Bionano Genomics Appoints Dr. Keith Gligorich, Seasoned Leader in CLIA-Certified CAP-Accredited Lab Operations, as VP Operations for Bionano Laboratories

Rhea-AI Summary

Bionano Genomics (BNGO) has appointed Keith Gligorich, PhD, as the new VP Operations for Bionano Laboratories. Gligorich, previously with Guardant Health, brings over a decade of experience in molecular diagnostics and laboratory operations. His role will focus on expanding the lab's offerings to include CLIA-certified and CAP-accredited services, including laboratory developed tests (LDTs) for genetic diseases and hematologic malignancies. This strategic move aims to enhance Saphyr adoption and develop reimbursement pathways with insurance companies.

Positive

• Appointment of Keith Gligorich expected to enhance leadership in laboratory operations.
• Planned expansion of services to include CLIA-certified and CAP-accredited LDTs.
• Integration of variant reporting software NxClinical anticipated to streamline workflows.

Negative

• None.

SAN DIEGO, Nov. 29, 2021 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (BNGO), pioneer of optical genome mapping (OGM) solutions on the Saphyr^® system and provider of the leading software for genomic data visualization, interpretation and reporting, today announced that it has appointed Keith Gligorich, PhD, MB(ASCP)^cm to the role of VP Operations for Bionano Laboratories. Keith was most recently with Guarant Health where he led the build-out of Guardant’s CLIA-certified, CAP-accredited laboratory for blood-based early cancer detection testing. He has over a decade of experience in molecular diagnostic test development and laboratory operations. Prior to joining Guardant Health, Keith held leadership roles at ARUP Laboratories, Navican Genomics and Cradle Genomics. Keith holds a PhD in organic chemistry from the University of Utah.

“We are delighted to have Keith on board. We believe he is an expert when it comes to CLIA labs and lab developed tests (LDTs) operating at the forefront of science and technology,” commented Dr. Alka Chaubey, chief medical officer of Bionano. “We look forward to Keith leading the planned expansion of our offering to include services and LDTs under CLIA-certification and CAP-accreditation within Bionano Laboratories.”

Bionano Laboratories is Bionano’s strategic services offering that provides researchers with access to OGM data to enable them to incorporate OGM into their workflow for clinical and discovery research. Designed to drive and potentially accelerate Saphyr adoption around the world, Bionano Laboratories gives prospective customers access to proof of concept data and rapid demonstrations of the capabilities of OGM with Saphyr.   Bionano began obtaining CLIA certification and CAP accreditation for the San Diego-based Bionao Laboratories in 2021 and plans to expand the scope of services it offers to include laboratory developed tests (LDTs) based on OGM. The menu of OGM-based LDTs is expected to include tests for genetic diseases such as fascioscapulohumeral muscular dystrophy (FSHD) and tests for hematologic malignancies such as acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL). This initial menu is intended to allow Bionano to work with third party payors, such as health insurance companies, to develop pathways for coding, coverage and reimbursement of LDTs based on OGM.  

“We believe Keith joining us from Guardant Health is a strong indication of our exciting trajectory and demonstrates how accomplished leaders can align with our purpose of elevating the health and wellness of all people,” said Erik Holmlin, PhD, president and chief executive officer of Bionano. “Keith brings deep experience which can help us drive our anticipated menu expansion and plans to incorporate the variant reporting software, NxClinical^™ from BioDiscovery, to create comprehensive workflows that integrate next-generation sequencing (NGS) and OGM in a single view. Chromosomal microarrays (CMA) are also expected to be part of the data integration as they represent standard of care in genetic testing under current national and international medical guidelines such as those from the American College of Medical Genetics and Genomics (ACMG). As we work to drive inclusion of OGM into the standard of care as an alternative to traditional methods, the data integration within NxClinical is expected to provide seamless transitions for NxClinical users running the software for their CMA and NGS to adopt and use OGM.”

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 sees the genome through OGM solutions, diagnostic services and software. The Company offers OGM solutions for applications across basic, translational and clinical research. 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-agnostic software solution, which integrates next-generation sequencing and microarray data designed to provide analysis, visualization, interpretation and reporting of copy number variants, single-nucleotide variants and absence of heterozygosity across the genome in one consolidated view. For more information, visit www.bionanogenomics.com, www.lineagen.com or www.biodiscovery.com

Forward-Looking Statements of 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,” “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 Dr. Gligorich's anticipated contributions to the execution of our strategy and product development objectives, including with respect to menu expansion and development of comprehensive workflows through the incorporation of NxClinical and integration of NGS and OGM into a single workflow; our expectations regarding the development of OGM-baed LDTs; and our ability to execute on our business 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 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; our hiring efforts may not achieve the anticipated results; approval processes required by third party payors and overall challenges with obtaining any related regulatory approvals; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; 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, 2020 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:
Amy Conrad
Juniper Point
+1 (858) 366-3243
amy@juniper-point.com

Media Relations:
Michael Sullivan
Seismic
+1 (503) 799-7520
michael@teamseismic.com

FAQ

Who is the new VP Operations at Bionano Genomics as announced on November 29, 2021?

The new VP Operations at Bionano Genomics is Keith Gligorich, PhD.

What qualifications does Keith Gligorich bring to Bionano Genomics?

Keith Gligorich brings over a decade of experience in molecular diagnostics and laboratory operations, having previously worked at Guardant Health and other reputable laboratories.

What will be the focus of Bionano Laboratories under Keith Gligorich's leadership?

Under Keith Gligorich's leadership, Bionano Laboratories will focus on expanding CLIA-certified and CAP-accredited services, including laboratory developed tests for genetic diseases and hematologic malignancies.

How is Bionano Genomics planning to enhance Saphyr adoption?

Bionano Genomics plans to enhance Saphyr adoption through the expansion of offering OGM data and proof of concept services in Bionano Laboratories.

What is the anticipated impact of NxClinical software integration on Bionano's workflow?

The integration of NxClinical software is expected to streamline data analysis and enhance the transition for users adopting optical genome mapping.