IntelliGenome Secures Colombian Approval for CRISPR-Based TB Test
Colombia’s National Institute for Food and Drug Surveillance has granted sanitary registration for the CRISPR-TB Blood Test, a move that signals a shift in local tuberculosis diagnostics. Houston-based IntelliGenome, the test's developer, simultaneously tapped Velez Lab as its exclusive distribution partner to roll out the technology across the country.
The regulatory green light, issued under registration number 2026RD-0009793, allows for the immediate importation and sale of the assay. Unlike conventional methods, the test detects cell-free DNA from the Mycobacterium tuberculosis complex directly from blood samples. This mechanism is designed to support both centralized laboratory environments and decentralized point-of-care settings, addressing a critical gap in regions where traditional diagnostics remain difficult to implement.
For Colombia, which faces a persistent public health challenge regarding TB, the partnership aims to integrate new tools into existing patient management strategies. Kurt Wehrle, Vice President of Partnerships at IntelliGenome, noted that the blood-based approach targets patients who are traditionally difficult to diagnose. Alvaro Velez, CEO of Velez Lab, stated that the technology provides clinicians with a necessary alternative to current screening protocols. The companies now plan to collaborate with local healthcare institutions to build clinical evidence for pediatric and extrapulmonary tuberculosis cases.
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