid Malignancies, Myeloid Malignancies, emerging technologies, Technology and Procedures, Study Population, Human, omics technologies
Patient blood or bone marrow samples were subject to the Bionano OGM-Dx™ HemeOne assay. OGM analysis was successful for 105/112 (94%) samples with 7/112 (6%) samples failing analysis. Of the 105 analyzed samples, 74 (70%) had abnormal and 31 (30%) had normal findings by OGM analysis, with 49% of abnormal OGM findings classified as complex. At initial diagnosis, 49 cases had guideline and SOC result-based disease risk stratification with 18/49 (37%) graded as high risk, 15/49 (31%) as intermediate risk, and 16/49 (32%) as low risk.
Additionally, 60 cases had SOC cytogenomic analysis (KT or FISH) results available; 37% with KT and FISH, 27% with only KT, and 35% with only FISH. OGM cases with normal findings were concordant with KT in 9/10 (90%) of cases and FISH in 8/12 (67%) of cases. For those cases that had abnormal findings by KT and/or FISH, OGM detected additional cytogenomic findings in 79% of cases. A change of risk stratification was made in 12/42 (29%) of cases with additional findings by OGM analysis compared to KT and/or FISH; 9/12 (75%) with upgraded risk and 3/12 (25%) with downgraded risk stratification. In 10/42 (24%) of cases, OGM findings resulted in a change in therapeutic management recommendations. This is exemplified by an acute lymphoblastic leukemia case: KT detected a sole t(9;22) abnormality however, OGM detected t(9;22) and additional findings of gains at chromosomes 1q, 17q, and 19p and losses at chromosomes 5q, 7p, and 11q (see figure 1), changing the risk stratification from intermediate to adverse and directly leading to a change in therapeutic management.
The impact of OGM on disease risk stratification and case management is in alignment with previously published studies with OGM analysis demonstrating its power to detect additional findings not seen by SOC cytogenomic analysis. The prospective study outcomes suggest a significant role for OGM in delivering comprehensive results for improved diagnostic assessment and significant prognostic information for better case management and care compared to SOC cytogenomic methods.
Disclosures: Wicks: Bionano: Current Employment, Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company. Younan: Bionano: Current Employment. Sahoo: Bionano: Current Employment. Hauenstein: Bionano: Current Employment. Mylavarapu: Bionano: Current Employment. Matthews: Bionano: Current Employment. Hovanes: Bionano: Consultancy.
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