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Import License Approved in India for Epistem's TB MDx

NEW YORK (GenomeWeb) – Epistem today announced the government of India has issued a three-year import license to the firm's Indian distribution partner, Xcelris Labs, for its molecular tuberculosis and antibiotic resistance test.

The test runs on Epistem's point-of-care Genedrive molecular diagnostics platform, described as a one-pound integrated, handheld, endpoint PCR system with a footprint similar to that of a laptop computer.

Manchester, UK-based Epistem announced completion of regulatory submission for the Genedrive TB test in India last October. At that time, Epistem had just finished a clinical evaluation of TB patient samples, demonstrating 93 percent sensitivity and 94 percent specificity when compared to culture.

Epistem CEO Matthew Walls said in a statement that the company is now focused on obtaining the support of India-based key opinion leaders to support the use and adoption of its device and assays.

"We see great potential for our TB test and its technical and commercial advantages for rollout in low-income and developing countries in addition to the emerging potential for our Genedrive platform in other disease areas," he said.

India has the largest number of TB sufferers in the world. The Asian Pacific geographical markets accounted for over 35 percent of the overall TB testing market in 2013, a market that is expect to reach an estimated value of $2.62 billion in 2020.

Epistem and Xcelris Labs plan to launch Genedrive and the TB and antibiotic resistance test into the Indian and Indian-sub continent markets in the coming months, focusing on training and monitoring the operation of the first Genedrive field-based units with KOLs.

Epistem is also developing a menu of molecular diagnostic tests for bacterial, viral, and fungal diseases, and somatic mutations, using the Genedrive platform. Previously, the company described ongoing clinical evaluations in Nigeria, South Africa, Uganda, and Brazil that were supported by the Foundation for Innovative New Diagnostics, the National Institute of Allergy and Infectious Disease, and the Bill and Melinda Gates Foundation.