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IntelliGenome Receives FDA Breakthrough Device Designation for CRISPR-TB Blood Test
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Fusion42 · 28 July 2026 · Fusion42 review
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.
This Wire brief sits within Fusion42's coverage of Diagnostics.
◆ ◆ The Wire takeaway
You now have a cleared pathway to market and FDA cover for a CRISPR diagnostic platform that can be adapted to any pathogen detectable in blood. The hard part—proving the technology works—is done; the commercial move is to license or acquire this platform for other infectious diseases where sputum or tissue collection is a barrier.
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1 source · 28 Jul 2026
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