Bionano & Diagens: OGM Breakthrough or IP Risk?
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Posted On: 05/08/2025 6:47:34 AM
Bionano & Diagens: OGM Breakthrough or IP Risk?
Optical Genome Mapping (OGM) has the potential to revolutionize cytogenetics, but if FDA regulations and industry resistance slow down its adoption in the U.S., it could open the door for other countries—including China—to capitalize on the technology.
Historically, China has been known for rapid biotech expansion, sometimes through aggressive intellectual property strategies, including reverse engineering existing innovations. If Chinese biotech firms accelerate clinical validation and integration of OGM while regulatory delays stall progress in the U.S., they could gain an edge in this revolutionary genomic field.
To prevent this, the U.S. needs:
• Faster regulatory approvals to ensure groundbreaking technologies aren’t held back.
• Stronger patent enforcement to protect against unauthorized replication.
• Investment in OGM infrastructure to expand clinical adoption before competitors take the lead.
If OGM proves its superiority over traditional cytogenetics, the pressure on regulatory agencies and industry leaders to embrace it will only grow. The AMA, FDA, political and industry leaders must recognize the urgency in securing U.S. dominance in OGM?
Optical Genome Mapping (OGM) has the potential to revolutionize cytogenetics, but if FDA regulations and industry resistance slow down its adoption in the U.S., it could open the door for other countries—including China—to capitalize on the technology.
Historically, China has been known for rapid biotech expansion, sometimes through aggressive intellectual property strategies, including reverse engineering existing innovations. If Chinese biotech firms accelerate clinical validation and integration of OGM while regulatory delays stall progress in the U.S., they could gain an edge in this revolutionary genomic field.
To prevent this, the U.S. needs:
• Faster regulatory approvals to ensure groundbreaking technologies aren’t held back.
• Stronger patent enforcement to protect against unauthorized replication.
• Investment in OGM infrastructure to expand clinical adoption before competitors take the lead.
If OGM proves its superiority over traditional cytogenetics, the pressure on regulatory agencies and industry leaders to embrace it will only grow. The AMA, FDA, political and industry leaders must recognize the urgency in securing U.S. dominance in OGM?
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