Pune-based startup Mylab has received CDSCO, TB Expert Committee and ICMR approval for first Made in India tuberculosis (TB) detection kit which simultaneously detects multiple drug resistance to Rifampicin (RIF) and Isoniazid (INH) in single test.
The kit named PathoDetect MTB RIF and INH drug resistance kit is a RT-PCR based kit for accurate detection and will be used with Mylab Compact device systems , which will allow completely automated testing of multiple samples within 2 hours.
Explaining how this kit gives better testing option for TB, Hasmukh Rawal, MD of Mylab said, “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 which does not need highly technical person to handle samples and reagents.”
Multicentre centre evaluation study and field feasibility testing studies were carried out for the “PathoDetect MTB RIF and INH drug resistance kits” & Compact device systems. The centres of trials included the most reputed TB research centres of India.
The test kits have been designed to work in ambient temperatures compared to existing PCR options which need 2-8 degree cold storage. Mylab Compact device systems do not require special infrastructure for operations and feasibility studies done on mobile van in rural areas indicate them to be very robust.
