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.
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.
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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