Letter Sent to FDA druginfo@fda.hhs.gov To
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Posted On: 06/23/2025 4:18:00 PM
Letter Sent to FDA
druginfo@fda.hhs.gov
To the U.S. Food and Drug Administration,
I am writing to express deep concern over the continued lack of clinical approval for Optical Genome Mapping (OGM) technologies, such as those developed by Bionano Genomics. These tools are already in use at leading institutions like Johns Hopkins and MD Anderson, where they are helping researchers uncover structural variants that traditional methods often miss.
Patients with life-threatening diseases—especially rare cancers and genetic disorders—deserve access to the most advanced diagnostic technologies available. OGM has demonstrated its value in real-world research and translational settings. The delay in regulatory approval is not just a bureaucratic issue; it is a barrier to care.
I urge the FDA to prioritize a modernized, responsive framework that reflects the pace of genomic innovation. Patients cannot afford to wait for outdated processes to catch up with life-saving science.
The FDA replied: Thank you for contacting the Division of Drug Information (DDI), your email is very important to us. Due to the HHS restructuring, effective April 1, 2025, our response time may vary. Thank you for your patience.
druginfo@fda.hhs.gov
To the U.S. Food and Drug Administration,
I am writing to express deep concern over the continued lack of clinical approval for Optical Genome Mapping (OGM) technologies, such as those developed by Bionano Genomics. These tools are already in use at leading institutions like Johns Hopkins and MD Anderson, where they are helping researchers uncover structural variants that traditional methods often miss.
Patients with life-threatening diseases—especially rare cancers and genetic disorders—deserve access to the most advanced diagnostic technologies available. OGM has demonstrated its value in real-world research and translational settings. The delay in regulatory approval is not just a bureaucratic issue; it is a barrier to care.
I urge the FDA to prioritize a modernized, responsive framework that reflects the pace of genomic innovation. Patients cannot afford to wait for outdated processes to catch up with life-saving science.
The FDA replied: Thank you for contacting the Division of Drug Information (DDI), your email is very important to us. Due to the HHS restructuring, effective April 1, 2025, our response time may vary. Thank you for your patience.
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