The agreement covers the exclusive distribution of the AFIAS-10 single test immunoassay system, including IGRA-Tuberculosis, in 34 countries in Europe.

FLORENCE, Italy, April 19, 2023 /PRNewswire/ — 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 throughout Europe- of the AFIAS-10 integrated sample-response system, a fully automated diagnostic platform that can independently perform 10 different tests in parallel .

AFIAS-10 features an easy-to-use test procedure directly from blood collection tubes, with multi-test performance that provides fast results and enables rapid transmission of medical information. The all-in-one cartridge for the AFIAS platform is ready to use and contains all assay reagents. It is currently available for the measurement of more than 50 parameters.

IGRA-TB is a cytokine release assay for the quantitative determination of interferon gamma (IFN-?) produced by human blood cells stimulated with Mycobacterium tuberculosis (MTB) antigens. In particular, the AFIAS IGRA-TB test is a simple, rapid and cost-effective fluorescent immunoassay that can be used on the AFIAS-10 platform, an optimal solution for latent tuberculosis testing for a wide range of laboratory typologies.

Tuberculosis is one of the main causes of death in the world(1). According to the WHO, an estimated 10.6 million people contracted tuberculosis worldwide and a total of 1.6 million people died from this 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, Director 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 introducing to the EU market a highly innovative system for the IVD market. unique immunoassay tests, Afias-10 being a perfect fit for decentralized use with cost-effective positioning The platform’s assay portfolio includes tests of high medical value, such as the latent tuberculosis test AFIAS-10 distribution will benefit leveraging our strong sales and marketing forces deployed in the countries covered by the agreement.”

For more information, visit https://www.menarinidiagnostics.com/en-us/Home/Professional-Diagnostics/Immunochemistry/AFIAS-10/Features

References1. World report on tuberculosis 2022. Geneva: World Health Organization; 2022.2. European Center for Disease Prevention and Control, WHO Regional Office for Europe. Surveillance and monitoring of tuberculosis in Europe 2023 – Data 2021.

About Boditech Med Boditech Med Inc. has been developing in vitro diagnostic products and diagnostic reagents for 20 years. The Korea-based company has led the exploration of new markets by automating in situ immunodiagnostic devices and developing new high-sensitivity diagnostics.

About A.Menarini Diagnostics, the Human Touch of Technology For more than 45 years, the company has been dedicated to helping healthcare professionals make safe and sustainable diagnoses, improving the quality of life for people around the world.

A.Menarini Diagnostics is part of the Menarini Pharmaceutical Group, founded in 1886. Today it is present in 140 countries around the world, with more than 17,000 employees and a turnover in 2022 of 4,154 million euros.

For more information, visit: www.menarinidiagnostics.com and Linkedin.

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