Serum Institute of India's TB Detection tool rdESAT, rCFP-10 (Cy-Tb) use granted for 1 year age and above: CDSCO panel

New Delhi: Reviewing the clinical data of the comparative study of testing the efficacy and safety RdESAT-6 and rCFP-10 (Cy-Tb) injection, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Serum Institute of India's proposal for change in an indication of tuberculosis detection tool, rdESAT and rCFP-10 (Cy-Tb) injection for inclusion of age group 1 year and above.

This came after Serum Institute of India presented the proposal for a grant of permission for change in an indication of rdESAT and rCFP-10 (Cy-Tb) injection for inclusion of infants and above along with clinical trial data of the comparative study of testing the efficacy and safety of Cy-Tb with QuantiFERON-TB Gold Plus and 2 T.U. Tuberculin Purified Protein Derivative (PPD) RT23 SSI in the tube for detection of TB infection in children aged<1 year to 18 years.

The committee noted that Serum Inst. of India has been granted permission to manufacture and market drugs rdESAT and rCFP-10 (Cy-Tb) injection for the detection of Latent tuberculosis for the population of 18 years and above with condition to generate more clinical data in population less than 18 years of age for approval of Cy-Tb in this age group.

The Serum-Mylab Cy-TB Test, a fast and accurate diagnostic tool, represents a significant advancement in latent TB diagnosis. It combines the cost-effectiveness and simplicity of a skin test with the accuracy of the traditional high-cost lab-based test called interferon-gamma release assay (IGRA).

ESAT-6 is secreted through the ESX-1 secretion system (Type VII) of M. tuberculosis and has been implicated in mediating mycobacterial cytosolic translocation within the host macrophages by rupturing the phagosomal membranes.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal for a grant of permission for change in an indication of rdESAT and rCFP-10 (Cy-Tb) injection for inclusion of infants and above along with clinical trial data of the comparative study of testing the efficacy and safety of Cy-Tb with QuantiFERON-TB Gold Plus and 2 T.U. Tuberculin Purified Protein Derivative (PPD) RT23 SSI in the tube for detection of TB infection in children aged<1 year to 18 years

After detailed deliberation, the committee reviewed the recommendations of the ICMR as presented by the representative of ICMR and recommended for grant of permission for change in indication of rdESAT and rCFP-10 (Cy-Tb) injection for inclusion of age group 1 year and above.

The committee also recommended that for populations below 1 year, the rdESAT and rCFP-10 (Cy-Tb) injection should be used for the detection of latent TB in implementation research mode under the National program only.

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