31. Oktober 2022
Clemedi AG releases Tuberculini, its first molecular test for drug-resistant tuberculosis
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
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Contact Clemedi AG:
Dr. Sebastian Dümcke, CEO
Clemedi AG, Wagistrasse 12, 8952 Schlieren, Switzerland