WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
• BT-DX001 Mtb-specific antigen rCFP-10/Mtb-specific antigen rdESAT-6 Solution for injection 0.5 mcg per mL/0.5 mcg per mL - Serum Institute of India - INDIA
On 23 July 2025, the World Health Organization (WHO) prequalified the first antigen-based skin test for tuberculosis (TB) infection—marking a significant step forward for TB diagnostics. The product, Cy-Tb (SIILTIBCY), is manufactured by the Serum Institute of India Pvt. Ltd. using recombinant DNA technology and contains the TB-specific antigens rdESAT-6 and rCFP-10. This skin test is indicated as a diagnostic aid for the detection of Mycobacterium tuberculosis infection, including TB disease, in adults and children aged 28 days and older.
With this prequalification, Cy-Tb (SIILTIBCY), becomes eligible for procurement by United Nations agencies, The Global Fund, and national TB programmes—paving the way for broader and more equitable access to quality-assured TB diagnostics.
This milestone follows the recommendation by WHO’s Global Programme on TB and Lung Health to use antigen-based TB skin tests for detection of TB infection (WHO consolidated guidelines on tuberculosis: module 3: diagnosis). Rapid, accurate and sustainable identification of TB infection is crucial to prioritize individuals for TB preventive treatment (TPT)—helping to stop progression to active disease and preventing transmission within communities.
The prequalification of Cy-Tb underscores WHO’s ongoing commitment to expanding access to safe, effective, and affordable TB diagnostics in high-burden settings worldwide.