Bionano Announces Publication of Interim Readout from Clinical Trial Run by Consortium Analyzing Optical Genome Mapping as Potential Standard of Care for Prenatal Testing

IRB-approved, multi-site, ongoing study evaluated 200 samples representing 123 unique prenatal cases across 9 sites for interim measures of key endpoints:

SAN DIEGO, Jan. 18, 2023 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (BNGO) today announced the publication of an interim report from an ongoing clinical trial designed to support establishing OGM as part of standard of care (SOC) in diagnosis of genetic disease for prenatal subjects. This publication reports on the prenatal genetic disease clinical trial program to evaluate OGM as an alternative to SOC workflows. This prenatal study focuses on comparing OGM to SOC, including concordance, reproducibility, technical success rates, turnaround time (TAT), diagnostic yield, and health economics. This first interim readout is designed to evaluate endpoints connected to analytical performance in key areas of technical performance and reproducibility of OGM.

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