Pune-based diagnostic kit manufacturer Mylab Discovery Solutions has launched India’s first indigenously developed Tuberculosis detection kit. The PathoDetect kit can also detect multiple drug resistance to Rifampicin and Isoniazid in a single test. TB is one of the biggest killers in India with 4.93 lakh deaths reported in 2020.
The company claims that the PathoDetect kit, combined with Mylab compact device platform, will fill the current gaps in TB testing. “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 a fully automated system, which does not need highly technical persons to handle samples and reagents,” Hasmukh Rawal, the MD of Mylab said.
The automated system also helps to carry out the testing process even in rural areas and mobile labs. The company said the test kits are designed to work in ambient temperatures compared to existing PCR options, which need 2-8 degrees Celsius cold storage. They claim that Mylab’s Compact device systems do not require special infrastructure for operations and feasibility studies done on a mobile van in rural areas indicate them to be very robust.
The company has recently received approvals from the Central Drugs Standard Control Organisation (CDSCO), TB Expert Committee and Indian Council of Medical Research (ICMR) for its kit. The PathoDetect MTB RIF and INH drug resistance kit is an RT-PCR-based kit and will be used with Mylab compact device systems to allow completely automated testing of multiple samples within 2 hours.
The approval has come after a multicentre evaluation study and field feasibility testing studies carried out by the National Jalma Institute of Leprosy and other Mycobacterial Diseases(JALMA), Agra, National Institute of Tuberculosis and Respiratory Diseases (NITRD), New Delhi, National Institute for Research in Tuberculosis (NIRT), Chennai, National Institute of Research in Tribal Health (NIRTH), Jabalpur, Regional Medical Research Center (RMRC), Bhubaneswar and Bhopal Memorial Hospital and Research Centre (BHMRC), Bhopal.
“There is a huge problem of resistance to drugs when it comes to TB. Until now, India had to conduct 2 tests: one to detect TB first and to check drug resistance – that against only one drug (Rifampicin). With Mylab’sPathoDetect kit, in a single test – patients can know their active TB infection as well as drug resistance to the two most common drugs - Isoniazid and Rifampacin - so that they take treatment that will actually work. This is a milestone moment in India’s TB Testing,” Rawal said.