• The Stratys^™ instrument for optical genome mapping (OGM) will enable a four-fold increase in raw data generation rate compared to the Saphyr^® instrument. Our plan is to eventually enable labs to develop work-cells comprised of multiple Stratys instruments to reach an increase in data generation rates of up to 13-fold over Saphyr. Approximately 10 Stratys instruments will be available as part of an early access program in the second half of 2023 as our manufacturing capacity increases.
• The VIA^™ software replaces N_xClinical^™ software with a completely new platform for visualization, interpretation and reporting for hematologic malignancies across the main data types used in cytogenomics today – OGM, microarray and NGS. VIA software installations will begin at the end of July.

Bionano’s Stratys system for OGM offers increased throughput capabilities to address the needs of mid and high-volume users. The throughput of the Stratys instrument is up to four times greater than that of Bionano’s Saphyr instrument, it is compatible with the latest G2 chemistry and has a potential sample-to-answer time of 3 days for hematological samples interrogated across the whole genome at high sensitivity to rare variants. The system is designed for maximum lab flexibility by enabling up to 12 single access chips, accessible as they complete runs, without the need to batch multiple samples on a consumable. Commercial rollout of the system will initially include 10 early access sites who will be given the opportunity to adopt it as manufacturing capacity is being expanded, with full capacity expected by early 2024.

VIA software replaces N_xClinical software with a simple and integrated workflow for visualization, interpretation and reporting for data types that are standard across molecular pathology and cytogenomics: OGM, NGS and microarrays. The VIA software is designed to automate variant calling, annotation and interpretation, for enhanced contextualization across multiple variant types and accelerated time to results at a reduced cost. This release also offers a new hematologic malignancy workflow, including curated resources that represent guideline-based targets applicable to hematological disease. A workflow focused on genetic disease is expected later in 2023. VIA installations will begin at the end of July 2023.

“We are pleased to announce two exciting new products that we believe will accelerate adoption of OGM by higher volume users and expand utilization: the Stratys system for OGM and our VIA software with a workflow for hematologic malignancies. Stratys is the next evolution in the OGM workflow and offers labs with high sample volumes greater sample flexibility across a variety of research applications, with enhanced throughput and reduced sample-to-answer time. VIA replaces N_xClinical with a platform that analyzes OGM data alongside other data types and creates a powerful and efficient workflow for data from OGM, NGS and microarrays to be reported separately or integrated into a single report to contextualize all classes of genomic variation and drive meaningful insights,” stated Mark Oldakowski, chief operating officer of Bionano.

Erik Holmlin, PhD, president and chief executive officer of Bionano, commented, “These are the product launches we believe will overcome barriers faced by high-volume users seeking to run OGM on a routine basis in clinical research – faster data generation and streamlined analysis and reporting. The prowess of Stratys for OGM is incredible and the utility of VIA as the platform for visualization, interpretation and reporting of cytogenomic data goes well beyond just OGM users as it touches the NGS communities in cancer and genetic diseases.”