HOUSTON, Texas & BOGOTÁ, Colombia, June 29, 2026
IntelliGenome, Inc. has received sanitary registration approval from Colombia’s National Institute for Food and Drug Surveillance (INVIMA) for its innovative CRISPR-TB Blood Test Kit, marking a significant milestone in expanding access to next-generation tuberculosis (TB) diagnostics across Latin America. The approval, issued under INVIMA Registration No. 2026RD-0009793, authorizes the importation and commercialization of the blood-based molecular diagnostic assay in Colombia. Simultaneously, IntelliGenome announced the appointment of Velez Lab S.A.S. as its exclusive commercial distribution partner in Colombia through a long-term agreement aimed at accelerating nationwide access to advanced tuberculosis testing. The regulatory milestone strengthens IntelliGenome’s strategy of deploying CRISPR-based molecular diagnostics to improve early TB detection while supporting both centralized laboratories and decentralized point-of-care healthcare settings. With tuberculosis continuing to pose a significant public health challenge throughout Latin America, the approval positions the company to address unmet diagnostic needs using innovative blood-based testing technology.
CRISPR-TB Platform Expands Blood-Based Tuberculosis Detection
The CRISPR-TB Blood Test is a molecular diagnostic assay developed to detect cell-free DNA from the Mycobacterium tuberculosis complex using a simple blood sample. Unlike conventional tuberculosis diagnostic methods that often rely on sputum specimens, IntelliGenome’s platform applies CRISPR-based molecular detection technology to identify tuberculosis in patients who may be difficult to diagnose using traditional testing approaches. The technology has been designed to support both high-throughput laboratory testing and near-patient point-of-care applications, improving flexibility across different healthcare environments.
This blood-based diagnostic approach has the potential to enhance tuberculosis detection among patient populations where sputum collection is challenging, including pediatric patients, individuals with extrapulmonary tuberculosis, and other high-priority clinical groups. By combining advanced molecular diagnostics with the precision of CRISPR technology, IntelliGenome aims to improve diagnostic accessibility, accelerate earlier disease identification, and contribute to more effective tuberculosis management strategies in regions with high disease burden.
Strategic Partnership Strengthens Commercial Expansion in Colombia
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Alongside regulatory approval, IntelliGenome has entered into an exclusive long-term distribution agreement with Velez Lab S.A.S., one of Colombia’s leading providers of laboratory technologies, medical devices, and in vitro diagnostic solutions. Through this strategic collaboration, Velez Lab will oversee commercialization, distribution, technical support, and market expansion for the CRISPR-TB Blood Test throughout Colombia. The partnership leverages Velez Lab’s more than four decades of experience serving hospitals, clinical laboratories, research institutions, and healthcare providers across the country.
Together, the companies intend to work closely with leading healthcare organizations, academic researchers, and public health stakeholders to generate additional clinical evidence supporting the use of blood-based CRISPR diagnostics in tuberculosis screening, diagnosis, and patient management. The collaboration will also focus on expanding evidence generation in pediatric tuberculosis, extrapulmonary tuberculosis, and other patient populations where improved diagnostic solutions remain critically needed.
Approval Supports Global Expansion of CRISPR-Based Diagnostics
The INVIMA approval represents an important commercial and regulatory milestone for IntelliGenome’s global expansion strategy, reinforcing the growing role of CRISPR technology in molecular diagnostics beyond genetic medicine. Colombia remains one of the highest-priority tuberculosis markets in Latin America, creating significant opportunities for innovative diagnostic technologies capable of improving early detection and expanding access to testing. By combining regulatory approval with an established local distribution network, IntelliGenome is well positioned to support healthcare providers with advanced molecular diagnostic solutions while generating valuable real-world clinical evidence for future market expansion.
As countries continue investing in rapid, accurate, and minimally invasive infectious disease diagnostics, CRISPR-TB has the potential to complement existing tuberculosis testing strategies and improve patient outcomes through earlier diagnosis and treatment initiation. The latest milestone highlights IntelliGenome’s commitment to advancing next-generation molecular diagnostics while strengthening global efforts to combat one of the world’s most persistent infectious diseases.
Source: IntelliGenome press release
