Epistem’s molecular test for tuberculosis has received the CE mark, the company announced
. The rapid test is based on the biotechnology company’s Genedrive IVD platform and is the first successful registration of an IVD using the platform, according to the company. Genedrive is a POC test designed to diagnose viral, bacterial, fungal, and somatic mutations in less than 30 minutes. Following the announcement, Epistem said it is preparing to submit the test for regulatory approval in India, where more than 2 million cases of TB occur annually, according to the company.
UK-based Epistem specializes in the commercialization of adult stem cells for oncology, gastrointestinal, and cosmeceutical applications. The company says it uses stem cells found in epithelial tissue and does not conduct research using embryonic stem cells.