Company Description
Bionano Genomics, Inc. (NASDAQ: BNGO) is a life sciences instrumentation and genomics company that develops and markets genome analysis solutions. According to company disclosures, Bionano focuses on optical genome mapping (OGM), diagnostic services and software that are intended to help researchers and clinicians address complex questions in biology and medicine. Its activities place it within the broader testing and genome analysis space in the professional, scientific and technical services sector.
Bionano describes its mission as transforming the way the world sees the genome through OGM solutions, diagnostic services and software. The company offers OGM solutions for applications across basic, translational and clinical research. These solutions are designed to detect structural variants and other genome-wide changes that may not be fully characterized by traditional cytogenetic or sequencing methods, as reflected in multiple scientific presentations and publications cited in Bionano’s news releases.
Core technologies and product ecosystem
Based on the company’s public statements, Bionano’s business centers on several technology platforms and related products:
- Optical genome mapping (OGM) systems and consumables – Bionano reports that it generates product revenue from sales of its OGM systems and associated consumables. OGM is described in company materials as a technique that can detect structural variants and copy number changes across the genome.
- Saphyr system and OGM platforms – In its prior description, Bionano identifies itself as being engaged in the development and marketing of the Saphyr system, a platform used for ultra-sensitive and ultra-specific structural variation detection. The company continues to emphasize OGM as the core of its genome analysis offering.
- Genome analysis software – Bionano states that it offers a platform-agnostic genome analysis software solution. This software is described as being used with OGM data and other inputs to analyze structural variants and other genomic features.
- Nucleic acid extraction and purification – The company reports that it provides nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology, which supports preparation of DNA or RNA for downstream analysis, including OGM.
- Diagnostic services via Bionano Laboratories – Through Lineagen, Inc. d/b/a Bionano Laboratories, the company offers OGM-based diagnostic testing services. Bionano Laboratories is described as offering CLIA-certified laboratory developed tests (LDTs) based on OGM for hematologic malignancies and constitutional genetic disease, and providing access to OGM for basic, translational and clinical research.
Bionano also notes that it offers an industry-leading, platform-agnostic genome analysis software solution and that its products, unless specifically noted otherwise, are for research use only and not for use in diagnostic procedures.
Business model and revenue sources
According to the company’s own descriptions and financial updates, Bionano’s revenue is derived from several categories:
- Product revenue – The company has stated that it generates product revenue from sales of its OGM systems and consumables, as well as its Ionic purification systems and related consumables. These products include instruments, consumables such as nanochannel array flowcells, and associated software (including VIA software referenced in prior materials).
- Consumables and software utilization – In its third quarter 2025 results, Bionano highlighted a strategic focus on driving consumables and software utilization among what it describes as routine use customers. The company reported growth in consumables and software revenues and emphasized increased flowcell usage and utilization from routine users of OGM.
- Diagnostic and laboratory services – Through Bionano Laboratories, the company offers OGM-based LDTs, such as OGM-Dx HemeOne and OGM-Dx whole genome structural variant tests for postnatal and prenatal applications. Bionano has also emphasized the importance of reimbursement via Category I Current Procedural Terminology (CPT) codes 81195 and 81354 for OGM-based tests in hematologic malignancies and constitutional genetic disease.
Bionano has publicly reported that it transformed its business model in 2025 to focus more on routine users of its OGM solutions, with an emphasis on improving its financial profile through reduced cash burn, improved gross margins, and increased adoption and utilization of OGM systems and consumables.
Geographic footprint and markets
In its earlier company description, Bionano stated that it operates in the Americas, EMEA and Asia Pacific, and that the EMEA region generated the majority of its revenue at that time. More recent company communications highlight what Bionano calls strong momentum in key geographies and expanding utilization in new regions, including Japan, where researchers are reported to be using OGM to investigate complex genetic questions. The company regularly participates in international scientific meetings, such as the American Society of Human Genetics (ASHG) and the Association for Molecular Pathology (AMP), where multiple studies using OGM are presented.
Applications and scientific context
Company news releases describe a growing body of peer-reviewed publications and conference presentations that use Bionano’s OGM technology. These studies span a range of research and clinical research applications, including:
- Inherited disease testing and reproductive disorders
- Hematologic malignancies and solid tumors
- Rare disease investigations and neurodevelopmental disorders
- Facioscapulohumeral muscular dystrophy (FSHD) and other genetic conditions
- Acute leukemias, where OGM has been compared with targeted RNA-sequencing panels for detecting gene rearrangements
According to a study cited by Bionano from The University of Texas MD Anderson Cancer Center, OGM was used to detect structural variants and gene rearrangements in acute leukemia research subjects, and the company notes that OGM can complement RNA-seq by detecting structural variants at the DNA level that RNA-seq may not capture. Other conference abstracts referenced by Bionano describe OGM’s use alongside chromosomal microarray, next-generation sequencing and other techniques in constitutional and oncology applications.
Regulatory and reimbursement environment
Bionano has highlighted the role of reimbursement in supporting adoption of OGM-based tests. Bionano Laboratories announced that the Centers for Medicare & Medicaid Services (CMS) clinical lab fee schedule for 2026 indicates a higher payment determination for Category I CPT code 81195, which applies to OGM-based cytogenomic genome-wide analysis in hematologic malignancies. The company also notes the existence of Category I CPT code 81354 for OGM use in constitutional genetic disease. Bionano has stated that these codes are key components for obtaining reimbursement from third-party payers for OGM-based LDTs that can be used as alternatives to legacy cytogenetic methods such as karyotyping, fluorescence in-situ hybridization (FISH) and microarrays.
Capital markets activity and SEC reporting
Bionano is listed on the Nasdaq Capital Market under the symbol BNGO. The company files periodic and current reports with the U.S. Securities and Exchange Commission (SEC), including Forms 10-K, 10-Q and 8-K. In 2025, Bionano filed a registration statement on Form S-1 relating to an offering of common stock, pre-funded warrants and Series E and Series F warrants, and subsequently reported the pricing and closing of a public offering of common stock and warrants that raised gross proceeds of approximately $10 million, as disclosed in its September 2025 press releases and corresponding Form 8-K. The company has also filed multiple Forms 8-K to report quarterly financial results and other material events, and an 8-K/A to correct voting results related to shareholder proposals.
Position within the testing and genome analysis industry
Within the broader testing laboratories and genome analysis industry, Bionano positions itself as a provider of OGM-based genome analysis solutions, platform-agnostic analysis software, nucleic acid extraction and purification technologies, and OGM-based diagnostic services. Its public communications emphasize the potential of OGM to detect structural variants and complex genomic rearrangements in research and clinical research settings, and the company frequently references collaborations and studies conducted at academic medical centers and research institutions around the world.
Risk considerations and forward-looking statements
Bionano’s SEC filings and press releases include extensive forward-looking statement disclosures. The company identifies risks related to its ability to drive adoption of OGM, improve margins, extend its cash runway, obtain additional financing, continue as a going concern, execute on its strategy, and respond to competitive, regulatory and macroeconomic factors. Investors are directed in those documents to review risk factors in Bionano’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for a more detailed discussion of these issues.
Summary
According to its own public statements, Bionano Genomics, Inc. is focused on genome analysis solutions centered on optical genome mapping, supported by software, nucleic acid purification technologies and OGM-based diagnostic services. The company reports that it has shifted its commercial emphasis toward routine users of OGM, consumables and software utilization, and reimbursement-enabled OGM-based laboratory tests, while continuing to support a growing body of research and clinical research applications presented in peer-reviewed publications and at major scientific conferences.