EMA Recommends New Diagnostic Tool for TB
18 October 2024
A new diagnostic tool for detecting Mycobacterium tuberculosis infection should be granted a marketing authorization, the European Medicines Agency (EMA) has said.
On October 17, the EMA’s Committee for Medicinal Products for Human Use concluded that the Siiltibcy skin test showed favorable results compared with two other diagnostic products.
Manufactured by the Serum Institute of India, Siiltibcy’s active substances are the rdESAT-6 and rCFP-10 antigens derived from M. tuberculosis. When injected, they provoke a delayed hypersensitivity reaction in individuals carrying the bacteria. The reaction manifests as thickening and hardening (induration) of the skin at the injection site. An induration of ≥ 5 mm indicates M. tuberculosis infection.
Tuberculosis (TB) primarily affects the lungs. According to the World Health Organization, an estimated 10.6 million people develop TB each year, and 1.6 million died from it in 2021, making it the world’s top infectious killer. Common symptoms of TB include prolonged cough, chest pain, fatigue, weight loss, and fever.
Comparative Performance
The EMA committee compared Siiltibcy’s diagnostic accuracy with two other products intended for diagnosing the presence of the bacteria. These were the in-vitro test Quantiferon TB Gold In-Tube and the intradermal Tuberculin Purified Derivative (PPD RT23). Although Siiltibcy showed slightly lower sensitivity than PPD RT23, it demonstrated higher specificity in individuals vaccinated with Bacillus Calmette-Guérin. Additionally, Siiltibcy was found to produce fewer false positives by better excluding people infected by mycobacteria other than M. tuberculosis, the EMA said.
Side Effects
The most common side effects with Siiltibcy are pruritus, pain, and hematoma at the injection site.
The full indication for Siiltibcy is as a diagnostic aid for detection of M. tuberculosis infection, including disease, in adults and children aged 28 days or older. It will be available as a solution for injection containing 0.5 µg/ml rdESAT-6 and 0.5 µg/ml rCFP-10.
The applicant for Siiltibcy is Serum Life Science Europe. Final approval for marketing authorization is pending from the European Commission.
By Peter Russell
Source: Medscape
