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Epistem, Xcelris Ink Deal in Preparation of TB MDx Test Launch

NEW YORK (GenomeWeb News) – Epistem today announced a sales and marketing deal for its rapid molecular tuberculosis diagnostic test with Xcelris Labs of India.

After clinical testing is completed Epistem plans to file for regulatory approval of the test in preparation of a commercial launch, the company said. Its first molecular TB test, based on its Genedrive platform, will also test for antibiotic resistance.
Genedrive is a hand-held, point-of-care molecular diagnostic device for applications in bacterial, viral, fungal, and gene mutation diseases. Epistem plans to develop the system as the "gold standard" for TB identification and antibiotic resistance testing. The company said it will price its test to be competitive with existing technologies that are less accurate and slower, such as microscopy and culturing.

India has the largest number of TB sufferers in the world, according to Epistem, citing statistics from the World Health Organization, with 2 million new TB patients every year. Following regulatory approval, Genedrive may be included as part of the Indian Revised National TB Control Program.

In June, Epistem and Xcelris announced a deal to evaluate Genedrive for the early detection of TB. Manchester, UK-based Epistem said in the fall that it raised $4.4 million to accelerate development of the Genedrive platform.