Test optimizes screening of gastroenteritis-causing bacteria directly from stool samples
Espoo, Finland – Sept. 23, 2014 – Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the European launch of Amplidiag™ Bacterial GE, marketed as a CE-IVD product under the Directive 98/79/EC on in vitro diagnostic medical devices. CE marking follows the successful completion of a two-center performance evaluation study. The test optimizes stool sample screening processes by utilizing well-established qPCR technology for rapid qualitative detection of eight gastroenteritis-causing bacteria. In contrast to current routine practices, the test does not require pre-culturing of the sample, bringing both laboratory process benefits by substantially reduced need for cultures, as well as clinical benefits by providing early, clinically relevant information. The test’s rapid and comprehensive results enable timely, evidence-based patient management decisions, contributing to improved healthcare processes.