Epistem has announced the signing of a sales and marketing agreement for its rapid molecular test for Tuberculosis (TB) with Xcelris Labs, one of India’s leading Genomics research and Diagnostic testing companies.
Following the completion of clinical testing, Epistem will prepare regulatory submissions in advance of the launch of its first molecular TB test including patient assessment for antibiotic resistance using its novel Genedrive™ platform.
Genedrive™ provides a major advance in next generation molecular diagnostic testing. It provides a rapid (less than 30 minutes), low cost, simple to use ‘Point of Care’ device with high sensitivity and DNA specificity.
This is applicable to a wide range of viral, bacterial, fungal and somatic mutation disease areas.
Genedrive™ will be targeted at providing the ‘gold standard’ for TB identification and antibiotic resistance testing and will be priced competitively with existing less accurate and slower 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.
Designed as a handheld device, Genedrive™ brings a new and disruptive approach to diagnostic testing across a broad spectrum of infectious diseases such as TB, Dengue Fever, HIV and a wide range of sexually transmitted diseases (STD’s).
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.
Xcelris will be the channel partner for distribution of the Genedrive™ technology across India and the Indian sub-continent.
Following regulatory approval, Genedrive™ will be positioned to be included as part of the Indian Revised National TB Control Program(RNTCP).