IntelliGenome Receives FDA Breakthrough Device Designation for CRISPR-TB Blood Test

IntelliGenome has received FDA Breakthrough Device Designation for a CRISPR-based blood test that detects tuberculosis cell-free DNA, eliminating the need for sputum collection and enabling diagnosis in vulnerable populations. The company is positioned to accelerate multicenter clinical trials in 2025 across the US, Mexico, and Germany.

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