Bionano Genomics Continues to See Expansion in the Adoption of Saphyr for Digital Cytogenetics at Leading Medical Institutions

SAN DIEGO, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. BNGO announced today that its Saphyr system has been adopted through reagent-rentals by four additional institutions in Europe: the Department of Human Genetics, Ruhr University Bochum and the Clinic for Pediatrics III, University Hospital Essen in Germany and the Institute for Medical Genetics and Pathology at the University Hospital Basel and the Institute for Medical Genetics, Zurich in Switzerland.

At each medical institute, integration of Bionano's Saphyr will be used to help validate Bionano's genome imaging technology against standard methods in cytogenetic analysis as a path to streamline the diagnostics workflow for constitutional genetic conditions and for cancer diagnostics. Genome analysis with Saphyr consolidates into a single assay the testing that typically requires three separate structural variant analysis techniques (karyotyping, fluorescence in situ hybridization and chromosomal microarrays). With its demonstrated sensitivity as low as approximately 1% allele fraction, we believe Saphyr meets or exceeds the performance requirements to help drive adoption.

"Building on the recent momentum of Saphyr's integration within multiple leading medical institutes in Italy, Spain and France, we are encouraged by the continued growth and expansion of Saphyr adoption most recently in Germany and Switzerland, particularly during a challenging summer in Europe." said Erik Holmlin, Ph.D., chief executive officer of Bionano. "It's great to see this momentum, which we hope serves as evidence that markets continue to open up and that our recently unveiled reagent rental model is well-received as something that lowers the barrier to Saphyr adoption. Combined with the ongoing validation study at Medicover MVZ, Munich, which is designed to obtain national accreditation for Saphyr in constitutional cytogenetics in Germany, we remain enthusiastic about continued growth in Saphyr adoption for applications in cytogenetics."

Dr. Huu Phuc Nguyen, director of Ruhr University Bochum's Department of Human Genetics, stated, "My team and I are planning to validate Bionano's technology and plan to integrate Saphyr into our workflow. Our aim is to substitute or even replace some older generation technologies to be more efficient and more accurate in our daily work."

Dr. Nils von Neuhoff, professor of molecular genetics at the University Hospital Essen added, "The Hospital Essen and my team are planning to validate the Saphyr system. We are the national reference lab for diagnostics of childhood AML. Among our focuses is the identification of the leukemic stem cell of AML. We plan to analyze this cell, which is central to the disease, using new genetic analysis technologies, including Saphyr. The output of this technology can be used to create genetic profiles of the tumors, optimize therapies and develop new active substances for patients."

Bionano plans to continue driving adoption of the Saphyr System globally and replace or supplement older, outdated cytogenetic technologies to optimize diagnostic outcomes that may enable medical professionals to provide superior care to patients.

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 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, and 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: use of Saphyr by the institutions identified in this press release; our aim to make Saphyr an essential component of the future of cytogenetic analysis of specified diseases and disorders; and Saphyr's ability to provide a comprehensive, fast and accurate molecular analysis of cancer cells, and the resulting improvements in patient treatment. 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; failure of our products to achieve the stated objectives or anticipated benefits; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; 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.com

Investor Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 (617) 430-7577
arr@lifesciadvisors.com

Media Contact:
Darren Opland, PhD
LifeSci Communications
+1 (617) 733-7668
darren@lifescicomms.com