Cancer Genomics Consortium Members Demonstrate 100% Concordance Between Bionano Saphyr and Gold Standard Cytogenetics in Leukemia

SAN DIEGO, May 19, 2020 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (NASDAQ: BNGO) announced that in an online presentation hosted by the Cancer Genomics Consortium (CGC) on May 12, 2020, Dr. Brynn Levy from Columbia University and Dr. Rashmi Kanagal-Shamanna from the MD Anderson Cancer Center each presented updates on their work showing 100% concordance between Bionano Genomics’ optical mapping technology and current gold standard cytogenetic methods.

In his presentation, Dr. Levy reported on a blinded, prospective study comparing the results generated by Bionano’s Saphyr instrument to results from routine clinical testing in CLIA laboratories using current gold standard cytogenetic techniques. On 91 samples from patients with Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) that passed inclusion criteria, Bionano was 100% concordant with karyotyping results. Additionally, Dr. Levy illustrated concordance with chromosomal microarray (CMA) for both the size and the breakpoints of identified aberrations in several cases of ALL and AML. Overall, Dr. Levy noted that Saphyr provided “Tremendous and remarkable concordance with traditional cytogenomic analyses for karyotype, FISH and CMA.”

Dr. Levy described how the current gold standard of leukemia testing requires karyotyping on all samples. When requested by the physician, multiple rounds of FISH with different FISH probes, and/or chromosomal microarray are run in addition. CMA provides a genome-wide scan for copy number variants (CNVs) but cannot detect balanced structural rearrangements or map chromosome structure of large imbalances.

The study run by Dr. Levy is part of the Cancer Genomics Research Network and its members lead cytogenetics departments from Harvard Medical School, PathGroup, Columbia University, Penn State College of Medicine, Mayo Clinic, Seattle Cancer Care Alliance, MD Anderson Cancer Center, Augusta University and Legacy Laboratory Services.

In a second presentation, Dr. Rashmi Kanagal-Shamanna from the MD Anderson Cancer Center gave an update on her study involving 100 samples of patients suffering from Myelodysplastic Syndrome (MDS), a precursor to AML. The clinical management of patients with MDS is largely determined by the number of structural aberrations detected, and therefore a single technology, like Saphyr, that is able to detect all CNVs and balanced rearrangements is desirable. Before the closure of Dr. Shamanna’s lab due to the COVID-19 crisis, she analyzed 13 samples using Saphyr. A combined 39 aberrations that passed inclusion criteria were detected by karyotyping, and all of those variants were detected by Saphyr. Additionally, there was 100% concordance between Saphyr and calls made with CMA. Importantly, Bionano identified critical rearrangements important for prognostication of the disease and identified many novel aberrations that change the R-IPSS risk score, which would alter therapeutic management. 

“The tremendous progress made in the two studies reported here add to similar results of a study on 48 leukemia genomes from Radboud University Medical Center in the Netherlands. The three studies each demonstrate 100% concordance between Bionano’s genome imaging technology and all major cytogenetic methods combined in over 150 leukemia samples,” comments Erik Holmlin, PhD, CEO of Bionano Genomics. “These three studies involving the ten renowned institutes provide significant scientific support for our belief that Saphyr is the future of cytogenetic analysis, and that our technology is ready for widespread clinical adoption.”

Both aforementioned studies are expected to be submitted for publication this quarter. The online presentation from the CGC is available for viewing at https://bionanogenomics.com/library/webinars/.

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.

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 impact of Saphyr on treatment or management of AML and ALL; our expectations regarding the future of cytogenetic analysis and Saphyr’s prominence; Saphyr’s readiness for widespread clinical adoption; and our efforts to execute on our commercial 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 that our preliminary financial information provided in this press release may not be as expected, as well as 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
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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