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Bionano Genomics Launches CLIA-Certified Laboratory, First OGM-Based Test

NEW YORK – Bionano Genomics said on Friday that it has launched Bionano Laboratories, a new division that combines the company's optical genome mapping (OGM) data services with the clinical testing services offered by previously acquired Lineagen.

The company also released its first OGM-based laboratory developed test (LDT) for facioscapulohumeral muscular dystrophy (FSHD).

San Diego-based Bionano said Bionano Laboratories, which recently secured Clinical Laboratory Improvement Amendments (CLIA) certification, will offer services to customers, such as hospitals, pharmaceutical companies, and others that "may desire a more robust regulatory structure for their projects" as they implement OGM into diagnostic routines for research applications.

A key strategic objective of Bionano Laboratories, the company said, is to develop a menu of OGM-based LDTs, which include its first assay for FSHD, the second leading cause of muscular dystrophy.

"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," said Bionano President and CEO Erik Holmlin in a statement.