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CMS Posts Preliminary Payment Determination for New Category I CPT Code Covering Use of OGM for Constitutional Genetic Disorders
Globenewswire· 2025-09-15 11:00
SAN DIEGO, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (Nasdaq: BNGO) offering CLIA-certified laboratory developed tests (LDTs) based on optical genome mapping (OGM), today announced that Centers for Medicare & Medicaid Services (CMS) posted the preliminary payment determination for the Category I Current Procedural Terminology (CPT®) code for use of OGM in cytogenomic genome-wide analysis to detect structural and copy number variations relate ...
Bionano Reports Second Quarter 2025 Results and Highlights Recent Business Progress
GlobeNewswire News Room· 2025-08-14 20:01
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].