Alere has presented positive results from PELICAN clinical trial,designed to assess the safety and efficacy of Triage placental growth factor (PlGF) blood test in diagnosing pre-eclampsia in women with suspected pre-eclampsia before 35 weeks gestation.
The UK-based, multi-center study, which has enrolled 625 women with suspected pre-eclampsia in their first clinic visit, will measure maternal plasma specimen for PlGF levels.
The study demonstrated that women presenting before 35 weeks gestation with high PlGF level, which is an important marker for placental and foetal well being, are correlated with low risk for required delivery in the next 14 days.
The company said women identified with a low PlGF level are believed to be at high risk for preterm delivery and can be treated if identified at early stages.
University of Oxford obstetric medicine professor and study investigator Christopher Redman said Pre-eclampsia is notoriously unpredictable and if left untreated, may lead to maternal organ damage, foetal growth restriction and, in some cases, foetal or maternal death.
"Reliable tests that can be used in the clinical setting, when pre-eclampsia is first suspected, would be a notable breakthrough in the management of this life-threatening condition," Redman added.
"The PELICAN data have demonstrated that PlGF testing before 35 weeks enables physicians to categorise women into low and high risk for disease progression and to adjust clinical management appropriately."
King's College London obstetrics professor and study investigator Andrew Shennan said, "At last, with the Alere Triage PLGF Test, we have a simple and reliable tool guiding clinicians to target women who will benefit from these interventions, whilst limiting unnecessary healthcare expenditures incurred by managing women at low risk for needing preterm delivery," Shennan added.