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Posted On: 07/29/2025 3:42:53 PM
Post# of 85
OGM – Overcoming FDA’s stranglehold
Optical Genome Mapping (OGM) from Bionano Genomics has been adopted by leading research facilities across Europe, Asia, and Australia, enabling precise detection of complex structural variants at a scale and resolution previously unimaginable.
In clinical settings, hospitals and specialty clinics such as the Wellcome Sanger Institute, Children’s Hospital of Philadelphia, and University Medical Center Utrecht have leveraged OGM to refine diagnoses in hematological and rare genetic disorders, accelerating time to treatment and improving patient outcomes.
National health authorities in the United Kingdom, Japan, Switzerland, and Canada have issued administrative approvals for OGM platforms, integrating them into regulatory frameworks for diagnostics and patient care.
Despite these global successes, the U.S. Food and Drug Administration has imposed protracted review timelines on OGM systems, influenced by political pressures and entrenched commercial interests that prioritize incumbent technologies over patient-centered innovation.
Optical Genome Mapping (OGM) from Bionano Genomics has been adopted by leading research facilities across Europe, Asia, and Australia, enabling precise detection of complex structural variants at a scale and resolution previously unimaginable.
In clinical settings, hospitals and specialty clinics such as the Wellcome Sanger Institute, Children’s Hospital of Philadelphia, and University Medical Center Utrecht have leveraged OGM to refine diagnoses in hematological and rare genetic disorders, accelerating time to treatment and improving patient outcomes.
National health authorities in the United Kingdom, Japan, Switzerland, and Canada have issued administrative approvals for OGM platforms, integrating them into regulatory frameworks for diagnostics and patient care.
Despite these global successes, the U.S. Food and Drug Administration has imposed protracted review timelines on OGM systems, influenced by political pressures and entrenched commercial interests that prioritize incumbent technologies over patient-centered innovation.
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