Bionano Genomics Announces Sites within the UK’s National Health System have Adopted its Saphyr System for Optical Genome Mapping

SAN DIEGO, April 21, 2021 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) announced the adoption of its Saphyr system for optical genome mapping (OGM) by two large laboratories belonging to the National Health System (NHS) of the United Kingdom. King’s College Hospital in London and the NHS Regional Genetics Laboratory in Belfast City Hospital have adopted Saphyr systems through the company’s reagent rental program, which entails a commitment to purchase consumables over time in connection with the placement of a system. Both sites are using Saphyr to characterize the genomes of patients with heme malignancies. The site in Belfast will also evaluate Saphyr for the detection of structural variants (SVs) in patients with developmental delay, infertility, rare disease, and other genetic diseases as well.

Dr. Anwar Alhaq, Lead Clinical Scientist and Deputy Clinical Director for NHS Haematology & Pathology at King’s College Hospital, London said: "Timely identification of genomic structural variants is vital for providing diagnostic, prognostic and treatment decisions for hematological malignancies. The South East Haematological Malignancy Diagnostic Service based at King’s College Hospital currently uses a combination of techniques such as karyotyping, fluorescence in situ hybridization (FISH) and SNP arrays to provide a comprehensive analysis of all cytogenetic aberrations. These techniques are expensive, labor-intensive and time consuming and require a diverse and skilled workforce."

Dr. Alhaq added "A number of other pilot studies have already demonstrated the clinical validity of OGM for identifying SVs in both acquired and constitutional abnormalities. We are undertaking a pilot validation study of the Saphyr system to introduce a single, automated cytogenetic workflow providing high-resolution analysis of the genome in a timely manner, ultimately to benefit patient outcomes. We hope that this will ultimately replace the need for the wide range of cytogenetic methods currently used in diagnostic laboratories and will lead to a quicker turnaround time with better defined SV data."

Dr. Shirley Heggarty, Consultant Clinical Scientist at the NHS Regional Genetics Laboratory in Belfast City Hospital said: "As part of a modernization program of the Northern Ireland Regional Genetics Laboratory (NIRGL) we were looking to refresh and update certain of our cytogenetic facilities. Currently NIRGL relies on traditional cytogenetic techniques such as karyotyping, FISH and SNP array to identify the chromosomal changes in patients. When evaluating our options for the future, what was attractive about the Saphyr system is that it has the potential to replace several different clinical tests in one assay, avoiding the need for us invest in additional multiple cytogenetic instruments, savings us time and streamlining our workflow."

Dr. Heggarty added "The pilot study will be used to assess the clinical utility of OGM in the identification of SVs observed in patients with constitutional and acquired chromosomal abnormalities, including but not limited to developmental delay, infertility, rare disease, leukemia and lymphoma patients."

“What we are seeing with recent adoption within the UK NHS and other sites is a validation of the change in our sales model that we adopted in the first half of 2020. Our focus is on accelerating the process for researchers to implement OGM with Saphyr to shorten the time it takes them to generate data. A faster implementation brings revenue sooner compared to a traditional capital sales cycle, and earlier access to Saphyr data may raise awareness of that data sooner,” commented Erik Holmlin, PhD, CEO of Bionano Genomics. “King’s College Hospital London is one of the largest NHS testing centers for heme malignancies and serves a diverse patient population. Meanwhile, NIRGL is the only NHS genetic testing center in Northern Ireland, providing services to that entire population. We are thrilled that these NHS centers have chosen to invest in OGM with the Saphyr system as they begin developing and validating assays on the platform along a path to modernizing their workflows. We believe their success can spark potential adoption by many other NHS testing labs across the UK.”

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 potential for OGM with Saphyr to revolutionize cytogenetic analysis; our beliefs regarding the potential benefits of Bionano’s Saphyr technology; the significance of large SVs in genetic research; 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, 2020 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.com

Investor Relations and
Media Contact:
Amy Conrad
Juniper Point
+1 (858) 366-3243
amy@juniper-point.com