Lineagen

About Lineagen

Lineagen, a subsidiary of Bionano Genomics, is a biotechnology company specializing in genetic diagnostic services for children with neurodevelopmental disorders, including autism spectrum disorder (ASD) and developmental delays. Founded in 2006 by Michael S. Paul and Andy Peiffer, the Salt Lake City-based company was established through collaborations with the University of Utah and The Children's Hospital of Philadelphia to identify genetic variants associated with ASD. Michael S. Paul, who served as CEO, has over 25 years of experience in the life sciences industry. In August 2020, Bionano Genomics acquired Lineagen for approximately $9.6 million, integrating Lineagen's CLIA-certified diagnostic services and expertise in cytogenetic assays and reimbursement with Bionano's Saphyr genome imaging platform. Following the acquisition, Michael Paul became the Chief Strategy Officer of Bionano.

The company's business model centers on providing comprehensive, physician-prescribed genetic testing services. Clients primarily consist of healthcare providers and families seeking diagnoses for childhood developmental conditions. Revenue is generated through these testing services, with a dedicated team handling insurance pre-authorizations and appeals to make the tests accessible. Lineagen offers a portfolio of Laboratory Developed Tests (LDTs), including its proprietary FirstStepDx Plus chromosomal microarray (CMA), which detects large genomic deletions and duplications. Other services include testing for fragile X syndrome, whole exome and whole genome sequencing, and pharmacogenomic testing, all conducted from simple cheek swab samples. The company also provides access to genetic counselors to discuss results and support families. As part of Bionano, Lineagen now also offers Optical Genome Mapping (OGM) data services for research, aiming to enhance the diagnostic capabilities for structural variations in the genome.