Genedrive Regulatory News (GDR)

RNS Press Release

For release: 13th April 2015: 7.00 AM

Indian Health regulator notification of import licence for Genedrive TB molecular diagnostic test  

Epistem Holdings Plc (LSE: EHP), the personalised medicine and biotechnology company, announces today that in preparation for the launch of its first molecular diagnostic 'Point of Care' product for Tuberculosis, that its Indian partner Xcelris Labs has on 13th April 2015 via the website (http://www.cdsco.nic.in/forms/list.aspx?lid=2012&Id=3) been made aware that the Director General of Health Services, Ministry of Health and family Welfare, Government of India, will publish an approval letter in respect of the licence to import Epistem's Genedrive® Tuberculosis and antibiotic resistance molecular diagnostic kit. 

A further update will be issued in due course on receipt of the formal approval letter.

For further details please contact:

Epistem Plc

Matthew Walls: Chief Executive Officer ++44 (0)161 606 7258

John Rylands: Finance Director

Peel Hunt LLP

James Steel ++44 (0)207 418 8900Clare Terlouw 

Walbrook PR

Mike Wort ++44 (0)207 933 8780Anna Dunphy

Notes for editors

Epistem is a personalised medicine and biotechnology company developing innovative diagnostics and biomarkers alongside providing contract research services to drug development companies.

Genedrive® provides a major advance in molecular diagnostic testing by providing a rapid, low cost, simple to use 'Point of Care' device with high sensitivity and specificity for the diagnosis of infectious diseases and for use in patient stratification (genotyping). Genedrive® aims to provide a 'gold standard' identification of Tuberculosis & antibiotic resistance. The World Health Organisation (WHO) has publicly recommended that nations incorporate new rapid molecular tests for Tuberculosis into their disease testing programs. The Genedrive® platform and its first Tuberculosis test is now being prepared for launch in India and the Indian sub-continent. Genedrive® is undergoing clinical studies in countries across the World after which regulatory submissions will be filed to enable global access and roll-out of Epistem's first Tuberculosis test product. Further details can be found at: www.genedrive.com and www.epistem.co.uk