A test that has shown the ability to diagnose pre-eclampsia from first trimester serum samples with 67% sensitivity

Three markers identified using proteomics with the potential to form the basis of an immunoassay-based point of care test

Background:

Pre-eclampsia is a leading cause of fetal and maternal morbidity and mortality affecting 5-10% of all births.  The condition is currently only detected after onset, by routine measurement of blood pressure in the third trimester. The ability to accurately predict patients at risk for this disease would be of great value, enabling close surveillance and dramatically reducing costs of antenatal care and neonatal intensive care.  In addition, there is evidence that suggests low-dose aspirin could reduce the risk of developing pre-eclampsia if taken from the first trimester.

Current biophysical technology (uterine artery Doppler) has achieved 45% sensitivity at 21-23 weeks whilst the most reliable biochemical tests show 34% sensitivity (16-18 weeks). This project presents a test performed in the first trimester, for identifying women with a high risk of developing pre-eclampsia. 

The Technology

Proteomic fingerprinting using mass spectrometric serum profiling coupled to pattern recognition methodologies is a powerful new approach for identification of diagnostic biomarkers.   The research group have used proteomic analysis to compare first trimester serum samples from patients how went on to develop severe or early on-set pre-eclampsia with those from normal pregnancies.  Initial analysis of the data suggests that the first trimester biomarkers identified have a 67% sensitivity for pre-eclampsia.   This compares with single markers that have been proposed that achieve between 30 and 60% sensitivity and uterine artery doppler which, when used in the first trimester, has sensitivity of 27%.   

Within the next 3 months, we plan to find the identity of the main predictive markers. Once the identity is known, it is envisaged that this test could be developed into an ELISA format, offering performance and economical improvements on currently available technology.

Early Stage

UK patent application 621369.8 was filed in November 2006

St George's are seeking a collaboration to develop this technology into a prototype test for validation