Bionano Genomics, Inc. filed a Form 8-K on September 14, 2026, announcing that Albert Luderer, Ph.D., currently serving as Chairman and Interim Chief Executive Officer, is scheduled to present at the H.C. Wainwright 28th Annual Global Investment Conference. The company furnished a copy of the presentation referenced in the filing as Exhibit 99.1.
The presentation details the company's focus on Optical Genome Mapping (OGM), a genomic analysis technique intended to transform structural variant analysis. The company states that OGM is transitioning into clinical use and obsoleting major laboratory standards of chromosomal analysis. It highlights that global clinical evidence from oncology and constitutional genetic diseases suggests OGM workflows are becoming critical in clinical analysis.
Regarding market adoption, the company notes that the American Medical Association has established two unique CPT codes for OGM analysis: one for hematologic malignancies and another for constitutional genetics, both designated for routine use as clinical laboratory procedures. The company estimates the total addressable market (TAM) for the global OGM market is approaching $10 billion.
The filing outlines the company's strategy to drive adoption through its Stratys system and VIA software, which are intended to increase throughput and simplify the analysis of OGM data. The company reported that as of December 31, 2025, there were 321 global OGM sites and 387 global installed OGM systems. It also noted that 14 routine customers account for approximately 83% of FY25 consumables revenue.
The presentation emphasizes the extensive validation of OGM, citing 1,335 human clinical research genomes published in Q2 2026, bringing the total to over 16,000 genomes published since 2021. It also highlights data showing OGM revealed additional pathogenic variants in 13% of study subjects and resulted in a diagnostic yield increase of 12% in rare disease cohorts.
