Updated on 25 April 2015
Import license has been granted for a period of three years
Singapore: Epistem Holdings Plc (EHP), UK-based personalized medicine and biotechnology company, has announced that the Drug Controller General of India (DCGI), Ministry of Health and Family Welfare, Government of India, has issued an import license to its Indian distribution partner, Xcelris Labs, for the import of Epistem's tuberculosis (TB) and antibiotic resistance test.
The license, 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.
Over the coming months, Epistem and Xcelris Labs will begin to place Genedrive and its TB and antibiotic resistance tests with selected Key Opinion Leaders (KOL's). Epistem and Xcleris Labs will work closely with the KOL's to train and carefully monitor the operation of the first Genedrive field-based units to ensure the rapid and accurate diagnosis of TB sufferers.
Genedrive is a rapid, low cost, simple to use 'Point of Care' device with high sensitivity and specificity for the diagnosis of infectious diseases. The company claims that Genedrive aims to provide a 'gold standard' for the identification of TB and antibiotic resistance.