MHRA Approves Serum Institute’s SIILTIBCY TB Skin Test For UK Market

The Serum Institute of India has received a significant regulatory milestone with the UK’s MHRA granting marketing authorisation for its innovative tuberculosis diagnostic, SIILTIBCY. This approval follows a similar endorsement by the European Commission earlier this year, positioning SIILTIBCY as a next-generation TB skin test with enhanced sensitivity and specificity.

SIILTIBCY is designed to detect TB infection irrespective of prior BCG vaccination, addressing a long-standing limitation in traditional TB diagnostics. The test uses recombinant antigens rdESAT-6 and rCFP-10, which were classified as new active substances by the Committee for Medicinal Products for Human Use (CHMP).

Key highlights from the announcement include:  

• SIILTIBCY will be launched across the UK and other EU/EEA countries starting Q1 2025, subject to local logistics.
• The test is expected to improve early TB detection and support public health efforts in high-burden regions.
• It is part of Serum Institute’s broader strategy to expand its global footprint in infectious disease diagnostics.
• The approval reinforces the institute’s reputation for delivering high-quality, affordable healthcare solutions worldwide.

Sources: Serum Institute of India Press Release, MHRA Product Database, SIILTIBCY.com.