Successful Completion of Genedrive(R) Indian Clinical Trials and Regulatory Submission
LONDON, UNITED KINGDOM--(Marketwired - Oct 28, 2014) - Epistem Holdings Plc (EHP.L), the personalised medicine and biotechnology company, announces today 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.
The clinical evaluation study was completed over a 4-month period ending September 2014 and involved the testing of 300 randomly referred and blinded pulmonary 'raw sputa' TB patient samples, with each Genedrive® test taking approximately 1 hour to complete. The test results demonstrated high levels of sensitivity (93%) and specificity (94%), versus the industry gold standard 'culture test' method for TB. The study also measured those patients showing resistance to the first line antibiotic Rifampicin, a growing concern due to irregular and incomplete treatment with differing regimens giving rise to the growth in Multi Drug Resistance-TB (MDR-TB) cases in India.
These levels of accuracy, speed to result and simplicity of operation compare favourably with other molecular and non-molecular TB test methods, such as culture which has lengthy turn around times to test result (culture testing typically takes up to 42 days to obtain a confirmed TB test result), microscopy which delivers less accurate results (lower sensitivity and specificity) and other competitive molecular tests which can require lengthy upfront extraction processes, extended timescales to test result and/or increased cost. Genedrive's advantage is its ability to deliver an industry leading speed to result, high levels of molecular accuracy and simplicity of use at low cost in remote/non laboratory-based settings, making it suitable for tackling disease in low-income countries and developing nations.
India is the highest TB burden country in the world with World Health Organisation (WHO) statistics for 2011 giving an estimated incidence figure of 2.2 million cases of TB for India out of a global incidence of 8.7 million cases *. Our Indian distributor partner Xcelris Lab is preparing for the launch of our TB test including first line antibiotic resistance (Rifampicin) detection.
Genedrive® (http://www.genedrive.com) has now commenced clinical evaluation studies in Nigeria, South Africa, Uganda and Brazil underpinned by funding from the Foundation for Innovative New Diagnostics (FIND), National Institute of Allergy and Infectious Disease (NIAID) and the Bill and Melinda Gates Foundation (BMGF). These studies will build on our Indian results to provide a dossier of support targeting a World Health Organisation (WHO) recommendation for our Genedrive® device and TB assay anticipated later in 2015.
Matthew Walls, CEO of Epistem commented: "The successful completion of the Genedrive® Indian study and submission for regulatory approval marks a vitally important milestone in the development of our flagship technology and moves us a significant step closer to commercial sales of our first TB product into India and the Indian sub-continent".
* Global Tuberculosis Control 2012, WHO, Geneva, 2012 www.who.int/tb/publications/global_report/
Notes to Editors:
About Epistem
Epistem is a personalised medicine and biotechnology company commercialising its technology and expertise in the areas of infectious and epithelial disease (oncology, gastrointestinal and dermatological). Epistem develops innovative diagnostics and pharmacogenomics (Genedrive®), target discovery of novel therapeutics and contract research services for drug development companies. Epistem operates three divisions, Personalised Medicine (Diagnostics and Pharmacogenomics), Contract Research Services and Novel Therapies.
Genedrive® (http://www.genedrive.com) provides a major advance in next-generation molecular diagnostic testing by providing a handheld, rapid, low-cost, simple-to-use 'point of care' device with high sensitivity and specificity for diagnosis of infectious diseases. Genedrive® aims to provide a 'gold standard' identification of tuberculosis and antibiotic resistance. The World Health Organisation (WHO) has publicly recommended that nations incorporate new rapid molecular tests for tuberculosis into their disease testing programs.
Epistem's Genedrive® platform has applications across a wide range of bacterial, viral and fungal and somatic mutation diseases for which Epistem is developing a menu of diagnostic tests.
