Use of a new noninvasive test for the accurate early detection of preeclampsia is proposed as a tool to screen women during early stages of pregnancy. Preeclampsia affects 10% of the 4 million pregnancies in the U.S. each year and is the leading cause of maternal and neonatal medical complications and death. There is currently no means of detecting preeclampsia prior to onset of clinical symptoms in the third trimester. Preliminary results using an isoelectric focusing (IEF) assay demonstrated that levels of a subfraction of serum albumin could be used to accurately predict the onset of disease months prior to the appearance of symptoms. A new colorimetric test has the potential to provide the same screening accuracy without the cumbersome equipment or time consuming procedures of the IEF method. Analysis times employing a routine blood sample average 2 hours. Five hundred individual samples can easily be processed in half a day by a single laboratory technician. We propose to validate the accuracy and optimize the conditions of this new assay using frozen plasma samples collected from carefully monitored patient populations at several major medical centers. We believe this assay will revolutionize the area of maternal medicine.
The need for an early detection of preeclampsia is well established. The market potential for a test that could rapidly and accurately screen the yearly 4 million pregnancies at low cost would be sizable. Repetitive testing to monitor the progress throughout the pregnancy of women identified in the initial screen as preeclamptic would provide an additional market for this product. This test could also be used in research laboratories to detect early changes in maternal physiology leading to improved treatment and prevention of this disease.
