BNGO’s OGM & FDA’s Inertia When a technol
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Posted On: 06/21/2025 6:29:40 AM
BNGO’s OGM & FDA’s Inertia
When a technology like Bionano’s Optical Genome Mapping (OGM) is embraced globally, with mounting clinical evidence and real-world impact, it’s fair to ask: why hasn’t the FDA moved faster?
There’s no official statement from the FDA denying OGM or citing political reasons. But some observers and stakeholders have speculated that bureaucratic inertia, entrenched diagnostic paradigms, or even geopolitical dynamics may be slowing the process. For example, while China’s regulatory body has approved OGM for clinical use in reproductive health, the U.S. has yet to follow suit—even as researchers from France, Germany, Spain, and Brazil continue to validate its clinical utility.
This isn’t just about red tape—it’s about patients waiting for answers. And when a tool like OGM can detect structural variants that traditional methods miss, the stakes are deeply personal.
For patients with rare diseases, unresolved neurodevelopmental delays, or undiagnosed hematologic cancers, this isn’t just about better science—it’s about getting a real answer after years in limbo.
When a technology like Bionano’s Optical Genome Mapping (OGM) is embraced globally, with mounting clinical evidence and real-world impact, it’s fair to ask: why hasn’t the FDA moved faster?
There’s no official statement from the FDA denying OGM or citing political reasons. But some observers and stakeholders have speculated that bureaucratic inertia, entrenched diagnostic paradigms, or even geopolitical dynamics may be slowing the process. For example, while China’s regulatory body has approved OGM for clinical use in reproductive health, the U.S. has yet to follow suit—even as researchers from France, Germany, Spain, and Brazil continue to validate its clinical utility.
This isn’t just about red tape—it’s about patients waiting for answers. And when a tool like OGM can detect structural variants that traditional methods miss, the stakes are deeply personal.
For patients with rare diseases, unresolved neurodevelopmental delays, or undiagnosed hematologic cancers, this isn’t just about better science—it’s about getting a real answer after years in limbo.
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