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India's Xcelris to Market Epistem's POC MDx Test for Tuberculosis


London-based Epistem said this week that India's Xcelris Labs will market its Genedrive point-of-care molecular testing platform for early detection of tuberculosis.

Epistem is currently conducting clinical testing for its Genedrive TB test, which is designed to detect TB in patients and assess antibiotic resistance. Following this testing, Epistem will prepare regulatory submissions for the product. The company did not provide a timeline for commercialization.

The Genedrive platform features push-button operation and integrated data analysis, and uses a thin-walled consumable cartridge and fast thermal cycling technology to perform about 30 PCR cycles in as little as 17 minutes.

Epistem has said that Genedrive's size, speed, and low cost — the company has said it can manufacture an instrument for about $400 with a $0.50 consumable cartridge — makes it conducive to use in remote locations.

Epistem originally partnered with Xcelris in June 2011 to evaluate the Genedrive platform as part of India's Revised National Tuberculosis Control Programme, initiated in 1997 to ensure the rapid diagnosis and treatment of TB patients (PCR Insider, 6/30/11).

In April 2011, the company said that it had begun collaborating with undisclosed clinical labs and companies in the UK and US to beta test Genedrive (PCR Insider, 4/7/11).

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