Blood-Based CRISPR Test for Tuberculosis Gains Regulatory Approval in Colombia

Solutions that function in centralized laboratories and near-patient settings are particularly important as health systems work to close detection gaps. A new blood-based CRISPR test now has Colombian regulatory registration, enabling commercialization and distribution in the country.

IntelliGenome’s CRISPR-TB Blood Test Kit has received sanitary registration from Colombia’s National Institute for Food and Drug Surveillance (INVIMA), authorizing importation and sale under Registration No. 2026RD-0009793. In parallel, the company appointed Velez Lab S.A.S. as its exclusive distribution partner for Colombia. The long-term commercial agreement is focused on expanding access to innovative tuberculosis diagnostic solutions throughout the country.

The CRISPR-TB Blood Test is a molecular diagnostic designed to detect cell-free DNA from the Mycobacterium tuberculosis complex in patients with suspected disease. The platform leverages CRISPR technology to enable tuberculosis detection directly from blood samples. It supports both laboratory-based and point-of-care testing approaches, aligning with use in centralized facilities and decentralized care settings.

The regulatory clearance and distribution partnership are positioned to broaden availability of blood-based tuberculosis testing while supporting evidence generation for potential integration into screening, diagnostic, and patient management pathways. IntelliGenome and Velez Lab plan to collaborate with healthcare institutions, researchers, and public health stakeholders to advance clinical studies in pediatric tuberculosis, extrapulmonary tuberculosis, and other high-priority populations. These efforts are intended to build the data needed to inform implementation across diverse settings in Colombia.

“Tuberculosis remains a significant public health challenge in Colombia, and innovative diagnostic approaches are needed to support earlier detection. We believe CRISPR-TB's blood-based approach has the potential to expand access to tuberculosis testing, particularly for patients who are difficult to diagnose using conventional methods,” said Kurt Wehrle, Vice President of Partnerships & Strategic Alliances at IntelliGenome.

“We are excited to partner with IntelliGenome to bring the CRISPR-TB Blood Test to Colombia. We believe this innovative technology has the potential to enhance tuberculosis detection and provide clinicians with an important new diagnostic option,” said Alvaro Velez, CEO of Velez Lab.

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IntelliGenome
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