Positive CHMP Opinion for SIILTIBCY Tuberculosis Skin Test

Serum Life Science Europe GmbH (SLS Europe) and Bilthoven Biologicals (BBio) have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for their novel tuberculosis skin test, SIILTIBCY®. This test is set to be Europe's first offering to accurately detect TB, irrespective of BCG vaccination status.

The European Commission is expected to make a final decision on marketing approval by the end of 2024. The positive recommendation stems from significant manufacturing and clinical data demonstrating SIILTIBCY's accuracy and safety. The test's effectiveness has been validated in Phase 3 clinical trials across Europe and Africa, involving over 2,500 participants.

SIILTIBCY®, already marketed in India as Cy-Tb, will become available in EU Member States upon approval. SLS Europe will manage marketing authorization while BBio will handle import and distribution. This collaboration signifies a milestone for the Cyrus Poonawalla Group, marking their commitment to innovative TB solutions.