The genetic diagnostic company Lineagen Inc., based in Salt Lake City, Utah, is joining Bionano, further supporting our leadership in digital cytogenetics and comprehensive genetic diagnostics for pediatric neurodevelopmental disorders. Here at Bionano, we aim 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. Our 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 neuro-developmental disorders, including autism spectrum disorder and developmental delay, and has developed proprietary content and Laboratory Developed Tests or LDTs. With Lineagen now a part of Bionano, we add CLIA-certified diagnostic testing services along with a talented team with expertise in commercializing cytogenetic assays, genetic counseling, third party payor contracts and reimbursement.

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

“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. 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 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”