Epistem receives CE-IVD certification in Europe

The U.K. biotech company Epistem recently received European CE-in-vitro diagnostic certification for its Genedrive TB assay platform.

Epistem announced that it is preparing for regulatory submission of the platform in India, where it plans to launch the test later in 2012, according to

In March, Epistem signed a sales and marketing agreement for Genedrive with the Indian genomics company Xcelris Labs. Xcelris plans to distribute Epistem's technology across the Indian subcontinent. The two firms originally signed a collaboration agreement in June 2011.

Under the terms of the agreement, Xcelris validated the assay by comparing it against existing TB diagnostic methods in use in private clinics throughout India. India has the largest number of TB cases in world. More than two million cases are detected there every year.

Epistem will likely sign more partners for its diagnostic platform as a result of the recent certification because the test can now be sold across the entire European Economic Area, according to

"Genedrive has overcome the first key hurdle, and looks well set to continue to expand the menu, sign more commercial partners and maximize returns from a truly disruptive diagnostics innovation," Dr. Paul Cuddon, an analyst for Peel Hunt, said, reports. "Not only is Genedrive cheaper than peers, its technical specifications are better."