Alere has reported positive results from a clinical trial of its placental growth factor (PlGF) blood test, designed for the diagnosis of pre-eclampsia in women suspected of it before 35 weeks gestation.
More than 625 women have with suspected pre-eclampsia have been enrolled in the the UK-based, multi-centre PELICAN study in order to measure PlGF levels with the PLGF test.
The Triage PLGF test measures maternal plasma specimen and delivers result within 15 minutes.
A woman identified with a low PlGF level is believed to be at high risk for preterm delivery and can be treated if identified at early stages, according to the company.
University of Oxford obstetric medicine professor and study investigator Christopher Redman said that pre-eclampsia was 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 a substantial number of cases were missed when studied through current diagnostic methods.
"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, while limiting unnecessary healthcare expenditures incurred by managing women at low risk for needing preterm delivery," Shennan said.
Image: A histomorphologic finding seen in gestational hypertension, a component of pre-eclampsia- in a micrograph. Photo: courtesy of Nephron.