OR14

1:Serum Institute of India; 2:Serum Life Sciences Europe; 3:Bilthoven Biologicals

Tuberculosis (TB) remains a leading cause of death globally. Over the past decade, Europe has fallen short of meeting the WHO End TB Strategy goals, highlighting the need for more specific and sensitive diagnostic tests. SIILTIBCY, also known as Cy-Tb, is a novel skin test that employs two Mycobacterium tuberculosis-specific recombinant proteins, rdESAT-6 and rCFP-10. This test was evaluated for safety and efficacy in seven clinical trials, comparing its diagnostic performance to PPD and QFT.

Based on pooled data the sensitivity of SIILTIBCY (76.8% [72.6-81.1]) was higher than QFT (68.0% [64.0-72.0]) and slightly lower than PPD (85.2% [81.6-88.8]) in a microbiologically confirmed TB-positive population. Specificity (92.8% [90.2-95.5]) was similar to QFT (89.5% [86.3-92.6]) and PPD (90.7% [87.5-93.9]) in a TB-negative population. In the pediatric population, SIILTIBCY outperformed QFT in specificity (83.2% vs. 71.7%), particularly in BCG-positive children (85.2% vs. 72.3%), offering a blood draw-free diagnostic tool for this vulnerable group. SIILTIBCY demonstrated high post-test probabilities and low false negatives, confirming its robustness in real world scenarios. Aside from a higher frequency of mild to moderate injection site hematomas, safety profiles of SIILTIBCY and PPD were equivalent .

SIILTIBCY's use of distinct antigens rdESAT-6 and rCFP-10, along with a fixed induration threshold, ensures reliable TB detection across diverse populations, including those with unknown BCG status, unlike PPD. With European Commission's marketing authorization granted in January 2025, SIILTIBCY provides the field-friendly approach of PPD while delivering IGRA-like performance, and can contribute to TB programmes across Europe.