The biotechnology and personalized medicine company, Epistem, has gained CE mark for its in vitro diagnostic medical device (CE-IVD), Genedrive Tuberculosis (TB) test.
Epistem said the registration enables to place its TB test and Genedrive units for sale in the EEA member state markets.
Rapid molecular Genedrive tests the samples of mycobacterium tuberculosis and provides results with in 30 minutes.
In addition to bacterial tests, Genedrive has applications across viral, fungal as well as somatic mutation disease status.
By gaining CE-IVD, the company is now preparing regulatory submissions for India in advance of the anticipated launch of its first molecular TB test including patient assessment for antibiotic resistance towards the end of 2012.
Epistem CEO Matthew Walls said, "This is an important milestone for the Company as we move towards our first significant revenue stream in the commercialization of Genedrive."