IntelliGenome Launches CRISPR-TB Blood Test Following INVIMA Approval in Colombia
IntelliGenome Launches CRISPR-TB Blood Test
On June 29, 2026, IntelliGenome, Inc. announced significant progress in tuberculosis diagnostics as they received sanitary registration from Colombia's National Institute for Food and Drug Surveillance (INVIMA) for their innovative CRISPR-TB Blood Test Kit. This landmark approval allows IntelliGenome to officially commercialize their CRISPR-based blood test technology, marking a crucial advancement in the fight against tuberculosis in Colombia. The INVIMA Registration No. for this groundbreaking product is 2026RD-0009793, which facilitates its importation and sale within the vibrant Colombian market.
As part of this significant initiative, IntelliGenome has formed a strategic partnership with Velez Lab S.A.S., appointing them as the exclusive distributor of the CRISPR-TB Blood Test in Colombia. This long-term agreement is geared towards expanding access to state-of-the-art tuberculosis diagnostics across the country, especially in a region that grapples with high tuberculosis prevalence rates.
The CRISPR-TB Blood Test stands out as a blood-based molecular diagnostic that is engineered to detect cell-free DNA associated with Mycobacterium tuberculosis in individuals suspected of having the disease. By employing cutting-edge CRISPR technology, the test enables tuberculosis detection not only in laboratory settings but also at the point of care. This dual approach aligns with IntelliGenome’s vision to enhance accessibility to tuberculosis diagnostics, facilitating both centralized and decentralized healthcare solutions.
In Latin America, Colombia is recognized as a critical market for tuberculosis diagnostics, having a pressing need for innovative solutions that can augment existing testing strategies. Kurt Wehrle, Vice President of Partnerships & Strategic Alliances at IntelliGenome, stated, “Tuberculosis remains a significant public health challenge in Colombia, and innovative diagnostic approaches are needed to support earlier detection.” He added that the new blood-based testing methodology could improve access for patients who pose diagnostic challenges using traditional testing methods.
Alvaro Velez, the CEO of Velez Lab, expressed excitement about the partnership, emphasizing the potential for the CRISPR-TB Blood Test to transform tuberculosis detection strategies for clinicians working on the front lines.
The recent INVIMA approval and the collaboration with Velez Lab create a robust foundation for advancing innovative tuberculosis testing in Colombia. Both companies have outlined a collaborative approach that includes working alongside the leading healthcare institutions and public health stakeholders in order to generate clinical evidence that will support the integration of this blood-based test into existing tuberculosis screening and patient management frameworks.
In addition to bolstering detection methods, IntelliGenome and Velez Lab aim to enhance research efforts focusing on pediatric tuberculosis, extrapulmonary forms of the disease, and other high-priority populations requiring improved diagnostic capabilities.
About IntelliGenome
IntelliGenome is at the forefront of molecular diagnostics, dedicated to advancing CRISPR-based technologies for diagnosing various health conditions. The company's innovative CRISPR-TB platform represents a pivotal solution in the fight against tuberculosis, poised for evaluation through collaborative efforts with clinical and public health experts globally.
About Velez Lab
Operating for over four decades, Velez Lab S.A.S. is a respected Colombian provider of laboratory technologies and diagnostic solutions. They serve a wide array of healthcare providers, emphasizing innovative technologies and customer support across diverse laboratory disciplines.
In summary, the receipt of INVIMA approval for the CRISPR-TB Blood Test and the partnership with Velez Lab positions IntelliGenome as a key player in advancing tuberculosis diagnostics in Colombia. The focus now shifts towards enhancing accessibility and efficiency, addressing one of the world's most pressing public health concerns.