In a major boost to global tuberculosis (TB) diagnostics, the Serum Institute of India Pvt. Ltd. (SIIPL), through its UK-based subsidiary Serum Life Sciences Ltd., announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation for SIILTIBCY®, a next-generation skin test designed to detect infection caused by Mycobacterium tuberculosis.
This authorization allows SIILTIBCY® to be used across the United Kingdom for adults and children, marking an important step toward more accurate and reliable TB detection.
A Smarter, More Specific TB Skin Test
Unlike conventional tuberculin skin tests that may react in people previously vaccinated with BCG, SIILTIBCY® is formulated using two highly specific recombinant proteins—rdESAT-6 and rCFP-10. These antigens are unique to TB bacteria, enabling clinicians to better distinguish true infections from vaccine-related responses.
The test is administered through a small intradermal injection on the forearm. After 48–72 hours, healthcare professionals measure the induration to confirm whether TB infection is present.
Strengthening Global TB Control Efforts
The MHRA’s approval follows earlier regulatory successes, including marketing authorisation in the European Union. With TB continuing to be one of the world’s most persistent infectious diseases, early and accurate diagnosis remains critical to preventing spread and improving treatment outcomes.
Serum Institute stated that SIILTIBCY® aims to support national TB programs, hospitals, and public health systems by offering a modern, more precise alternative to century-old skin testing methods.
Serum Institute of India is the world’s largest vaccine manufacturer by number of doses produced. Through Serum Life Sciences Ltd., the organisation continues to expand its global footprint with innovative biologics and diagnostic solutions.
