COVER STORY / ADVERTISING FEATURE


Tuberculosis diagnostics: a new biomarker, a new generation


How R-Biopharm is redefining the fight against tuberculosis with IP-10-based diagnostics.


PP April 2026


Volume 27 Issue 2


www.pathologyinpractice.com pp cover Apr26.indd 1


It kills quietly, systematically and worldwide. Tuberculosis (TB) is still the most common deadly bacterial infectious disease on earth. According to the Global Tuberculosis Report 2025 published by the World Health Organization (WHO), around 10.7 million people fell ill in 2024 alone, with 1.23 million losing their lives. TB is curable. The real problem lies


elsewhere: in reliable and accessible diagnosis. This is exactly where R-Biopharm comes in with a new generation of an innovative Biomarker IP- 10 for the detection of latent tuberculosis.


Global problem A quarter of the world’s population carries Mycobacterium tuberculosis latently. This means: no symptoms, no infection; but a permanent risk. If the immune system weakens control, for example through illness, HIV or immunosuppression therapy, the latent infection can become an active disease. Chains of infection are created. TB is spreading. The WHO has set the ambitious goal of eliminating TB worldwide by 2030. This


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IP-10 – the new generation of TB diagnostics


25/03/2026 09:25


goal can only be achieved if infections are detected early and treated consistently. However, it is precisely in regions with the highest burden of disease – sub-Saharan Africa, South Asia, parts of South America – where there is a lack of robust, mobile and affordable diagnostics. It is precisely this gap that R-Biopharm wants to close. For diagnosing TB infection, we have


relied for many years on interferon- gamma release assays (IGRAs) and older methods like the tuberculin skin test. These tools have served important purposes, but they also come with limitations well known to clinicians: borderline responses, reduced


performance in vulnerable cohorts, pre- analytical challenges and sometimes operational constraints in high-burden regions.


Biomarker IP-10 IP-10 (Interferon-gamma-induced protein 10) is not a new discovery. In fact, it is a well-established chemokine with more than 300 publications demonstrating its association with TB immunology and diagnostics. What is new is its adoption into a fully CE IVDR approved diagnostic system, making this biomarker accessible for routine laboratory use. From a biological perspective, IP-10


is compelling for several reasons. After antigen stimulation of lymphocytes with M. tuberculosis specific peptides such as ESAT 6 and CFP 10, downstream cells can release up to 100-fold higher concentrations of IP-10 compared to interferon-gamma. This stronger signal does not come from T cells alone. Other immune cells contribute as well, which helps explain the improved sensitivity in difficult cohorts. This is also the reason why IP-10


performs particularly well in vulnerable groups, a point strongly supported in the literature. Populations which frequently challenge IGRA assays include individuals living with HIV, individuals with renal diseases, immunosuppressed patients (including those on biologics), young children and pregnant women. Often this cohort shows more robust IP-10 responses. These are exactly the patients who need beter diagnostic tools, because the consequences of missed latent or active TB can be severe.


New benchmark for sensitivity The evaluation of IP-10 based testing has shown a remarkably consistent performance across different study setings. To assess sensitivity in a meaningful and clinically relevant way, analyses were intentionally conducted using patients with microbiologically confirmed active TB, since for latent TB there is, strictly speaking, no true diagnostic gold standard. This lack of a definitive reference is well known in the field and complicates the interpretation of conventional assays. For this reason, active TB cohorts provide the most reliable


Early and consistent tuberculosis detection is crucial to break chains of infection and eliminate the disease worldwide


Dirk Dressler, Head of Business Development and TB-Diagnostics, R-Biopharm AG 6 WWW.PATHOLOGYINPRACTICE.COM April 2026


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