India Approves Licence for TB Diagnosis

The Drug Controller General of India (DCGI), Ministry of Health and family Welfare, Government of India has granted a licence to its Indian distribution partner, Xcelris Labs, for the import of Epistem's tuberculosis (TB) and antibiotic resistance test. The licence, granted in April to Epistem’s Indian distributor Xceleris Labs for a period of three years, signalled the start of preparations for the launch of Genedrive(R) and the TB and antibiotic resistance test into the Indian and Indian-sub continent markets.

The products are to be tested by selected Key Opinion Leaders (KOL's), with both companies providing training and operations monitoring of the first Genedrive(R) field-based units to ensure the rapid and accurate diagnosis of TB sufferers.

Commenting on the approval, Matthew Walls, CEO of Epistem said: "The Indian regulator's approval of our TB test represents a powerful endorsement of our strategy of developing Genedrive(R) for infectious diseases and our continuing strengthening focus on the TB market. We are now focused on obtaining the support of Indian based KOL's to support the use and adoption of our device and assays. 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(R) platform in other disease areas."