GENEVA: The Stop TB Partnership’s Global Drug Facility (GDF) announced today the expansion of its portfolio with the addition of the novel SIILTIBCY skin test for Mycobacterium tuberculosis (Mtb) infection. SIILTIBCY, manufactured by the Serum Institute of India (Pune, India) and marketed in India as Cy-Tb, is available for procurement by any country through GDF for only $1.50 per dose.
The SIILTIBCY skin test is part of a class of next-generation Mtb antigen-based skin tests that are recommended by WHO for detecting Mtb infection.
Unlike the traditional tuberculin skin test (Mantoux test), which can produce false positives due to cross-reactivity with BCG vaccination and nontuberculous mycobacteria, SIILTIBCY uses Mtb-specific antigens, offering improved specificity. Programs familiar with implementing tuberculin skin tests can relatively easily transition to the more accurate SIILTIBCY, as it shares similar procedures for intradermal injection and induration measurement by trained health care workers and requirements for cold chain. Skin tests do not require a laboratory, unlike interferon-gamma release assays (IGRAs), another class of WHO-recommended test for Mtb infection.
"Until now, high TB burden countries have struggled to find an affordable, accurate and feasible way to test for Mtb infection,” said Lucica Ditiu, Executive Director of the Stop TB Partnership.
Among all the targets set by the 2018 United Nations High-Level Meeting (UNHLM) on TB, the enrollment of household contacts aged 5 years and older on to TB preventive treatment (TPT) was the one that fell the furthest short of its goal: only 10% of the 20 million target was reached by 2022. The 2023 UNHLM on TB set an even more ambitious target: countries have pledged to enroll 30 million household contacts onto TPT by 2027.
Ditiu added, “Without testing, many household contacts of people with TB have understandably been hesitant to start TPT. Now that SIILTIBCY is available and at such a low price, we hope that countries will adopt the test so that people, including household contacts, will know their infection status and be able to make informed decisions.”
As SIILTIBCY is administered via an intradermal injection, its eligibility for procurement by GDF requires the test to meet a higher quality standard than an in vitro diagnostic test (IVD).
Following the recommendation of the GDF-led TB Procurement and Market-Shaping Action Team to add SIILTIBCY to the February 2023 Global Fund Expert Review Panel (ERP) Expression of Interest (EOI), SIILTIBCY in August 2024 became the first Mtb antigen-based skin test to be approved by the Global Fund’s ERP, and therefore eligible for procurement via GDF by all countries, including those using Global Fund financing.
“The prompt GF ERP review and approval following the August 2024 European Medicines Agency acceptance of key product data will expedite availability to countries who need this test and highlights the importance of advanced planning and collaboration across many partners, including the WHO Prequalification Programme, the Global Fund, Stop TB’s GDF, USAID, National TB Programmes, implementers, and civil society organizations” said Brenda Waning, Chief of Stop TB’s Global Drug Facility.
For more information about SIILTIBCY, including product characteristics and implementation considerations, see the Stop TB GDF Fact Sheet on SIILTIBCY and the GDF catalog. Information on how to order via GDF can be found on the Stop TB website.
The Stop TB Partnership is a unique United Nations-hosted entity based in Geneva, Switzerland, committed to revolutionizing the TB space to end the disease by 2030. The organization aligns more than 2,000 partners worldwide to promote cross-sectoral collaboration. The Stop TB Partnership’s various teams and initiatives take bold and smart risks to identify, fund and support innovative approaches, ideas, and solutions to ensure the TB community has a voice at the highest political levels and that all TB-affected people have access to affordable, quality, and people-centered care.
GDF is the largest procurer of TB medicines and diagnostics globally. GDF’s unique portfolio of services, including management and coordination of market activities for the full portfolio of TB products, strategic procurement and innovative logistics solutions, technical assistance and capacity building for TB programmes in better pharmaceutical management practices, and accelerated uptake of new TB tools, helps facilitate worldwide, equitable access to TB medicines and diagnostics. GDF is a team of the Stop TB Partnership.
