Urine Test in Development to Detect Preeclampsia

A urine test to detect preeclampsia is being developed by a startup group at Yale University.

A Yale University group has received $100,000 to create a urine test that can detect preeclampsia (PE), a condition that affects pregnant women and their unborn children.

A woman may be at risk for PE when she has high blood pressure and proteins in her urine after about the 20th week of pregnancy. Normally, the urine is checked at every doctor’s visit. If protein is detected, a mom-to-be may be asked to complete a 24-hour urine test, which often occurs in the hospital. These hospital tests can incur thousands of dollars, just in order to rule out the disease. The urine tests can detect proteins in general, and not all proteins may be the result of PE. Early warning signs for PE include headaches, abdominal pain, shortness of breath, and confusion, but in many women there are few signs of a problem.

GestVision received the seed funding from the Yale Entrepreneurial Institute (YEI), which is jointly run by Yale, Connecticut Innovations, and First Niagara Bank to develop a more effective urine test. The money will be used to develop a commercially available prototype for use in the Ohio area and internationally. Irina Buhimschi, MD, the Director of the Center for Perinatal Research at Nationwide Children’s in Columbus, Ohio, found a way to more directly test for PE via the specific proteins that would be present in a mother’s urine. The technology is patent pending, held by Yale, and is licensed to GestVision to further develop the test.

The GestAssured Test is designed to be a cost-effective test that can take place in-office with immediate results. It only screens urine samples for proteins that would indicate PE, which include ceruloplasmin, immunoglobulin free light chains, SERPINA1, albumin, interferon-inducible protein 6-16, and Alzheimer’s β-amyloid, according to study results Buhimschi published in July in Science Translational Medicine. The test has already been done on 600 patient samples, and has been highly correlated to women who needed an early delivery due to PE, according to the press release.

PE can lead to seizures, coma, and death in the mother and mortality, learning disabilities, cerebral palsy, and blindness in the premature infant if left untreated. The researchers believe developing the test can significantly impact PE diagnosis domestically and worldwide, especially where mortality rates from PE are high. Though the disease is poorly understood, the researchers hope their test will help aid diagnoses for PE, which is the number 1 cause for premature births worldwide.