Mylab Discovery Solution on Wednesday launched the first Made-in-India kit and automated devices for tuberculosis (TB) and multi-drug resistance detection. Mylab and Serum Institute of India are also launching a CyTB test for the detection of latent TB, which is highly prevalent in India and remains undetected.
The government has been scaling up efforts to eliminate TB by 2025, and committing resources and detecting TB early is critical to achieving this target, Hasmukh Rawal, co-founder and managing director, Mylab, said. The PathoDetect RT-PCR-based kit along with the Mylab Compact device system completely automates the testing of multiple samples within two hours and can scale up testing and surveillance of TB in the country, he said. The system eliminates the microscope and manual intervention, and speeds up the testing process, he said. It is a portable system that can be taken into the interiors of the country, he said.
Apart from detecting TB, the Mylab kit can simultaneously detect multi-drug resistance to Rifampicin and Isoniazid in a single test, Rawal said. Until now, India had to conduct two tests — one to detect TB first and a second to check drug resistance — and this was available only for one Rifampicin. The Mylab kit can also test for resistance for Isoniazid, the other commonly used drug for treating TB, Rawal said. The cost of the test would be around `650 and was similar to the existing test cost.
For latent TB cases, Mylab and Serum Institute of India have collaborated to work on a test where an intradermal injection is given to a person and watched for 24-48 hours for any swelling, which indicates the presence of tuberculosis. This test would be targeting close family members of TB patients and the local community. This test has received all approvals and would soon be commercialised, Rawal said.
Mylab has received regulatory approval from the CDSCO, TB Expert Committee and ICMRfor the kit and automated devices. The test kits have been designed to work in ambient temperatures compared to existing PCR options which need 2-8 degree cold storage. They also do not require any special infrastructure for operations and mobile vans have reported robust performance