Largest Hospital Diagnostic Lab in Canada Pilots Bionano’s Saphyr; Seeking to Convert 30-Year-Old Workflow Based on Multiple Technologies Into a Single, High-Resolution Assay to Transform Cancer Diagnosis

SAN DIEGO, Feb. 09, 2021 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO), announced today that its Saphyr system is being piloted by the University Health Network’s (UHN) Laboratory Medicine Program (LMP) in Toronto. The LMP is the largest hospital diagnostic laboratory in Canada and one of the largest in the world, performing 25 million tests per year and serving 1,300 patients per day. UHN’s Cancer Cytogenetics Laboratory led by Dr. Adam Smith plans to use the Bionano Saphyr system to test its ability to streamline cancer diagnostic techniques, improve detection of abnormalities and reduce complexity and costs.
Dr. Adam Smith commented: “The hope is to leverage the unique power of optical genome mapping (OGM) by developing new Saphyr-based assays intended to resolve diagnostic questions that are challenging with existing standard of care tools. Cytogenetics, and specifically G-banded karyotyping, is a core technique for looking at chromosomal changes in cancer patients and has been a core technique of cytogenetics laboratories for over 30 years. Karyotyping has provided a cost-effective means to assess chromosomal changes at the genome level, but it is labor intensive and has limited resolution to identify specific rearrangements. While other techniques such as Fluorescence In Situ Hybridization (FISH) have supplemented karyotyping, FISH is a targeted assay requiring continued validations and workloads for new and emerging cancer biomarkers. New technologies, such as OGM, may represent a better alternative and increase the precision of detecting chromosomal changes in cancer. This could lead to the clinical reality of a single assay, high-resolution analysis across the entire genome.”Erik Holmlin, PhD, CEO of Bionano Genomics commented: “It is gratifying to see increasing adoption of Saphyr as the evidence continues to mount showing how Saphyr can consolidate multiple antiquated techniques into a single, streamlined approach for cytogenomic analysis. This pilot by Canada’s largest hospital diagnostic laboratory is a significant milestone for us as we seek to make OGM with Saphyr a cornerstone of efforts to improve cancer diagnosis and discover new medicines. We thank Dr. Smith and his colleagues for their commitment to us and we are impressed by their innovative drive.”About Bionano Genomics
Bionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business. Bionano’s Saphyr system is a research use only platform for ultra-sensitive and ultra-specific structural variation detection that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools. Bionano provides genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. Lineagen has been providing genetic testing services to families and their healthcare providers for over nine years and has performed over 65,000 tests for those with neurodevelopmental concerns. For more information, visit www.bionanogenomics.com or www.lineagen.com.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” 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 strategic plans of UHN’s Cancer Cytogenetics Laboratory, including its plans to develop Saphyr-based assays; Saphyr’s capabilities in comparison to and in conjunction with other genome analysis technologies, including in the comprehensive analysis of cancer genomes; the potential for Saphyr to streamline cancer diagnostic techniques, including its abilities to reduce or eliminate sequential and confirmatory assays, improve detection of abnormalities, reduce complexity and costs and help facilitate the discovery of new treatments; our expectations regarding the adoption of Saphyr as a clinical tool to replace traditional standard of care cytogenomic testing methods; and the execution of Bionano’s strategy. 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 the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; the loss of key members of management and our commercial team; 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, 2019 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@bionanogenomics.comInvestor Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 (617) 430-7577
arr@lifesciadvisors.comMedia Contact:
Darren Opland, PhD
LifeSci Communications
+1 (617) 733-7668
darren@lifescicomms.com