FDAnews Device Daily Bulletin

Saladax Gets CE Marking for Cancer Assay

June 20, 2008

Saladax Biomedical has received CE Marking registration in the EU for its personalized chemotherapy management assay on the Olympus AU400 clinical chemistry analyzer.

The blood test allows European oncologists to see patients’ plasma levels and prescribe 5-fluorouracil (5-FU) dosing accordingly.

Results from a randomized Phase III study demonstrated that a majority of patients are overdosed or underdosed, which can result in severe toxicity, Saladax said. The assay aims to correct this dosing accuracy problem.