Clostridium difficile

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

The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month. 

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.

The Liat point of care system system has launched with four assays, including three respiratory tests and a novel test for Clostridium difficile.

The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument. 

The firm said that it has completed clinical trials for the Group B Strep assay for the FDA and will start trials for the C. difficile test this month.