Bionano Genomics, Inc. (NASDAQ:BNGO) today announced the launch of Bionano Laboratories, a new organization that combines Bionano's optical genome mapping (OGM) data services with the clinical testing services previously offered by Lineagen, and the launch of Bionano Laboratories' first OGM-based laboratory developed test (LDT). Bionano Laboratories recently received CLIA-certification for its lab in San Diego. This certification will enable Bionano Laboratories to offer services to customers seeking to implement OGM into their diagnostic routines and for research applications with hospitals, pharmaceutical companies, and other parties that may desire a more robust regulatory structure for their projects.
A key strategic objective of Bionano Laboratories' CLIA lab is to develop a menu of LDTs based on OGM. The first OGM-based LDT developed by Bionano Laboratories is a test for facioscapulohumeral muscular dystrophy (FSHD), which is the second leading cause of muscular dystrophy and an important marker in the evaluation of muscular disorders.
"We are excited to launch Bionano Laboratories, which will enable the ability to scale OGM LDT and research services to meet increasing market testing demands. We believe our CLIA-certified lab will help streamline the diagnostic odyssey for clinicians and their patients, as it will have the potential to detect many different types of genomic variants in a single diagnostic environment. This launch is an important milestone for Bionano, and something we have been working towards since our acquisition of Lineagen," commented Dr. Alka Chaubey, chief medical officer of Bionano Genomics.
Erik Holmlin, PhD, president and chief executive officer of Bionano Genomics added, "We want to congratulate Alka along with her outstanding team for all the work they've done. The development of LDTs will allow Bionano Laboratories to introduce OGM-based assays to interested physicians and to seek reimbursement from insurance companies for these testing services. We believe our ability to offer CLIA-certified services will enable us to execute our growth strategy and to fulfill our vision of changing the way the world sees the genome."
More details on Bionano Laboratories is available at: