HOUSTON and BOGOTÁ, Colombia, June 29, 2026 /PRNewswire/ -- IntelliGenome, Inc., a molecular diagnostics company advancing next-generation tuberculosis detection technologies, today announced that Colombia's National Institute for Food and Drug Surveillance (INVIMA) has granted sanitary registration for the CRISPR-TB Blood Test Kit, enabling commercialization of the test in Colombia. The registration was issued under INVIMA Registration No. 2026RD-0009793 and authorizes the importation and sale of the assay in the country.
In conjunction with the regulatory approval, IntelliGenome has appointed Velez Lab S.A.S. as its exclusive distribution partner for Colombia under a long-term commercial agreement focused on expanding access to innovative tuberculosis diagnostic solutions throughout the country.
The CRISPR-TB Blood Test is a blood-based 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 tuberculosis detection from blood samples through both laboratory-based and point-of-care testing approaches, reflecting IntelliGenome's vision of expanding access to tuberculosis diagnostics across centralized and decentralized healthcare settings.
Colombia remains one of the highest-priority tuberculosis markets in Latin America, with a growing need for innovative diagnostic approaches that can complement existing testing strategies and help improve patient access to earlier diagnosis.
"Tuberculosis remains a significant public health challenge in Colombia, and innovative diagnostic approaches are needed to support earlier detection," said Kurt Wehrle, Vice President of Partnerships & Strategic Alliances at IntelliGenome. "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."
"We are excited to partner with IntelliGenome to bring the CRISPR-TB Blood Test to Colombia," said Alvaro Velez, CEO of Velez Lab. "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 establish a foundation for expanding access to innovative blood-based tuberculosis testing in Colombia while generating the clinical evidence needed to support future integration into tuberculosis screening, diagnostic, and patient management strategies. IntelliGenome and Velez Lab plan to collaborate with leading healthcare institutions, researchers, and public health stakeholders to advance evidence generation in pediatric tuberculosis, extrapulmonary tuberculosis, and other high-priority populations.
IntelliGenome is a molecular diagnostics company focused on the development and commercialization of innovative CRISPR-based diagnostic technologies. The company's CRISPR-TB platform utilizes proprietary molecular detection technologies to identify tuberculosis from blood samples and is being evaluated globally through collaborations with clinical, academic, and public health partners. IntelliGenome is advancing both laboratory-based and near-patient testing solutions to expand access to tuberculosis diagnostics worldwide.
Velez Lab S.A.S. is a leading Colombian provider of laboratory technologies, medical devices, and in vitro diagnostic solutions serving clinical laboratories, hospitals, healthcare institutions, and research organizations throughout Colombia. For more than four decades, Velez Lab has focused on delivering innovative diagnostic technologies, technical expertise, and customer support across a broad range of laboratory disciplines. Through its commitment to technology, innovation, and service excellence, Velez Lab has become a trusted partner to laboratories and healthcare providers across the country.
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