The European Medicines Agency (EMA) has recommended granting marketing authorization for a new diagnostic tool for detecting Mycobacterium tuberculosis infection called Siiltibcy. The test uses antigens derived from M. tuberculosis to provoke a delayed skin reaction indicating infection. Tuberculosis is a major global health issue, with millions of people affected each year. Siiltibcy’s diagnostic accuracy was compared with other products, showing higher specificity for individuals vaccinated with Bacillus Calmette-Guérin. Common side effects include pruritus, pain, and hematoma at the injection site. The product is intended for use in adults and children over 28 days old and is awaiting final approval from the European Commission.
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EMA Recommends New Diagnostic Tool for TB
