Epistem gets India approval for Genedrive

MANCHESTER-based biotech firm Epistem has won approval from the Indian government for its first molecular diagnostic test for Tuberculosis.

The Drug Controller General of India (DCGI), Ministry of Health and family Welfare, has now issued a formal import licence to its Indian distribution partner, Xcelris Labs, for the import of Epistem’s Tuberculosis (TB) and antibiotic resistance test branded Genedrive.
 
The licence, which has been granted for a period of three years, enables Xcelris Labs to import Epistem’s new molecular test subject to normal conditions for such a product.
 
Epistem and Xcelris Labs will now commence the process of preparing for the launch of Genedrive and the TB and antibiotic resistance test into the Indian and Indian-sub continent markets.
 
 Matthew Walls, chief executive of Epistem, said:“The Indian regulator’s approval of our TB test represents a powerful endorsement of our strategy of developing Genedrive for infectious diseases and our continuing strengthening focus on the TB market.
 
“We see great potential for our TB test and its technical and commercial advantages for roll out in low income and developing countries in addition to the emerging potential for our Genedrive platform in other disease areas.”