Belgian diagnostics firm Pronota said this week that it would be participating in an international consortium funded by €6 million ($7.6 million) through the European Union's Seventh Framework Program to validate and refine its protein biomarker tests for preeclampsia.
Named IMPROVED, for Improved Pregnancy Outcomes via Early Detection, the consortium plans to establish multicenter clinical studies of Pronota's preeclampsia test as well as a metabolomics-based preeclampsia test from Ireland-based firm Metabolomic Diagnostics.
Slated for four years, the project will establish a pregnancy biobank with blood samples collected from 5,000 first-time pregnant women from countries including the UK, Germany, Sweden, and the Netherlands. The project also calls for analyses by statisticians and economists to determine the clinical and economical validity of the tests.
The preeclampsia test is Pronota's lead product, and the company hopes to complete US Food & Drug Administration 510(k) submissions and EU CE mark submissions for it within the next two years.
In July, the company released data from a 300-patient validation study that showed the test identified 80 percent of women who developed preeclampsia leading to the birth of a pre-term baby (PM 7/13/2012).
"We are excited to be part of the consortium," Pronota CEO Katleen Verleysen said this week in a statement. "The IMPROVED clinical trial will allow Pronota to progress its proteomics based risk stratification test.”