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Bionano Genomics Acquires Diagnostics Services Provider Lineagen, Inc. to Accelerate Clinical Adoption of Saphyr for Digital Cytogenetics

Lineagen is a provider of proprietary molecular diagnostics services for individuals showing clinical presentations consistent with neurodevelopmental disorders, including autism spectrum disorder (ASD) and other disorders of childhood development

Acquisition expands Bionano’s commercial footprint by adding a robust commercial-stage diagnostics services business based on a menu of Laboratory Developed Tests (LDTs) and other services performed in a CLIA-certified environment serving a $1 billion market

Lineagen’s team complements Bionano by adding leading cytogeneticists, genetic counselors, laboratory operations and billing experts, clinical commercialization experts, and payor contracts

The addition of Lineagen gives Bionano a unique and powerful combination of centralized and decentralized solutions for genomics research and clinical genomics to help support revenue growth

Bionano’s Saphyr system for comprehensive structural variation detection, together with Lineagen’s expertise in development, commercialization and reimbursement of LDTs through CLIA-certified services, provides the key ingredients to accelerate achievement of our goal of consolidating traditional cytogenetic assays onto Saphyr and obtaining reimbursement for patient testing by third-party payors throughout clinical genome analysis in genetic diseases and cancer

SAN DIEGO, Aug. 24, 2020 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that it has acquired Lineagen Inc., a Salt Lake City, Utah based genetic diagnostic company, further supporting our market leadership in digital cytogenetics and comprehensive genetic diagnostics for pediatric neurodevelopmental disorders. Bionano aims to revolutionize clinical genome testing and genomics research by making comprehensive structural variation analysis a routine process that is accurate, streamlined, efficient and cost effective. Bionano’s Saphyr genome imaging platform has been shown to outperform the current gold standard methods for clinical cytogenetic testing, karyotyping, chromosomal microarray (CMA) and fluorescence in-situ hybridization (FISH). Lineagen specializes in pediatric neurodevelopmental disorders, including autism spectrum disorder and developmental delay, and has developed proprietary technology and commercialized multiple LDTs. With the acquisition of Lineagen, Bionano adds CLIA-certified diagnostic testing services along with expertise in commercializing cytogenetic assays, genetic counseling, third party payor contracts and reimbursement.

“Lineagen has been a pioneer in clinical testing for structural variations in patients with neurodevelopmental disorders, including autism spectrum disorder, developmental delay and other constitutional genetic diseases. These are indications where the information provided by Lineagen’s menu of assays can significantly improve management and they are core areas of strategic and clinical interest to Bionano. This acquisition adds that business and accelerates our efforts to bring Saphyr to clinical testing within a CLIA environment by adding essential skills and relationships with physicians and payors in place at Lineagen,” said Erik Holmlin, PhD, Chief Executive Officer of Bionano Genomics. “We believe the incredible talent and clinical experience at Lineagen, working together with Alka Chaubey, recently appointed as our first Chief Medical Officer, will help drive the development and launch of a menu of genomic assays based on Saphyr’s simple, straightforward workflow. By doing so, we provide a roadmap for others to follow, setting Saphyr on track to consolidate and enhance existing cytogenetic workflows around the world. I want to thank Michael Paul, the founder and CEO of Lineagen, and his board, investors and employees for believing in the power of this combination. Our work is just beginning.”

Michael Paul, PhD, Chief Strategy Officer of Bionano and former CEO of Lineagen added, “Bionano Genomics is a natural fit for Lineagen. Beginning with the commercial introduction of our FirstStepDx Plus assay over nine years ago, which is based on structural variation detection, Lineagen demonstrated that we could innovate in the established field of cytogenetics by combining proprietary content, interpretation software, and genomics databases with state-of-the-art genome analysis technology. Bionano’s Saphyr system for comprehensive structural variation analysis allows the combined companies to expand and accelerate this innovation process and develop, validate and introduce novel tests that outperform those based on traditional sequencing or cytogenetic technologies. Together with Erik and the Bionano team, we are eager and committed to continue our mission of serving individuals with ASD and other disorders of childhood development, their families, and providers with advanced genetic diagnostic solutions. It is time to get to work.”

Bionano paid approximately $9.6 million in consideration for Lineagen, consisting of 6,167,510 shares of Bionano’s common stock, approximately $1.7 million in cash and assumption of approximately $2.9 million in liabilities. Concurrent with the closing of the merger, Bionano also paid approximately $1.1 million to satisfy outstanding principal and accrued interest amounts due pursuant to a Paycheck Protection Program loan issued to Lineagen under the Coronavirus Aid, Relief, and Economic Security Act. Lineagen was advised by EVOLUTION Life Science Partners in connection with the merger.

Author / source: Bionano Genomics / https://www.globenewswire.com/news-release/2020/08/24/2082499/0/en/Bionano-Genomics-Acquires-Diagnostics-Services-Provider-Lineagen-Inc-to-Accelerate-Clinical-Adoption-of-Saphyr-for-Digital-Cytogenetics.html

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