Bionano Laboratories Receives College of American Pathologists (CAP) Accreditation for its Clinical Laboratory

SAN DIEGO, Aug. 16, 2023 (GLOBE NEWSWIRE) -- Bionano Laboratories, a laboratory services business of Bionano Genomics, Inc. (Nasdaq: BNGO), today announced that it has received Laboratory Accreditation from the College of American Pathologists (CAP) for its Clinical Laboratory Improvement Amendments (CLIA)-certified reference lab. CAP accreditation is awarded to laboratories that meet stringent requirements and maintain the highest standards for laboratory operations of quality, accuracy, and consistency, as outlined by CAP.

CAP accreditation is often required for a clinical service provider to become part of insurance companies’ preferred provider networks for reimbursement. It is also a credential that is frequently sought after by pharmaceutical and biotechnology companies who desire their projects to be conducted under a more robust regulatory structure, especially if the data are intended to be used for a submission to the U.S. Food and Drug Administration.

“I’m proud of the work our team has conducted to first develop CAP and CLIA compliant policies, procedures and practices with the highest level of quality, and then to be able to successfully pass such a rigorous inspection like the one CAP conducts,” commented Alka Chaubey, PhD, FACMG, chief medical officer of Bionano.

“I want to congratulate Alka and the team at Bionano Labs for achieving this milestone. I believe it will help us support the proliferation of optical genome mapping (OGM) in a number of markets, including the cell and gene therapy markets where we believe OGM can offer significant value as part of the quality control for cell bioprocessing,” added Erik Holmlin, PhD, president and chief executive officer of Bionano.

About Bionano Laboratories:

Bionano Laboratories provides access to genetic answers and support utilizing cutting-edge technologies to advance the way the world sees the genome.  Its clinical services offer a genetic testing experience that combines a comprehensive testing portfolio with thoughtful and accessible support options for the diagnostic journey. Bionano Laboratories also offers direct access to optical genome mapping for applications across basic, translational and clinical research. For more information, visit www.bionanolaboratories.com