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Epistem Files for Regulatory Clearance in India for Handheld MDx Platform, TB Test


NEW YORK (GenomeWeb) — Epistem said this week that it has successfully completed a clinical evaluation of its Genedrive molecular diagnostics platform and completed a regulatory submission with the Drug Controller General of India for its first test for the diagnosis of tuberculosis and rifampin resistance.

London-based Epistem is now awaiting approval from the Indian regulator for a license to import and sell it's the TB assay, which is anticipated early in 2015.

The clinical evaluation study was completed over a four-month period that ended in September and involved the testing of 300 randomly referred and blinded pulmonary raw sputum TB patient samples, with each Genedrive test taking approximately an hour to complete.

The test results demonstrated 93 percent sensitivity and 94 percent specificity when compared to 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-resistant TB cases in India, Epistem said.

The company added that these levels of accuracy, speed to result, and simplicity of operation compare favorably with other non-molecular TB test methods such as culture and microscopy, as well as molecular tests. Genedrive, the company claimed, can deliver results faster at a reduced cost and in remote or non-laboratory settings, making it ideal for use in low-income and developing countries.

Epistem has now commenced clinical evaluation studies in Nigeria, South Africa, Uganda, and Brazil underpinned by funding from the Foundation for Innovative New Diagnostics, National Institute of Allergy and Infectious Disease, and Bill and Melinda Gates Foundation. These studies will build on the results from India to support a potential World Health Organization recommendation for the device and TB assay later this year.

Genedrive is a fully integrated, handheld, endpoint PCR system that weighs around a pound and has a footprint similar to that of a laptop computer.