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Jul 5, 2012

Epistem’s TB Assay Achieves CE-IVD Certification

  • U.K. biotech firm Epistem achieved CE-IVD certification in Europe for its tuberculosis test run on the Genedrive™ platform. The 30-minute assay has been developed to provide what the firm claims is gold standard identification of Mycobacterium tuberculosis and antibiotic resistance. Epistem is in addition preparing regulatory submission for the test in India, and projects launching the TB test in the country toward the end of the year.

    In March the firm signed a sales and marketing deal for the TB test with Indian genomics firm Xcelris Labs, which will distribute the Epistem technology across India and the Indian subcontinent. This deal follows a collaboration agreement signed by the two firms in June 2011, through which Xcelris validated the Genedrive TB assay in comparison with existing TB methods in private clinics in India. 

    Epistem is exploiting expertise in the regulation of adult epithelial tissue stem cells to develop a therapeutic pipeline, and discover and develop biomarkers and diagnostics in the fields of cancer, gastrointestinal disorders, dermatology, and infectious diseases. The firm in addition operates a stand-alone preclinical contract research services business.

    Epistem’s therapeutic pipeline includes candidates against cancer and gastrointestinal diseases, which will be partnered out for clinical development. The firm’s Epistem Gene Expression Biomarkers division is leveraging its GenetRx™ gene-expression platform and PathwayDirect gene-expression database to identify and develop biomarkers from preclinical and clinical samples, both in house and through partnerships with industry.

    The most recent biomarker discovery collaboration, signed in March with GlaxoSmithKline, is focused on identifying key characteristics of diseased fibrotic tissue. The partnership is harnessing Epistem’s RNA-Amp™ amplification platform to provide gene-expression information from small tissue samples and low numbers of cells, such as those found at the base of single hair follicles. 

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