Clostridium difficile

The Québec-based firm launched the test, which detects the toxin B gene of toxigenic C. diff strains directly from stool samples, in the US today.

The deal covers all Amplidiag tests and the Amplidiag Easyinstrument, and represents Mobidiag's entry into the Baltic region, a company executive said. 

The agency cleared the automated qualitative IVD test last month for the detection of the toxin B gene of toxigenic Clostridium difficile.

The firm said that it is delaying clinical trials prior to its FDA submission of Verigene 2 for several reasons, including reducing cassette failure rates.

The firm's life science segment grew revenues 8 percent, but revenues from its diagnostics segment saw revenues retreated 4 percent. 

The fourth test for which the firm has received regulatory clearance this year takes aim at a common microbial cause of healthcare-associated infections.

PerkinElmer's subsidiary Wallac will now distribute the Amplidiag product line in Israel and in a number of countries in Africa.

The test can generate results in around 35 minutes from stool samples and requires no upfront nucleic acid extraction.

Analyses of Clostridium difficile isolates from hundreds of European hospitals led to clusters of apparent hospital-acquired cases and of infections with other potential sources.