Serum Life Science Europe GmbH (SLS Europe) and Bilthoven Biologicals (BBio) have announced a groundbreaking development in tuberculosis (TB) diagnostics, following the European Medicines Agency’s (EMA) positive recommendation for SIILTIBCY®. Expected to receive final European Commission approval by the end of 2024, SIILTIBCY® will become the first TB skin test in Europe effective for individuals vaccinated with BCG. BBio will handle the import, release, and marketing across EU Member States once the final authorization is secured.
SIILTIBCY®’s performance across three Phase 3 trials involving over 2,500 participants has underscored its accuracy and safety, positioning it as a vital tool for TB diagnostics in Europe. This development aims to fill a longstanding diagnostic gap and boost global TB eradication efforts, according to Adar Poonawalla, CEO of Serum Institute of India.
Among the contributors to this mission is Mr Jayachandran Ramalingam from Kalasapakkam, part of the Serum Institute team advancing SIILTIBCY®’s success. This test stands as a transformative solution in TB detection, poised to impact millions across Europe and beyond.