NIH leads, FDA lags When institutions like Jo
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Posted On: 10/31/2025 12:10:09 PM
NIH leads, FDA lags
When institutions like Johns Hopkins and MD Anderson call Optical Genome Mapping (OGM) “revolutionary,” it’s hard to keep accepting the narrative that OGM still needs more “rigorous testing.”
Johns Hopkins published the largest study to date on bone and soft tissue tumors, showing that OGM detected 100% of variants found by karyotyping, FISH, and gene fusion assays, and uncovered additional pathogenic variants in 74% of cases that traditional methods missed. When paired with NGS, OGM enabled diagnostic findings in nearly 98% of cases. MD Anderson’s hematologic studies showed similar results: OGM detected all structural variants in myelodysplastic syndromes (MDS) in a single assay, outperforming standard-of-care methods in speed, cost, and comprehensiveness. These aren’t just endorsements, they’re peer-reviewed validations from top-tier cancer centers.
Globally, OGM is already being used in over 100 labs, with national adoption in places like the Netherlands, Portugal, and Saudi Arabia. The NIH’s sole-source agreement and the CPT code assignment in the U.S. further confirm its clinical utility. So when people say “OGM isn’t ready,” what they really mean is that FDA approval hasn’t caught up yet, not that the science is lacking. FDA clearance is a regulatory hurdle, not a scientific one. It requires formal submissions and manufacturing documentation, not just clinical brilliance. But when world-class institutions and global labs are already using OGM to replace outdated methods, it’s time to stop pretending this is experimental.
The science is in. What’s lagging is the bureaucracy.
When institutions like Johns Hopkins and MD Anderson call Optical Genome Mapping (OGM) “revolutionary,” it’s hard to keep accepting the narrative that OGM still needs more “rigorous testing.”
Johns Hopkins published the largest study to date on bone and soft tissue tumors, showing that OGM detected 100% of variants found by karyotyping, FISH, and gene fusion assays, and uncovered additional pathogenic variants in 74% of cases that traditional methods missed. When paired with NGS, OGM enabled diagnostic findings in nearly 98% of cases. MD Anderson’s hematologic studies showed similar results: OGM detected all structural variants in myelodysplastic syndromes (MDS) in a single assay, outperforming standard-of-care methods in speed, cost, and comprehensiveness. These aren’t just endorsements, they’re peer-reviewed validations from top-tier cancer centers.
Globally, OGM is already being used in over 100 labs, with national adoption in places like the Netherlands, Portugal, and Saudi Arabia. The NIH’s sole-source agreement and the CPT code assignment in the U.S. further confirm its clinical utility. So when people say “OGM isn’t ready,” what they really mean is that FDA approval hasn’t caught up yet, not that the science is lacking. FDA clearance is a regulatory hurdle, not a scientific one. It requires formal submissions and manufacturing documentation, not just clinical brilliance. But when world-class institutions and global labs are already using OGM to replace outdated methods, it’s time to stop pretending this is experimental.
The science is in. What’s lagging is the bureaucracy.
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