Epistem plc
LSE : EHP

Epistem plc

April 23, 2015 07:42 ET

CORRECTION FROM SOURCE: Indian Approval of Import Licence for Genedrive® TB Molecular Diagnostic Test

MANCHESTER, UNITED KINGDOM--(Marketwired - April 23, 2015) -

This document corrects and replaces the press release that was sent today at 4:47:07 AM EDT

Epistem Holdings Plc (LSE:EHP), the personalised medicine and biotechnology company, announces today that the Drug Controller General of India (DCGI), Ministry of Health and family Welfare, Government of India has now issued a formal import licence to its Indian distribution partner, Xcelris Labs, for the import of Epistem's tuberculosis (TB) and antibiotic resistance test. The licence, 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, one of India's leading Genomics research and Diagnostic testing companies 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.

Commenting on the approval, Matthew Walls, CEO of Epistem said: "The Indian regulator's approval of our TB test represents a powerful endorsement of our strategy of developing Genedrive® for infectious diseases and our continuing strengthening focus on the TB market. We are now focused on obtaining Indian based KOL's to support the use and adoption of our device and assays. We see great potential for our TB test and its technical and commercial advantages for roll out in low income and developing countries in addition to the emerging potential for our Genedrive® platform in other disease areas."

About Genedrive®

Genedrive® (www.genedrive.com) 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. Genedrive® aims to provide a 'gold standard' for the identification of TB & antibiotic resistance. The World Health Organisation (WHO) has publicly recommended that nations incorporate new rapid molecular tests for TB into their disease testing programs. In addition to preparing for launch in India, the Genedrive® device is also undergoing clinical testing in countries across the World after which regulatory submissions will be filed to enable a global access and further roll-out of the TB test.

Epistem's Genedrive® platform has applications across a wide range of nucleic acid (molecular) based tests covering bacterial, viral and fungal diseases and gene somatic mutations for which Epistem is developing a menu of diagnostic tests. Further details can be found at: www.genedrive.com and www.epistem.co.uk

Contact Information

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

    John Rylands: Finance Director
    ++44 (0)161 606 7258

    Peel Hunt LLP
    James Steel
    ++44 (0)207 418 8900

    Clare Terlouw
    ++44 (0)207 418 8900

    Walbrook PR
    Mike Wort
    ++44 (0)207 933 8780

    Anna Dunphy
    ++44 (0)207 933 8780