Indian diagnostic company Mylab on Wednesday said that it has received the nod from the Central Drugs Standard Control Organisation (CDSCO), TB Expert Committee, and the Indian Council of Medical Research (ICMR) for its made-in-India kit that detects tuberculosis and multiple drug resistance to rifampicin and isoniazid through a single test.
The RT-PCR-based PathoDetect MTB RIF and INH drug resistance kit will be used with Mylab Compact device systems, which allow automated testing of multiple samples within two hours.
“This PathoDetect kit combined with Mylab Compact device platform will fill the current gaps in tuberculosis testing, a disease which caused more deaths every year than the Covid-19 second wave,” Mylab said in a statement.
Hasmukh Rawal, MD of Mylab, stated, “We are addressing several problems simultaneously here. First, being able to speed up testing by automated systems that can do multiple tests at one time. Secondly, there is scarce trained manpower for RT-PCR testing, which India can now overcome with fully automated system.”
The kit got approved after field trials and recommended by the TB Expert Committee under the aegis of ICMR. Multi-centre evaluation study and field feasibility testing were carried out at TB research centres, which evaluated it against the currently used diagnostic assays for tuberculosis, Mylab's statement read.
Rawal said that there is a huge problem of resistance to drugs when it comes to TB. Until now, India had to conduct two tests: to detect TB and to check drug resistance, that too, against one drug (rifampicin). "With Mylab’s PathoDetect kit, in a single test, patients can know their active TB infection as well as drug resistance to two most common drugs, isoniazid and rifampicin. This is a milestone moment in India’s TB testing," Rawal added.