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Bionano Announces Three New Peer-Reviewed Studies Demonstrate Clinical Value of Bionano's Optical Genome Mapping Across Myelodysplastic Syndromes and Acute Myeloid Leukemia

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  • Bionano Genomics announced three peer-reviewed studies demonstrating the clinical utility of Optical Genome Mapping (OGM) in high-risk hematologic malignancies including myelodysplastic syndromes, acute myeloid leukemia, & therapy-related myeloid neoplasms.
  • MD Anderson Cancer Center research found chromoanagenesis in 15.9% of MDS cases, identifying an ultra-high-risk subset with a median overall survival of 9.9 months compared to non-CAG subjects where survival was not reached.
  • University of Oulu study revealed OGM detected clinically relevant structural variants in 46% of cytogenetically normal AML cases, with subjects having OGM-detected abnormalities showing significantly worse overall survival.
  • Josep Carreras Leukaemia Research Institute multicenter study showed OGM was interpretable in 100% of samples, including cases where conventional banding failed, & identified chromoanagenesis as the strongest independent predictor of inferior survival with a hazard ratio of 9.26.
  • Integration of OGM findings into IPSS-R & IPSS-M scoring shifted 16.7% of therapy-related neoplasm subjects & up to 12.8% of younger-onset MDS subjects into higher-risk prognostic categories.
  • All three independent studies confirm OGM can detect prognostically important structural genomic alterations that elude standard karyotyping, FISH, & targeted sequencing panels.
  • Findings support OGM as a tool to refine prognostication beyond current classification systems & enable identification of patients for early allogeneic transplantation or targeted clinical trials.
  • Al Luderer, Bionano's chairman & interim CEO, stated the studies highlight that a meaningful fraction of high-risk genomic complexity is invisible to conventional karyotyping.
  • The press release includes forward-looking statements regarding future results, business strategy, & market adoption, noting risks such as the need for additional financing & regulatory changes.
  • Bionano products are currently designated for research use only & not for diagnostic procedures.