Core Insights - Bionano Genomics showcased the advancements of optical genome mapping (OGM) at the AMP Annual Meeting, emphasizing its superior ability to detect structural variants compared to traditional methods [1][4] - The conference featured thirteen studies demonstrating OGM's effectiveness in identifying clinically relevant structural variants, highlighting its potential as a high-resolution technique for understanding complex diseases [2][3] Group 1: OGM Utility and Applications - OGM has been integrated into laboratory workflows, enhancing its application in clinical and translational research settings [3] - Key studies presented included applications of OGM in recurrent pregnancy loss, pediatric low-grade gliomas, and various hematological malignancies [3] Group 2: Research Highlights - Notable presentations included the use of OGM for genome-wide structural variant detection in fresh-frozen tissue and its complementarity with next-generation sequencing in multiple myeloma [3] - The studies collectively illustrate OGM's capacity to uncover genetic mechanisms driving diseases, reinforcing its role in modern genomics [2][3] Group 3: Company Commitment - Bionano Genomics is dedicated to innovating and expanding its OGM platform, aiming to make comprehensive structural variant analysis routine and accessible [4]

Core Insights - Bionano Laboratories announced a significant increase of 47% in the clinical lab fee schedule for the CPT code 81195, raising it from $1263.53 to $1853.22, effective January 1, 2026, which pertains to optical genome mapping (OGM) for hematologic malignancies [1][2][4] Summary by Sections Payment Determination - The Centers for Medicare & Medicaid Services (CMS) previously set the payment for CPT code 81195 at $1263.53, effective January 1, 2025, based on a crosswalk to an existing code. A request for reconsideration led to a unanimous vote by the clinical diagnostic laboratory test committee to re-price the code to $1853.22, effective January 1, 2026 [2] Importance of CPT Codes - CPT codes for OGM are essential for reimbursement from third-party payers for Bionano Laboratories' laboratory developed tests (LDTs). Currently, there are two codes: 81195 for hematologic malignancy analysis and 81354 for constitutional genetic disease [3] Impact on OGM Services - The increase in reimbursement for CPT code 81195 is expected to facilitate the offering of OGM-based LDTs for hematologic malignancies, as it provides a more favorable reimbursement environment. The new payment level is deemed appropriate for the additional data collection and reporting required for OGM in blood cancers [4] Company Overview - Bionano Laboratories, a subsidiary of Bionano Genomics, specializes in optical genome mapping (OGM) testing and offers a range of diagnostic services. The company aims to transform genome analysis through advanced technologies and provides OGM solutions for various research applications [5][6]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on September 11, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Bionano Genomics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Bionano Genomics, Inc. 9540 Towne Centre Drive, Suite 100 San Diego, California 921 ...

Core Viewpoint - Bionano Genomics, Inc. has announced the release of upgraded software versions VIA 7.2 and Solve 3.8.3, along with enhancements to its Stratys Compute server, aimed at improving genomic data analysis and interpretation speed, particularly for hematological malignancies and constitutional genetic disorders [1][2]. Group 1: Software Upgrades - VIA 7.2 automates variant calling, annotation, and interpretation using AI, enhancing the contextualization of variant calls across various data types [1][4]. - Solve 3.8.3 expands its control database of background structural variants (SVs) by 18%, improving sensitivity, specificity, and resolution for SV detection [4][5]. - The upgrades to the Stratys Compute server double the number of cancer samples that can be analyzed per week and expand functionality to include analysis pipelines previously available only on CPU versions [4][5]. Group 2: Company Mission and Offerings - Bionano aims to transform genome analysis through optical genome mapping (OGM) solutions, diagnostic services, and software, catering to basic, translational, and clinical research [3]. - The company provides an industry-leading, platform-agnostic genome analysis software solution and nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology [3].

Core Insights - Bionano Laboratories announced the establishment of a new Category I CPT code for optical genome mapping (OGM) in cytogenomic genome-wide analysis, effective January 1, 2026, which is crucial for reimbursement from third-party payers [1][2][3] Group 1: CPT Code Significance - The new CPT code is the second issued for OGM, following code 81195 established in 2024 for hematological malignancies, indicating that OGM has met rigorous Category I standards [2] - The approval of this CPT code is expected to enhance the awareness and utility of OGM in both oncology and clinical genetic testing communities [3] Group 2: Bionano Laboratories' Offerings - Bionano Laboratories provides CLIA-certified laboratory developed tests (LDTs) utilizing OGM technology to detect structural and copy number variations related to genetic disorders [1][4] - The OGM-Dx Postnatal and Prenatal Whole Genome SV tests are designed to detect all classes of structural variants traditionally tested by multiple methods, showcasing the advantages of OGM over legacy methods [3] Group 3: Company Overview - Bionano Genomics aims to transform genome analysis through OGM solutions, diagnostic services, and software, catering to applications across basic, translational, and clinical research [5]