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Leuven University Hospitals in Belgium describe their menu

SAN DIEGO, December 23, 2021 (GLOBE NEWSWIRE) – Bionano Genomics, Inc. (BNGO), pioneer of optical genome mapping solutions (GMO) on the Saphyr ® system and provider of the leading software solutions for the visualization, interpretation and reporting of genomic data, announced today that the University Hospitals of Leuven in Belgium, after previously receiving its accreditation from the Belgian Accreditation Body (BELAC) for the use of GMOs in the analysis of acute lymphoblastic leukemia (ALL), its menu, accredited by BELAC, is expanding, includes acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL) and facioscapulohumeral muscular dystrophy (FSHD).

"With the flexibility we now have as a BELAC accredited laboratory, our teams are able to develop GMO-based assays that address hematologic malignancies without the need for a re-audit," said Barbara Dewaele, PhD, Laboratory Supervisor of Genetics of Malignant Disorders in Leuven University Hospitals. "We are excited to continue using this valuable tool to analyze the genomes of cancer patients and rare diseases."

At the European Cytogenomics Conference in July 2021, Dr. Dewaele shared the results of the implementation of an ALL-based GMO-patient trial that his team developed with the Saphyr ® system from Bionano. As presented by Dr. Dewaele and her team, compared to their existing workflow, the new workflow that includes OGM as the primary analysis method reduced the number of fluorescence in situ hybridization probes used by 90% and eliminated the need for multiplexed ligation polymorphism assays. In its new workflow that includes GMOs, it is complemented with karyotyping to detect ploidy changes and the presence of small subclones. This transformation resulted in a faster 14-day response time, cost savings of approximately 50%, and higher overall success rates in finding pathogenic variants in samples.

In parallel, as part of its menu expansion efforts, and under the direction of Dr. Valérie Race, Center for Human Genetics at Leuven University Hospitals, a validation of Bionano's EnFocus ™ FSHD tool will be carried out at a Prospective cohort of FSHD samples to confirm the ability of GMOs to accurately measure the length of D4Z4 repeat arrays and assess workflow reproducibility and repeatability. Preliminary results were presented at the European Society for Human Genetics conference in August 2021, and reported that GMO can be a powerful and robust technique for FSHD testing in genetic diagnostic laboratories by providing results that are consistent with the current gold standard, Southern blot analysis in a substantially simpler workflow that does not use radioactivity.

Dr. Dewaele reported that she and her colleagues have doubled their weekly sample volume relative to when they started using their Saphyr system and believe they are on track to reach their goal of 500 samples per year with this instrument. The Leuven University Hospitals teams believe that the time and cost savings from using GMO-based assays could be a competitive advantage over traditional techniques. GMO is also complementary to many of the tools used in typical molecular pathology and cytogenomic laboratories and, as a result, can be helpful in interpreting assay results such as karyotype, which can be used to confirm GMO findings.

Erik Holmlin, PhD, President and CEO of Bionano Genomics, commented: “We are impressed by the drive and perseverance of Dr. Dewaele and all the Leuven teams, which has enabled the hospital to expand its laboratory testing portfolio. We are delighted that University Hospitals Leuven has determined its plans for menu expansion, which are facilitated by accreditation and the formal confirmation letter received from BELAC. We believe that the path followed by Dr. Dewaele is indicative of what other laboratories can follow to make GMO an essential and widely used method in clinical genomics research, "said Dr. Holmlin. “OGM can enable new workflows that are faster and provide answers to questions quickly, which can allow treatment decisions to be made earlier. Since GMO has been shown to find clinically relevant variants that other techniques can miss, it can also provide answers to questions that researchers may not know they had about these specific cancers and genetic diseases. ”

Dr. Barbara Dewaele will be presenting at the Bionano Symposium on January 11, 2022. At the Symposium, more than 25 respected speakers from around the world will present their latest scientific discoveries using the Bionano Saphyr System for GMOs in Constitutional Cytogenomics, Hematological Neoplasms , solid tumors, and in combination with next-generation sequencing. A link to register for the Bionano Genomics Symposium 2022 is available at[19459005

About Bionano Genomics

Bionano is a provider of genome analysis solutions that can enable researchers and clinicians to reveal answers to challenging questions in biology and medicine. The company's mission is to transform the way the world views the genome through GMO software, diagnostic services and solutions. The company offers GMO solutions for basic, translational and clinical research applications. Through its Lineagen business, the Company also provides diagnostic testing for patients with clinical presentations consistent with autism spectrum disorder and other neurodevelopmental disabilities. Through its BioDiscovery business, the Company also offers an industry-leading, platform-independent software solution that integrates next-generation sequencing and microarray data designed to provide variant number analysis, visualization, interpretation and reporting. copy, single nucleotide variants and absence. genome-wide heterozygosity in a consolidated view. For more information, visit or .

Forward-Looking Statements by Bionano Genomics

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may", "will do "," expect "," plan "," anticipate "," estimate "," intend "and similar expressions (as well as other words or expressions that refer to future events, conditions or circumstances) convey uncertainty of future events or results and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our current intentions, beliefs, projections, prospects, analysis or expectations regarding, among other things: the inability or delays at Leuven University Hospitals to expand their menu; the inability of other laboratories to use the steps taken by Leuven University Hospitals to make GMO a widely used method; the ability of the University Hospitals of Leuven to continue processing the largest volume of samples; OGM's ability to provide new and faster workflows; The ability of GMOs to find clinically relevant variants that other techniques miss and to provide answers to questions not yet asked; Dr. Dewaele's ability to present at the Bionano Symposium; and the impact of expanding our business leadership team, including our expectations for the growth of Saphyr ® and our ability to strengthen customer care and expertise globally . 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 can 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, technologies, or improvements to existing technologies; GMO failure to function accurately and consistently as noted by University Hospitals Leuven or others; the subsequent results could negate the results observed by the university hospitals of Leuven or others; changes in our strategic and business plans; our ability to obtain sufficient funding to fund our strategic plans and marketing efforts; the ability of research and medical institutions to obtain funds to support the adoption or continued use of our technologies; 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, but not limited to, our Annual Report on Form 10-K for the year in which ended on December 31st. , 2020 and in other documents subsequently filed by us with the Securities and Exchange Commission. All forward-looking statements in this press release speak only as of the date they were made and are based on management's assumptions and estimates as of that date. We do not undertake any obligation to publicly update any forward-looking statement, whether as a result of the receipt of new information, the occurrence of future events, or otherwise.

Company contact:
Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610

Investor Relations:
Amy Conrad
Juniper Point
+1 (858) 366-3243

Media Relations:
Michael Sullivan
+1 (503) 799-7520

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