INVIMA Approves IntelliGenome’s CRISPR-TB Blood Test for Sale in Colombia

Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA, the National Institute for Food and Drug Surveillance) has granted sanitary registration to the CRISPR-TB Blood Test Kit, a molecular diagnostic for tuberculosis developed by IntelliGenome, clearing the test for commercial sale in the country.

The registration, issued under INVIMA Registration No. 2026RD-0009793, authorizes the importation and sale of the assay in Colombia.

Alongside the approval, IntelliGenome named Velez Lab S.A.S. as its exclusive distribution partner in Colombia under a long-term commercial agreement to expand access to the test across the country.

“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.” — Kurt Wehrle, vice president of partnerships and strategic alliances, IntelliGenome

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. It uses CRISPR technology to support detection from blood samples through both laboratory-based and point-of-care testing, which the company says can serve centralized and decentralized healthcare settings.

Colombia is among the higher-priority tuberculosis markets in Latin America, with continuing demand for diagnostic approaches that complement existing testing strategies and support 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 and 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.”

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.

“We are excited to partner with IntelliGenome to bring the CRISPR-TB Blood Test to Colombia,” said Álvaro Vélez, chief executive officer 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 companies said they plan to work with healthcare institutions, researchers, and public health stakeholders to generate clinical evidence in pediatric tuberculosis, extrapulmonary tuberculosis, and other high-priority populations, with the aim of supporting future integration into tuberculosis screening, diagnosis, and patient management.

IntelliGenome is a molecular diagnostics company focused on CRISPR-based diagnostic technologies. Its CRISPR-TB platform is being evaluated through collaborations with clinical, academic, and public health partners, and the company is developing both laboratory-based and near-patient testing.

Velez Lab S.A.S. is a Colombian provider of laboratory technologies, medical devices, and in vitro diagnostic products serving clinical laboratories, hospitals, healthcare institutions, and research organizations. The company has operated for more than four decades.