SAN DIEGO—Aimed at bolstering its digital cytogenetics and adding comprehensive genetic diagnostics for autism spectrum disorder (ASD) and pediatric neurodevelopmental disorders, Bionano Genomics Inc. has acquired Lineagen Inc., a Salt Lake City-based genetic diagnostic company, for approximately $9.6 million.
Bionano states that it intends to revolutionize clinical genome testing and genomics research, and the company wants to do that by making comprehensive structural variation analysis on its Saphyr genome imaging platform into a routine process that is accurate, streamlined and cost effective in serving a $1-billion market.
The acquisition expands Bionano’s commercial footprint by adding a commercial-stage diagnostics services business based on a menu of laboratory-developed tests and other services performed in a CLIA-certified environment, accelerating the consolidation of traditional cytogenetic assays onto Saphyr and obtaining reimbursement for patient testing by third-party payors 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,” says Erik Holmlin, CEO of Bionano Genomics. “We believe the incredible talent and clinical experience at Lineagen, can significantly improve management, the core areas of strategic and clinical interest to Bionano.
“This acquisition 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.”
Holmlin tells DDN, “The Saphyr system has been validated in clinical studies as providing a single assay that identifies the same genetic conditions as traditional cytogenetic methods, which would require three separate assays (karyotyping, FISH and chromosomal microarray).
“One of the keys to accelerating widespread adoption of Saphyr by customers seeking to develop assays and validate them as laboratory-developed tests (LDTs) is a clear path towards obtaining reimbursement for the LDTs performed in a CLIA-certified, CAP-accredited setting.”
Bionano is striving to make Saphyr a replacement for traditional methods in cytogenetics.
“With this demonstration of LDT development and reimbursement in-house, Bionano can show that model to others seeking to adopt Saphyr as a roadmap to successful reimbursement, which we believe addresses a key step in the adoption process and therefore will potentially accelerate adoption of the Saphyr System,” Holmlin adds.
This combination of a product offering (systems and consumables) with a services offering (LDTs) in a CLIA-certified setting creates a company with both centralized and decentralized capabilities to make sure anyone seeking to use Bionano data in their research and assay development for patient management will have access, he says.
The bottom line, according to Holmlin, is, “We believe the combination of Lineagen’s offering and our Saphyr system will accelerate our goal of elevating the current standard of care for cytogenetic analyses. Following the acquisition announcement, Bionano now has the opportunity to offer many of the same services that Lineagen had available with respect to diagnostic testing. We will continue to offer these diagnostic services under the Lineagen name as a subsidiary company to Bionano, instead of as an independent entity.”
Michael Paul, former CEO of Lineagen, is now chief strategy officer of Bionano.
Over the past nine years Lineagen demonstrated that it 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, Paul notes.
However, Bionano’s Saphyr system 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, he adds.