Positive vote by the EMA for new tuberculosis skin test SIILTIBCY®
The European Medicines Agency (EMA) has issued a positive recommendation for the tuberculosis skin test SIILTIBCY®, developed by SLS Europe and Bilthoven Biologicals 1.
SIILTIBCY® represents an innovative diagnostic advance as it enables more specific detection of latent tuberculous infection (LTBI) in children and adults. This new skin test, developed over many years, uses ESAT-6 and CFP-10 as antigens and can therefore achieve a similarly high specificity as the blood test-based interferon-release assays (IGRAs). In several phase III studies in Africa and Europe, the safety and comparable efficacy to THT and IGRAs was determined in over 2500 participants 2,3.
As already known from the conventional skin test (THT), SIILTIBCY is applied intradermally and the induration is read after 48 to 72 hours. The result can then indicate whether a latent tuberculous infection is present or not, independently of a BCG vaccination. There is also no cross-reactivity to a large number of non-tuberculous mycobacteria. Depending on availability, durability and price, the new skin test could therefore represent an alternative, e.g. in the context of screening or environmental examinations.
Approval is expected to be granted at the end of 2024, which will make the product available in the EU. We will then provide further information on our website.
- https://www.ema.europa.eu/en/medicines/human/EPAR/siiltibcy#product-details
- Ruhwald M, Aggerbeck H, Gallardo RV, et al; TESEC Working Group. Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon γ release assay and the tuberculin skin test: a phase 3, double-blind, randomized, controlled trial. Lancet Respir Med. 2017 Apr;5(4):259-268.
- Aggerbeck H, Ruhwald M, Hoff ST, et al. C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial. PLoS One. 2018 Sep 24;13(9):e0204554.
