Bionano Announces the Stratys™ System for OGM and VIA™ Software for Hematologic Malignancies

• 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.

SAN DIEGO, June 29, 2023 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the Stratys^™ system for high throughput optical genome mapping (OGM) and VIA^™ software for visualization, interpretation and reporting of genome analysis for OGM, microarrays and next-generation sequencing (NGS) data in one integrated software platform. VIA further incorporates these data into an intuitive and powerful workflow for hematologic malignancies.

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.”

About Bionano

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The Company’s mission is to transform the way the world sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. Through its Lineagen, Inc. d/b/a Bionano Laboratories business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. The Company also offers an industry-leading, platform-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. The Company additionally offers nucleic acid extraction and purification solutions using proprietary isotachophoresis (ITP) technology. For more information, visit www.bionano.com, www.bionanolaboratories.com or www.purigenbio.com.

Bionano’s OGM products are for research use only and not for use in diagnostic procedures.

Forward-Looking Statements of Bionano

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “plan,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of the Stratys system to increase sample throughput compared to the Saphyr system; the ability of the Stratys system workflow to provide a sample to answer time of 3 days for hematological samples; ; the ability of the Stratys system to maximize lab flexibility; the ability the VIA software to automate variant calling, interpretation and annotation, for enhanced contextualization across multiple variant types and accelerated time to results at a reduced cost; the potential of the Stratys system and the VIA software to accelerate the adoption of OGM and overcome barriers to adoption of OGM by high-volume users; our ability to drive adoption of the Stratys system and the VIA software; and execution of our stated strategies and plans. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of geopolitical and macroeconomic developments, such as recent and potential future bank failures, the ongoing Ukraine-Russian conflict, and related sanctions, and the COVID-19 pandemic, on our business and the global economy; the failure of the Stratys system to increase sample throughput; the failure of the Stratys system to increase sample throughput compared to the Saphyr system; the failure of the Stratys system to provide a sample to answer time of 3 days for hematological samples; the failure of the VIA software to automate variant calling, interpretation and annotation, for enhanced contextualization across multiple variant types and accelerated time to results at a reduced cost; the failure of the Stratys system and the VIA software to accelerate the adoption of OGM and overcome barriers to adoption of OGM by high-volume users; the failure of our ability to drive adoption of the Stratys system and the VIA software; execution of our stated strategies and plans ; general market conditions; changes in the competitive landscape and the introduction of competitive technologies or improvements to existing technologies; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts and our ability to continue as a “going concern”; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2022 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTS
Company Contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
eholmlin@bionano.com

Investor Relations:
David Holmes
Gilmartin Group
+1 (858) 888-7625
IR@bionano.com