Three Top European Sites Adopt Bionano Saphyr® for Cancer, Genetics, and Cytogenetic Applications

SAN DIEGO, March 23, 2020 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that the following top European institutions have recently incorporated the Saphyr® system into their repertoire of solutions for genome analysis and are now operating them across a range of applications: Curie Institute in Paris, France; NHS Lothian in Edinburgh, Scotland; and MVZ Martinsried in Munich, Germany. The Saphyr system is designed to enable comprehensive analysis of genome structure, including genomic structural variations unresolved by current next-generation sequencing (NGS) technology. With these installations, the total number of Saphyr systems installed at customer sites to date is 84.

The Saphyr system was adopted by MVZ Martinsried in Munich, Germany, in connection with an agreement reached in October 2019 to evaluate Saphyr for applications in different areas of cancer research and cytogenetics and to provide access to the system to neighboring research and diagnostic centers. Training and installation has been completed at MVZ, which is part of Medicover, a leading international healthcare and diagnostic service company, operating a large number of ambulatory clinics, hospitals, specialty-care facilities and laboratories in Germany. MVZ has collected data for its first cohort and begun data analysis. The Center for Human Genetics and Laboratory Diagnostics at MVZ is expected to establish Saphyr into its ISO 17501 environment for the analysis of patient samples with genetic disorders and for immunogenetic analysis of the HLA locus after transplant. MVZ is also using Saphyr for the analysis of cancer genomes in solid tumors and in collaboration with Munich Leukemia Laboratory (MLL) in leukemias.

The Institut Curie in Paris purchased a Saphyr system in January 2020 thanks to the support of Region Ile de France. The system has now been installed and the lab fully trained.  David Gentien, head of Curie’s Genomics Platform, commented: “We are excited to bring Bionano to Curie to improve our understanding of genome organization and structure in multiple aspects of cancer biology, in rare disease, and for basic research. We believe the Bionano technology will benefit the many fantastic researchers, pathologists and clinicians at France’s leading research center and hospital group in the fight against cancer, including its rarest forms.” In Curie’s first study using Bionano on aggressive Uveal Melanoma samples, presented at the Festival of Genomics in London on January 29, David Gentien and his team identified several novel fusion genes using a combination of RNAseq, Bionano and short-read sequencing.

The NHS Lothian in Edinburgh, the South East Scotland division of the National Health Service of the UK, in January 2020 entered into an agreement to adopt and use the Saphyr system in its Genetic Services Laboratory. The Genetic Services Laboratory of the NHS Lothian has a history of advocating for the technological improvement of the UK Health system, and it spearheaded the implementation of chromosomal microarray in the clinic for the detection of structural aberration of the genome. Its Head of Cytogenetics Services, Eddy Maher, is renowned for helping set European standards in cytogenetics and developing European quality assessment for the harmonization of cytogenetic testing across Europe. He commented: “Bionano’s genome imaging technology is potentially game changing in the field of cytogenetics and cytogenomics. For the first time ever we have an approach which is able to detect both balanced and unbalanced rearrangements. I anticipate that Bionano will replace many of our existing diagnostic workflows such as karyotyping and microarrays in the very near future.”

“We are excited that our genome analysis technology will be used by these three renowned European institutions to address challenging questions today,” said Erik Holmlin, PhD, CEO of Bionano Genomics. “Now that these sites have been trained and are collecting data, the group of European clinical and research sites that are now able to experience the genomic structural resolution only achieved by Bionano has the potential to enable groundbreaking discoveries in cancer and genetic disease, and, with the help of these key sites, the process of validating and accrediting the Saphyr system for clinical use in the UK and Germany has begun.”

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. 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. For more information, visit www.bionanogenomics.com.

Bionano Safe Harbor Statement

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 anticipated uses of the Saphyr system, potential contributions to groundbreaking discoveries in cancer and genetic disease, support for the Saphyr system for clinical use in the UK and Germany and the effectiveness and utility of the Saphyr system in such settings. 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 that Saphyr may not be as effective as expected or be incorporated as anticipated by our customers, as well as risks and uncertainties associated with 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 key clinical studies to demonstrate the effectiveness of our products; 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) 888-7600

eholmlin@bionanogenomics.com

Investor Relations Contact:

Ashley R. Robinson

LifeSci Advisors, LLC

+1 (617) 430-7577

arr@lifesciadvisors.com

Media Contact:

Kirsten Thomas

The Ruth Group

+1 (508) 280-6592

kthomas@theruthgroup.com

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