Bionano Saphyr Services Offered in CLIA Certified Lab Expands Bionano Genomics’ Clinical Applications

Praxis Genomics is first CLIA Lab to become a Bionano Certified Service Provider, will use Saphyr in its goal to help end diagnostic odyssey for patients.
SAN DIEGO, Aug. 20, 2020 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO), announced today that Praxis Genomics has been certified as a Bionano service provider, becoming the first clinical lab with CLIA certification to offer Bionano genome imaging on Saphyr. The Praxis team provides a complete solution for genome analysis by combining data from Bionano optical mapping with short-read or long-read DNA and RNA sequencing, to provide more precise characterization of all variants and their functional significance. The Bionano certification ensures that customers can expect high quality, accurate, and reproducible genome imaging data to support solving genetic mysteries. The lab is currently in the process of obtaining CAP accreditation.Dr. Peter Nagy, Founder and CEO of Praxis Genomics, brings a vast wealth of knowledge and experience to developing clinical assays. He was one of the first to combine DNA and RNA testing for patients with pediatric malignancies at Columbia University Medical Center and introduced whole-exome based carrier testing at Medical Neurogenetics Laboratories. At Praxis, he continues to push the boundaries of molecular medicine to increase the sensitivity and specificity of diagnostic and carrier testing using whole genome analysis.The addition of Saphyr to Praxis’ CLIA environment can streamline the diagnostic odyssey for clinicians and their patients, since it will enable the detection of all types of genomic variants in a single diagnostic environment. Many DNA mutations are difficult or impossible to detect using sequencing due to the repetitive nature of the genome. Saphyr captures images of extremely long, intact DNA molecules to call structural variations genome wide, including in difficult and repetitive regions of the genome, with ultra-high sensitivity and precision. The addition of Saphyr will support Praxis Genomics’ ability to identify disease causing variants and potential therapeutic interventions for patients who have been suffering with undiagnosed genetic disorders and rare diseases.Erik Holmlin, PhD, CEO of Bionano Genomics commented: “The certification of Praxis Genomics as a Bionano Certified Service Provider signifies a distinct expansion of Saphyr’s market as it enters clinical laboratory environments. Multiple validation studies from around the world are demonstrating Saphyr’s capability to identify disease causing structural variants, and many sites are currently integrating Saphyr in their clinical workflow.  We believe that more CLIA certified labs offering Saphyr services will enable a paradigm shift for molecular diagnostics and cytogenetics, both in cancer and genetic disease.”About Bionano GenomicsBionano 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 StatementsThis 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: conclusions as to Saphyr’s potential as a powerful new tool in cytogenetics or its ability to enable clinical-grade structural variation discovery and genome assembly; Saphyr’s potential contribution to improvements in traditional cytogenetics; Praxis Genomics’s plans to utilize the Saphyr system and our services to, among other things, identify disease causing variants and potential therapeutic interventions; the ability to integrate data from the Saphyr system into other offerings by Praxis Genomics; the expanded adoption and utilization of the Saphyr system by genome analysis scientists and clinicians; Saphyr’s capabilities in comparison to NGS-based methods; and Saphyr’s potential as an indispensable tool for personalized medicine and furthering understanding of cancer in the medical community. 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 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
[email protected]
Investor Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 (617) 430-7577
[email protected]
Media Contact:
Darren Opland, PhD
LifeSci Communications
+1 (617) 733-7668
[email protected]

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