IntelliGenome receives regulatory clearance and partners with Velez Lab for distribution of its molecular diagnostic assay.
Colombia’s National Institute for Food and Drug Surveillance (INVIMA) has granted sanitary registration for the CRISPR-TB Blood Test Kit, allowing for the commercialization of the molecular diagnostic throughout the country. The registration, issued under INVIMA Registration No. 2026RD-0009793, authorizes the importation and sale of the assay.
In conjunction with the regulatory approval, IntelliGenome has appointed Velez Lab SAS as its exclusive distribution partner for Colombia under a long-term commercial agreement.
The CRISPR-TB Blood Test is a molecular diagnostic designed to detect cell-free DNA from the Mycobacterium tuberculosis complex in patients with suspected tuberculosis. The platform leverages CRISPR technology to support detection from blood samples through both laboratory-based and point-of-care testing approaches.
“Tuberculosis remains a significant public health challenge in Colombia, and innovative diagnostic approaches are needed to support earlier detection,” says Kurt Wehrle, vice president of partnerships and strategic alliances at IntelliGenome, in a release. “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.”
Colombia is considered a high-priority market for tuberculosis diagnostics in Latin America, with a need for testing strategies that can improve patient access to earlier diagnosis.
“We are excited to partner with IntelliGenome to bring the CRISPR-TB Blood Test to Colombia,” says Alvaro Velez, CEO of Velez Lab, in a release. “We believe this innovative technology has the potential to enhance tuberculosis detection and provide clinicians with an important new diagnostic option.”
The approval and partnership are intended to establish a foundation for expanding blood-based tuberculosis testing while generating clinical evidence for future integration into screening, diagnostic, and patient management strategies. IntelliGenome and Velez Lab plan to collaborate with healthcare institutions, researchers, and public health stakeholders to advance evidence generation in pediatric tuberculosis, extrapulmonary tuberculosis, and other high-priority populations.
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