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Epistem Holdings Plc

Indian approval of import licence for Genedrive® TB molecular diagnostic test

MANCHESTER, UNITED KINGDOM, April 23, 2015) - 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 issued an 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.

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Epistem announces successful completion of Genedrive® Indian clinical trials and regulatory submission

Epistem Holdings Plc, the personalised medicine and biotechnology company, announced the successful completion of its Genedrive® Indian clinical evaluation study and the regulatory submission with the Drug Controller General of India (DCGI) of its first test for the diagnosis of Tuberculosis and Rifampicin antibiotic resistance (TB). Epistem is now awaiting approval from the Indian regulator for a license to import and sell its first major infectious disease assay for TB, which is anticipated early in 2015.

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Epistem announces collaborative agreement with Global Health Investment Fund I, LLC.

Epistem Holdings Plc (Epistem), the personalised medicine and biotechnology company, announced that it has entered into a collaborative funding agreement with the Global Health Investment Fund I, LLC (GHIF) to support the roll-out of its Genedrive® molecular diagnostic platform as the company's tuberculosis assay enters pivotal field trials in key developing world locations.

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