Tuberculini is optimized to run on Thermo Fisher Scientific’s Ion GeneStudio S5™ System.

Clemedi has developed a next-generation sequencing (NGS) based test called Tuberculini, that can recognise resistance to all major therapeutic agents used to treat tuberculosis. The assay – which received a CE-IVD mark earlier this year – has been optimized to run on Thermo Fisher Scientific’s Ion GeneStudio S5™ System, leveraging its ease of use, high throughput, and rapid turnaround time to deliver results within 48 hours.

Tuberculosis (TB) is a contagious, airborne disease that is a major cause of poor health and one of the leading causes of death particularly in low and middle income (LMIC) countries. TB is curable and preventable. However, it is estimated by the World Health Organization (WHO) that one-fifth of newly diagnosed patients are infected with a form of TB that is resistant to the most commonly used therapeutic agents.

Molecular tests have revolutionized TB diagnostics and management. Currently available, rapid turnaround tests can detect Mycobacterium tuberculosis, the bacterium causing the disease and resistance against the main drug rifampicin. However, choosing the optimal therapy in the case of drug-resistant tuberculosis still requires time consuming bacterial culture, with results after 4-10 weeks. This can change with Tuberculini.

Tuberculini provides results within 48 h, directly from patient material (e.g. sputum), without requiring culture. It is an all-in-one test for species identification, genotyping, and resistance prediction. It detects drug resistance mutations for 12 antibiotics based on the 2021 WHO document “Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance” with an easy-to-use software. The test and the software are CE-IVD certified and are currently available to European customers.

About Clemedi AG

Clemedi AG was founded in 2019 to develop sequencing-based tests for infectious diseases. It has developed a technology platform combining targeted sequencing and advanced bioinformatics to provide actionable results directly from a patient sample. Tuberculosis is the first assay on this platform, which will be followed by sexually transmitted infections and hospital acquired infections.

About Thermo Fisher Scientific

Contact Clemedi AG:

Dr. Sebastian Dümcke, CEO

Clemedi AG, Wagistrasse 12, 8952 Schlieren, Switzerland