Epistem has announced the registration of its rapid molecular test for Tuberculosis (TB) test as a CE Marked in-vitro diagnostic medical device (CE-IVD).
The registration enables Epistem and/or its authorized representatives to place its TB test and Genedrive™ units for sale in the EEA member state markets.
Genedrive™ provides a major advance in next generation molecular diagnostic testing by providing a rapid (30 minute), low cost, simple to use 'Point of Care' device with high sensitivity and specificity.
Genedrive™ has applications across a wide range of bacterial, viral and fungal and somatic mutation disease status.
Genedrive™ will be targeted at providing 'gold standard' identification of Mycobacterium tuberculosis and antibiotic resistance testing and will be priced competitively with traditional less reliable methods of diagnosis such as microscopy and culturing.
The World Health Organization (WHO) has publicly recommended that nations incorporate new rapid molecular tests for tuberculosis into their disease testing programs.
On the back of this CE-IVD registration, Epistem 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 this year.
India has the largest number of TB sufferers in the world, more than twice the number in China, which has the second highest infection rate.
According to the WHO, every year 2 million new patients in India develop TB, with the highest incidence of fatalities occurring in remote rural areas.
Commenting on the successful registration of Epistem's first Genedrive™ test, Matthew Walls, CEO said "This is an important milestone for the Company as we move towards our first significant revenue stream in the commercialization of Genedrive™".