In a significant step for global health, Serum Life Science Europe GmbH (SLS Europe) and the Dutch-based Bilthoven Biologicals have received a positive opinion for the novel TB skin test, SIILTIBCY, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
This endorsement represents a critical milestone for tuberculosis (TB) screening and prevention across Europe.
SIILTIBCY is set to address a longstanding challenge in TB diagnostics, including the influence of Bacille Calmette-Guérin (BCG) vaccination status on skin test results. SIILTIBCY produces accurate results regardless of BCG status, potentially enhancing screening accuracy and can accelerate the uptake TB preventive treatment (TPT) globally.
A novel TB skin test: a global health milestone
The final decision on market approval for SIILTIBCY is anticipated by the end of 2024 by the European Commission. Should the approval be granted, Bilthoven Biologicals, in collaboration with the Cyrus Poonawalla Group—comprising Serum Life Science Europe GmbH, Bilthoven Biologicals, and Serum Institute India—will begin importing, releasing, and marketing SIILTIBCY across the EU member states. The introduction of this test in Europe will make it the first of its kind on the continent, with potential to improve the reach and efficacy of TB preventive measures. The picture below shows the current approval status of this diagnostic test in the region.
As TB remains the world’s deadliest infectious disease, the new TB skin test has the potential to catalyze TB prevention efforts not only in Europe but also on a global scale. The World Health Organization’s 2024 Global TB Report highlighted an urgent need for improved TPT coverage, which, in 2023, remained well below target levels—21% for household contacts of people with TB and 56% for people living with HIV.
In the opinion shared by EMA’s CHMP: SIILTIBCY is indicated as a diagnostic aid for detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older.
With the arrival of SIILTIBCY, the hope is to increase the accuracy and availability of TB screening, which is expected to translate into higher TPT coverage rates and ultimately fewer TB infections and deaths locally and worldwide.
Partnerships in global health
This development also underscores the power of cross-border collaboration in tackling global health challenges. The Cyrus Poonawalla Group’s partnership across India, Germany, and the Netherlands exemplifies how international collaboration can produce innovations with worldwide impact.
Shared knowledge, resources, and strategic partnerships can drive health breakthroughs that benefit all.
For the Netherlands, this development marks yet another achievement in the nation’s investment in global health innovations. As the headquarters of Bilthoven Biologicals, the Netherlands is positioned to become a leader in distributing high-impact health solutions across Europe, contributing not only to European public health but to the worldwide fight against TB, antimicrobial resistance (AMR) and other cross-border health threats. By embracing and championing innovations like the novel TB skin test in the European Union (EU), SIILTIBCY, the Netherlands continues to underscore its commitment to addressing infectious diseases and advancing the frontiers of global health—a vision that will undoubtedly inspire further innovations and collaborations in the future.
KNCV Tuberculosis Foundation has decades worth of experience in conducting research on TB diagnosis and implementation research. In addition, KNCV has developed essential training materials for healthcare workers worldwide in performing and interpreting TB skin tests accurately, ensuring that TB infections are identified early and managed effectively. With the novel TB skin test development, and approval in the EU, KNCV foresees an opportunity for scale-up and wider dissemination to expand access to TB skin testing in resource-limited settings. As a long-lasting partner with local governments, international health organizations, and communities across the globe, we believe that through these efforts we can achieve our ultimate goal: a world free from TB and other infectious diseases.
Partner with us, together we can end TB!