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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:
About this update from Bionano Genomics, Inc.
[{"type":"text","content":"IRB-approved, multi-site, ongoing study evaluated 200 samples representing 123 unique prenatal cases across 9 sites for interim measures of key endpoints: Results of OGM analysis were comparable, in a single assay, to the results of two separate standard of care (SOC) tests needed to reach a diagnosis in 56% of cases (69/123) and to three separate SOC tests needed to reach a diagnosis in 19% of cases (23/123)Concordance with SOC for all calls – 100% [200 out of 200 samples]Concordance with SOC for variant calls – 100% [78 out of 78 variants]Reproducibility of analytical QC from site-to-site – 100% [83 out of 83 replicates]Reproducibility of variant calls from site-to-site – 100% [83 out of 83 replicates] 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. “The process of establishing a consortium like this one to conduct a multi-site trial program is made possible by capable principal investigators and leading sites,” commented Alka Chaubey, PhD, FACMG, chief medical officer of Bionano. “We believe the trial is off to a terrific start, with a total of 414 subjects enrolled to date and with an interim readout of 123 subjects and 200 sample runs that show OGM performing very well. We look forward to the investigators proceeding with the remaining samples and evaluating other critical endpoints like comparative diagnostic yields, turnaround times and health economic impacts.” Study DesignThe study is an Institutional Review Board-approved, multicenter, double-blinded trial with samples from 123 clinical research subjects analyzed in a total of 200 sample runs to date. All samples had been previously tested with traditional methods like ...