Bionano Genomics’ OGM – FDA status Bionan
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Posted On: 07/07/2025 9:33:07 AM
Bionano Genomics’ OGM – FDA status
Bionano is describing a two-step regulatory approach:
1. Secure formal approval for today’s laboratory-developed tests
They have tests that are designed, validated and run entirely within certified clinical laboratories under federal laboratory quality rules. Bionano’s first priority is to submit those existing tests to the federal food and drug agency for official clearance as diagnostic products.
2. Move on to the next-generation instrument once those tests are approved
After their current tests gain formal clearance, Bionano will turn its attention to filing for approval of the newer, higher-capacity genome-mapping machine. By proving the agency’s requirements on their established workflows first, they build experience, documentation and credibility—making it smoother to secure approval for their next-generation platform.
Bionano is describing a two-step regulatory approach:
1. Secure formal approval for today’s laboratory-developed tests
They have tests that are designed, validated and run entirely within certified clinical laboratories under federal laboratory quality rules. Bionano’s first priority is to submit those existing tests to the federal food and drug agency for official clearance as diagnostic products.
2. Move on to the next-generation instrument once those tests are approved
After their current tests gain formal clearance, Bionano will turn its attention to filing for approval of the newer, higher-capacity genome-mapping machine. By proving the agency’s requirements on their established workflows first, they build experience, documentation and credibility—making it smoother to secure approval for their next-generation platform.
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