A CRISPR Blood Test to Find South Africa's 'Missing' TB Patients

JOHANNESBURG, South Africa – July 20, 2026 – In the global fight against tuberculosis, the biggest challenge is often not treatment, but detection. For every person diagnosed and treated, others remain invisible to the healthcare system, silently carrying and potentially spreading the disease. Today, a strategic partnership aims to bring a powerful new light to this shadow epidemic in one of its epicenters.

Houston-based biotech firm IntelliGenome, Inc. has appointed ILEX South Africa (Pty) Ltd. as the exclusive distributor for its CRISPR-TB® diagnostic test. This isn't just a standard business deal; it's the introduction of a paradigm-shifting technology into a country that is both a leader in TB research and a nation grappling with one of the world's highest TB burdens. The collaboration promises to directly support South Africa's ambitious national health strategies by providing a new tool to find the 'missing' TB cases that current methods overlook.

The Science of a Breakthrough

For decades, TB diagnosis has relied heavily on sputum samples—a method that is often difficult for children, the elderly, and those with advanced illness. Existing molecular tests, while a significant improvement, still struggle with samples containing low bacterial loads or with forms of TB outside the lungs (extrapulmonary tuberculosis, or EPTB).

IntelliGenome's CRISPR-TB® represents a fundamental shift. It is a molecular assay that detects the cell-free DNA of the Mycobacterium tuberculosis complex directly from a simple blood sample. This circumvents the challenges of sputum collection entirely. By harnessing the precision of CRISPR gene-editing technology, the test can identify minute fragments of bacterial DNA circulating in the bloodstream with remarkable accuracy. Recent studies on CRISPR-based TB diagnostics have shown sensitivity rates upwards of 93%, often outperforming established molecular tests, especially in paucibacillary cases where bacteria are scarce.

"The ability to use a blood sample is a game-changer for diagnosing TB in vulnerable populations," noted one public health diagnostics expert. "It opens the door for earlier and more frequent testing in clinics, especially for patients living with HIV, where TB diagnosis is notoriously complex, and for children, who often cannot produce a valid sputum sample."

This potential was recognized by the U.S. FDA, which granted CRISPR-TB a Breakthrough Device Designation in early 2025. The technology is not just a lab-based solution; IntelliGenome is also advancing near-patient, point-of-care versions, which could one day bring this high-tech diagnostic power to remote clinics with limited infrastructure.

A Critical Frontline in the War on TB

Nowhere is such an innovation more needed than in South Africa. The country faces a staggering TB burden, with an estimated incidence of 389 cases per 100,000 people and around 54,000 deaths in 2022. Compounding this, over half of all TB patients are co-infected with HIV, and the nation is also on the global list of high-burden countries for drug-resistant TB.

In response, the government has implemented aggressive strategies like the National TB Recovery Plan and the National Strategic Plan for HIV, TB, and STIs (2023-2028). A core pillar of these plans is finding the undiagnosed. In 2021 alone, an estimated 120,000 people with TB were not diagnosed or initiated on treatment. This diagnostic gap fuels ongoing transmission and preventable deaths.

By introducing a highly sensitive, blood-based test, the IntelliGenome-ILEX partnership directly addresses this national priority. "South Africa has consistently led the world in tuberculosis research and innovation," said Kurt Wehrle, Vice President of Partnerships & Strategic Alliances at IntelliGenome. "Together with ILEX, we look forward to supporting South Africa's efforts to improve TB detection and expand access to advanced molecular diagnostics."

A Strategic Alliance for Impact

Bringing a cutting-edge diagnostic from a US lab to clinics across South Africa requires more than just good science; it requires deep local expertise and a robust logistical network. This is the critical role of ILEX South Africa. Established in 1992, ILEX is a dominant force in the African diagnostics market, with a presence in 16 countries beyond South Africa.

With headquarters in Johannesburg and regional offices across the country, ILEX has a proven track record of supplying and supporting complex molecular diagnostic platforms for blood services, clinical laboratories, and research institutions. Their role in this partnership extends far beyond simple distribution. ILEX will navigate the regulatory approval process with the South African Health Products Regulatory Authority (SAHPRA), drive market development, provide essential technical support and training, and foster collaboration with the country's world-class TB researchers.

"We are pleased to partner with IntelliGenome to help advance blood-based tuberculosis diagnostics in South Africa," stated Shameera August, Chief Executive Officer of ILEX South Africa. "We look forward to working with clinicians, researchers, and healthcare institutions to expand access to CRISPR-TB throughout South Africa."

This partnership model—combining disruptive technology with established, on-the-ground expertise—is a crucial strategy for delivering lasting value and ensuring that medical innovations translate into improved lives. For IntelliGenome, it provides an immediate and credible pathway into a high-priority market. For ILEX, it adds a revolutionary tool to their portfolio that meets a pressing public health need. And for South Africa, it offers a tangible new weapon in its long and determined fight against a devastating disease.