A.Menarini Diagnostics S.r.l. (Menarini) is pleased to announce an exclusive distribution agreement for the AFIAS-10 System and IGRA-TB Assay (among others), building on several years of fruitful collaboration with Boditech Med Inc. (Boditech) in Italy.

This agreement grants Menarini with immediate availability the exclusivity for the distribution - in 34 countries across Europe - of the integrated sample-to-answer system AFIAS-10, a fully automated diagnostic platform that can perform independently 10 different tests in parallel.

AFIAS-10 features an easy-to-use testing procedure directly from blood collection tubes with multi-testing performance that provides prompt results and allows the quick transmission of medical information. The all-in-one cartridge for the AFIAS platform is ready-to-use and contains all assay reagents. At present it is available for the measurement of over 50 parameters.
IGRA-TB is a cytokine release assay for quantitative determination of Interferon Gamma (IFN-γ) produced by human blood cells stimulated with Mycobacterium tuberculosis (MTB) antigens. In particular, the AFIAS IGRA-TB test is a simple, fast and cost-efficient fluorescent immuno-assay that can be used on the AFIAS-10 platform, an optimal latent tuberculosis testing solution for a large range of laboratories typology.

Tuberculosis is one of the leading causes of death globally⁽¹⁾. According to WHO, an estimated 10.6 million people contracted tuberculosis worldwide and a total of 1.6 million people died from the disease in 2021⁽¹⁾. In Europe, an estimated 230,000 people fell ill with tuberculosis in 2021 and, for the first time in two decades, the incidence rate is estimated to have increased by 1.2% compared to 2020⁽²⁾

Fabio Piazzalunga, Global Head of A. Menarini Diagnostics S.r.l., stated: "This agreement represents a great opportunity for our Company to contribute to the required efficiency of IVD services by bringing a highly innovative system for the immuno-assay single test market onto the EU market, being Afias-10 a perfect fit for decentralized use with cost effective positioning. The platform portfolio of assays includes tests with high medical value such as Latent Tuberculosis Testing. AFIAS-10 distribution will benefit from leveraging our strong sales and marketing forces deployed in the countries covered by the agreement".