If you are a diagnostic company dealing with the low sensitivity of current TB tests—which only hit 35% in pleural TB—this project validates the IRISA-TB test that identifies immune responses for faster, more accurate results.
Rapid Same-Day Diagnostic Test for Extra-Pulmonary Tuberculosis in High-Burden Regions
Most TB tests look for the bacteria itself, but in some forms of the disease, there aren't enough bacteria to find. Instead of hunting for the germ, this test looks for the body's own immune response signals. It's like looking for smoke instead of the fire when the fire is too small to see.
What needed solving
Current TB tests fail in extra-pulmonary cases because bacterial loads are too low, leading to empiric treatments that cause unnecessary morbidity or delay cancer diagnosis.
What was built
A low-cost, same-day diagnostic test (IRISA-TB) that detects interferon-gamma to identify extra-pulmonary TB.
Who needs this
Who can put this to work
If you are a hospital operator dealing with the risk of treating patients for TB without a confirmed diagnosis, this project provides a same-day test to avoid unnecessary long-term medication and delayed cancer diagnosis.
If you are a distributor dealing with the lack of skilled pulmonologists for pleural biopsies, this project scales a low-cost, CE-marked test that can be used in high-burden settings without specialized surgical equipment.
Quick answers
What is the cost or price of the diagnostic test?
Based on available project data, the IRISA-TB test is described as a low-cost diagnostic tool, though specific pricing figures are not provided.
Is the technology ready for industrial scale?
Yes, the test is already CE marked, SAHPRA approved, and endorsed by the Global Fund, with the current project focusing on a large multicentric study of 2170 patients to facilitate WHO endorsement.
What is the IP or licensing status?
The test was developed by a South African university start-up; however, specific licensing terms are not detailed in the provided project data.
How does this integrate into current clinical workflows?
It provides a same-day result, replacing the need for slow TB cultures or invasive pleural biopsies that require specialized physicians.
What regulatory approvals has it already received?
The IRISA-TB test has already received CE marking and SAHPRA approval.
Who built it
The consortium is lean, consisting of 4 partners across 4 countries (NL, ZA, ZM, ZW). It is heavily weighted toward academic and research institutions (1 university, 2 research organizations, 1 other), with 0% industry representation. This suggests the project is focused on clinical validation and public health implementation rather than industrial manufacturing.
Contact the University of Cape Town Lung Institute PTY LTD
Talk to the team behind this work.
Contact us to explore licensing opportunities for the IRISA-TB diagnostic technology.