BNGO

Bionano Genomics, Inc. is a life sciences company providing genome analysis solutions based on optical genome mapping (OGM) technology. Headquartered in San Diego, California, Bionano has developed the Saphyr system, a platform that enables comprehensive analysis of structural variations in the genome including large insertions, deletions, inversions, translocations, and other chromosomal abnormalities that are difficult or impossible to detect with standard sequencing methods. Optical genome mapping provides ultra-long-range genomic information, enabling researchers and clinicians to identify structural variants that drive diseases including cancer, genetic disorders, and complex conditions. The Saphyr system works by labeling genomic DNA at specific sequence motifs, stretching the long DNA molecules through nanochannels, and imaging them to create high-resolution genome maps. This optical mapping approach can analyze structural variations across entire genomes with kilobase to megabase resolution, complementing short-read sequencing technologies that struggle with repetitive regions, large structural variants, and complex rearrangements. Bionano markets Saphyr for research applications and increasingly for clinical diagnostics including constitutional genetic disorders, hematologic malignancies, and solid tumors. The company serves research institutions, academic medical centers, clinical laboratories, pharmaceutical and biotech companies, and increasingly, clinical diagnostic labs incorporating OGM into standard cytogenetic workflows. Bionano has secured FDA clearance for certain clinical diagnostic uses and continues expanding clinical validation and reimbursement. The company faces competition from traditional cytogenetic techniques (karyotyping, FISH, chromosomal microarrays), next-generation sequencing, and other long-range genomic analysis technologies. Success depends on demonstrating clinical utility, achieving favorable reimbursement, driving adoption in clinical laboratories, building published evidence base, expanding platform capabilities, and establishing OGM as standard-of-care for detecting structural variants. Bionano has navigated capital raises, operational scale-up, and market development challenges while working to transition from research-focused revenue to sustainable clinical diagnostics market penetration.