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In a significant development for tuberculosis (TB) diagnostics, the European Medicines Agency (EMA) has recommended the marketing authorization of a new tool for detecting Mycobacterium tuberculosis infection. The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded on October 17 that the Siiltibcy skin test, manufactured by the Serum Institute of India, demonstrated favorable results in comparison to two existing diagnostic products.
How Siiltibcy Works The Siiltibcy test, based on rdESAT-6 and rCFP-10 antigens derived from M. tuberculosis, functions by inducing a delayed hypersensitivity reaction in individuals carrying the bacteria. Upon injection, the test causes skin thickening and hardening (induration) at the injection site in positive cases, with an induration of ≥ 5 mm signaling infection.
Tuberculosis is a respiratory disease primarily affecting the lungs, and according to the World Health Organization (WHO), 10.6 million people develop the disease annually. It remains one of the deadliest infectious diseases, claiming 1.6 million lives in 2021. Common TB symptoms include persistent cough, chest pain, weight loss, fatigue, and fever.
Comparison with Existing Tests Siiltibcy’s performance was evaluated against two established diagnostic tools: the Quantiferon TB Gold In-Tube test (an in-vitro diagnostic) and the intradermal Tuberculin Purified Derivative (PPD RT23) test. While Siiltibcy had slightly lower sensitivity than the PPD RT23 test, it outperformed in specificity, particularly in individuals who had been vaccinated with Bacillus Calmette-Guérin (BCG). The new tool produced fewer false positives by better distinguishing between M. tuberculosis infection and infections from other non-tuberculous mycobacteria.
Side Effects and Application Reported side effects from Siiltibcy were generally mild, with the most common being itching (pruritus), pain, and localized bruising (hematoma) at the injection site. The product will be available as a solution for injection containing 0.5 µg/ml of both rdESAT-6 and rCFP-10 antigens.
Siiltibcy is intended for use as a diagnostic aid for detecting M. tuberculosis infection in adults and children aged 28 days and older. It awaits final approval for marketing from the European Commission, with the application submitted by Serum Life Science Europe.
If granted approval, Siiltibcy could play a crucial role in enhancing TB detection, particularly in BCG-vaccinated populations, where traditional tests may yield less reliable results. This development offers hope for improved TB control as the global fight against the disease continues.
