Bionano Genomics Acquires Lineagen to Expand Genetic Testing

Scientist pipetting a DNA sample with the results on a computer sceeen in a laboratory
[Credit: Westend61 / Getty Images]

San Deigo-based genome analysis company Bionano Genomics has acquired Lineagen, a provider of genetic diagnostics—a move Bionano says will support its comprehensive genetic diagnostics for pediatric neurodevelopmental disorders.

Bionano paid approximately $9.6 million for Lineagen, consisting of 6.1 million shares of Bionano common stock, approximately $1.7 million in cash, and assumption of approximately $2.9 million in liabilities.

“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,” the company said in an Aug. 24 news release.

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, Bionano said.

Salt Lake City, Utah-based Lineagen specializes in pediatric neurodevelopmental disorders, including autism spectrum disorder and developmental delay, and has developed proprietary technology and commercialized multiple LDTs.

“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,” said Erik Holmlin, Ph.D., Bionano’s chief executive officer. “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.”

According to Holmlin, the acquisition will accelerate Bionano’s efforts to bring its Saphyr genome imaging platform to clinical testing within a CLIA environment, by adding essential skills and relationships with physicians and payors in place at Lineagen.

“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,” Holmlin said. “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,” Holmlin added.

Michael Paul, Ph.D., chief strategy officer of Bionano and former CEO of Lineagen said 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,” he said.

“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,” according to Paul. “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.”

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