Core Insights - Bionano Genomics showcased the expanding role of optical genome mapping (OGM) in genetic disease research at the ASHG conference, emphasizing its effectiveness in detecting structural variants (SVs) related to various genetic conditions [1][2][3] Group 1: Event Participation - Bionano Genomics participated in the ASHG conference held from October 14–18, 2025, in Boston, highlighting the potential of OGM in genetic research [1] - The conference featured nine studies that demonstrated OGM's ability to detect novel SVs that traditional techniques may miss, underscoring its value in complex genetic conditions [2] Group 2: Scientific Contributions - Presentations included studies on OGM's application in various conditions, such as Duchenne Muscular Dystrophy and facioscapulohumeral muscular dystrophy (FSHD), showcasing its unique capabilities [6] - The studies presented at ASHG 2025 illustrate OGM's potential to provide deeper insights into complex genetic conditions, reinforcing its transformative role in genetic research [3] Group 3: Company Mission and Offerings - Bionano aims to transform genome analysis through OGM solutions, diagnostic services, and software, catering to basic, translational, and clinical research applications [5] - The company also provides OGM-based diagnostic testing services through its subsidiary, Lineagen, Inc. [7]

Core Insights - Bionano Laboratories announced a preliminary payment determination from CMS for a new CPT code for optical genome mapping (OGM) in detecting genetic disorders, priced at $1263.53, which is higher than existing microarray codes [1][2][3] Group 1: CPT Code and Pricing - The new Category I CPT code for OGM will facilitate reimbursement for laboratory developed tests (LDTs) based on OGM, providing a pricing advantage over traditional methods [2][3] - The new CPT code 81354 for constitutional genetic disease analysis is expected to be priced at $1263.53, which is $363.53 higher than code 81228 and $103.53 higher than code 81229 [1][2] Group 2: Clinical Applications and Impact - OGM-Dx™ Postnatal Whole Genome SV and OGM-Dx™ Prenatal Whole Genome SV are expected to be covered under the new CPT code, indicating their relevance in clinical settings [2][3] - The introduction of this CPT code is anticipated to enhance awareness and support for OGM in both oncology and clinical genetic testing communities globally [3] Group 3: Company Overview - Bionano Laboratories, a subsidiary of Bionano Genomics, specializes in CLIA-certified LDTs utilizing OGM technology to advance genetic diagnostics [4][5] - The company aims to transform genome analysis through innovative solutions and diagnostic services, including OGM and related software [5]

Core Viewpoint - Bionano Genomics is focusing on routine users of its optical genome mapping (OGM) systems and VIA™ software to drive revenue and gross profit, achieving a gross margin above 50% in Q2 2025, indicating a successful strategy shift [2][4]. Financial Results - Total revenue for Q2 2025 was $6.7 million, a decrease of 13% from $7.8 million in Q2 2024, primarily due to the discontinuation of clinical services [4]. - Consumables and software revenues increased by 16% compared to the prior year [4]. - Instrument revenue decreased from $2.3 million in Q2 2024 to $1.4 million in Q2 2025, reflecting the company's strategy to focus on routine users rather than new instrument placements [4]. - Adjusted for instrument sales and discontinued clinical services, combined revenue for consumables, software, and remaining services increased by 11% [4]. - The company sold 7,233 nanochannel array flowcells in Q2 2025, a 17% increase from 6,165 flowcells sold in Q2 2024 [4]. - Gross margin was 52% in Q2 2025, up from 33% in Q2 2024 [4][18]. - Operating expenses were reduced by 42% to $11.3 million, with non-GAAP operating expenses down by 53% to $8.8 million [4]. Business Highlights - The installed base of OGM systems increased by 4% to 378 at the end of Q2 2025 [4]. - The company achieved a record of 119 peer-reviewed publications, showcasing the growing utilization of OGM [4]. - Bionano announced upgrades to its VIA and Solve™ software, enhancing genomic data analysis capabilities [4]. - The American Medical Association established a second Category I CPT code for OGM use in cytogenomic genome-wide analysis [4]. 2025 Outlook - The company anticipates Q3 2025 revenue in the range of $6.7 to $7.2 million and full-year 2025 revenue between $26.0 to $30.0 million [11]. - Expectations for new OGM installations have been increased to 20 to 25 for the full year 2025 [11]. - The company ended Q2 2025 with cash and equivalents totaling $27.4 million, providing a cash runway into the first quarter of 2026 [4][11].