Summary of What Bionano Genomics Does

Overview

Bionano Genomics is a provider of genome analysis solutions with a focus on optical genome mapping (OGM) technology, diagnostic services, and genome analysis software. The company aims to transform genome visualization and interpretation in research and clinical applications.

Core Technologies and Offerings

• OGM Systems: Includes the Saphyr® system and Stratys™ system, which generate ultra-sensitive, high-resolution data on structural variation (SV) in genomes. These instruments analyze long DNA molecules (average ~250,000 base pairs, up to millions) using proprietary nanochannel arrays, fluorescent labeling, and bioinformatics algorithms. They outperform traditional cytogenetic methods (karyotyping, FISH, CMA) in detecting structural variants larger than 500 base pairs.
• Consumables: Chips used in systems like Saphyr® and Stratys™ for nanochannel analysis, and reagents for DNA labeling and linearization.
• Nucleic Acid Purification: Ionic® Purification system employs isotachophoresis (ITP) technology for high-quality DNA/RNA extraction from various sample types, requiring fewer cells than traditional methods.
• Software: VIA™ software is platform-agnostic, integrating results from OGM, next-generation sequencing (NGS), and microarrays to analyze copy number variants (CNVs), single-nucleotide variants (SNVs), and absence of heterozygosity (AOH). It aims to shorten interpretation time and broaden application scope.
• Laboratory Testing Services (Bionano Laboratories): Provides diagnostic tests using OGM-based laboratory-developed tests (LDTs) for genetic disorders including facioscapulohumeral muscular dystrophy type 1 (FSHD1), hematologic malignancies, and prenatal/postnatal chromosomal abnormalities. Phased out some neurodevelopmental disorder testing services in 2024.

Business and Market Focus

• Research and Clinical Applications:
  • Targets cytogenetics, cancer research, cell and gene therapy, prenatal diagnostics, population genomics, and neurological/cardiological risk assessment.
  • Market opportunity estimated at approximately $10 billion annually, including about $3 billion in cell and gene therapy.
  • Approximately 10,000 cytogenetic labs globally analyze about 10 million samples annually.
• Customer Base:
  • In 2024, installed base of OGM systems grew to 371 units, up 14% from 2023.
  • Sales of flowcells (consumables) totaled 30,307 units in 2024, 15% higher than 2023.
• Market Adoption:
  • Recognized OGM as a key tool in publications by authorities like ACMG and included in ISCN nomenclature.
  • Ongoing benchmarking and publication efforts validate utility over traditional methods.
• Software and Data Analysis:
  • Provides comprehensive genome interpretation for microarray, NGS, and OGM data.
  • Software facilitates detection of structural variants and integration with other genomic data types.

Financial Highlights (as of early 2025)

• Employees: 100 total employees (as of December 31, 2024); 74 in the U.S. and 26 internationally.
• Revenue:
  • Total revenue in 2024 was $36.1 million.
  • Revenue declined compared to prior years due to phasing out testing services related to neurodevelopmental disorders.
• Net Loss:
  • Net losses for 2024: $112.0 million.
  • Net losses for 2023: $232.5 million.
• Cash and Investments (as of December 31, 2024):
  • $9.2 million in cash and cash equivalents.
  • $0.3 million in short-term investments.
  • $11.4 million in restricted cash and investments.
• Capital Raising:
  • Raised approximately $31.2 million in 2024 through multiple offerings (April, July, October, and January placements).
  • Anticipates funding into the first quarter of 2026 but expects to seek additional capital before then.
• Market Capitalization (as of June 28, 2024):
  • Approximately $41.6 million based on a stock price of $40.68 per share (post-reverse split).

Corporate and Regulatory Context

• Business Model Shift: From instrument-only provider to full genomics solutions provider through acquisitions (Lineagen, BioDiscovery, Purigen).
• Regulations: Products largely labeled "For Research Use Only" (RUO); regulatory pathways include potential FDA clearance if used for diagnostic purposes.
• Employees: No unionized workers; active in diversity and inclusion efforts.
• Headquarters: San Diego, California.

Summary

Bionano Genomics develops and markets advanced optical genome mapping instruments and consumables for comprehensive structural variation analysis in research and clinical contexts. It provides software solutions for integrated genome interpretation across multiple platforms, alongside diagnostic testing services for genetic diseases via its CLIA-certified laboratory, seeking to establish OGM as a standard cytogenetic tool. The company has grown its installed base but remains unprofitable, with ongoing financing needs and regulatory considerations impacting its business trajectory.