The Yale startup GestVision has created a simple urine test that studies show can provide accurate detection of a potentially devastating health condition known as preeclampsia (PE). The startup recently received $100,000 in seed funding from the YEI Innovation Fund, a fund run jointly by Yale, Connecticut Innovations and First Niagara Bank.
Preeclampsia impacts one in 12 pregnancies in the U.S. and puts tens of thousands of pregnant women and their unborn children at risk of death or serious health complications each year, yet the medical community is still waiting for a test that can provide accurate diagnosis. A pregnant woman is suspected of having preeclampsia when she has high blood pressure coupled by protein in the urine, usually after the 20th week of pregnancy. A pregnant woman’s blood pressure and urine is checked at every doctor’s visit. If protein is detected, a mom-to-be may be asked to do a 24-hour urine test, often in the hospital, incurring thousands of dollars in medical costs, in order to rule out preeclampsia.
The problem with current urine tests is that they detect proteins in general —although not all proteins may be the result of PE. Dr. Irina Buhimschi, Director of the Center for Perinatal Research at Nationwide Children’s in Columbus, Ohio, discovered a more direct way to test for proteins specific to PE while a professor at Yale University School of Medicine. Her technology is patent pending, held by Yale and licensed to GestVision with whom she is a collaborator and advisor.
The GestAssured Test is a simple, cost-effective test that can be done in-office with immediate results. It tests only for misfolded proteins in urine that Dr. Buhimschi discovered are specific to preeclamspia (these findings were published in Science Translational Medicine in July 2014). “She’s run the test on over 600 patient samples and it’s highly correlated to women who need early delivery due to preeclampsia” says Wendy Davis, CEO of GestVision who began working with Buhimschi through the Technology Commercialization Program at the Office of Cooperative Research. Davis has an MBA from Yale School of Management and an extensive career in biotech and intellectual property, most recently at the Yale startup HistoRx (acquired by Novartis 2012).
Davis says money from the YEI Innovation Fund will help develop the commercial prototype of the tests in time for use in the clinical trials at Ohio State and internationally. Such a test has significant implications for diagnosing PE not only in the U.S. but in developing nations where fatalities from PE are high.
PE warning signs include headaches, abdominal pain, shortness of breath and confusion, although in many women there are few signs of a problem. If left untreated, preeclampsia can lead to seizures, coma and death; doctors must decide if it is necessary to deliver the baby early to prevent further risk to the mother’s health, leading to a host of potential complications for the premature infant, including mortality, learning disabilities, cerebral palsy and blindness. And PE is widespread—the leading cause of premature births worldwide, and the cause of 18% of maternal deaths. According to the Preeclampsia Foundation, in the U.S., approximately 10,500 babies die from preeclampsia each year and an estimated half a million die from PE worldwide.
Davis says ob-gyns have been very supportive of the GestAssured Test. “Preeclampsia is the condition they lose sleep over,” she says. Furthermore progress to find a cure has been hampered because the condition is poorly understood. “Like most diseases,” Davis adds, “you have to define it before you can treat it.”