Roche Diagnostics has unveiled a diagnostic preeclampsia test, an important advance that can help women with milder forms of the disease to safely extend their pregnancies.
As a nephrologist, Ananth Karumanchi, MD, treated hypertension and kidney failure in pregnant women with a potentially life-threatening complication called preeclampsia. Clinically, the condition sneaks in with a spike in blood pressure, high protein in the urine and an unusual headache. In the mother, preeclampsia can lead not only to kidney failure, but also to brain seizures and death. It is cured by the removal of the placenta – childbirth – but often presents before a fetus can safely survive on its own. ""If she is really sick, you need to deliver the mother,"" Karumanchi says. As a physician-scientist, Karumanchi saw a big unsolved problem that complicates about five percent of all pregnancies. Preeclampsia tops the list of causes of prematurity in the United States, and is the leading cause of maternal death in developing countries. In a quintessential example of translational research, Karumanchi, together with collaborator Vikas P. Sukhatme, MD, PhD, made a leap that connected their ongoing work into how tumors grow their own blood vessels to preeclampsia. They considered the placenta as simply another model system of how angiogenesis could go awry, and set to probing placental tissue with molecular tools.This approach paid off. ""Normally there is a balance between angiogenic growth factors and inhibitors,” says Karumanchil. “In preeclampsia, too many inhibitors are made and spill into and destroy the mother's kidneys and liver."" Specifically, the team discovered that the imbalance of angiogenic inhibitor sFlt-1 was a major culprit, and that its rise in the mother’s blood was predictive of the onset of preeclampsia. Based on this novel discovery, Roche Diagnostics has unveiled a diagnostic preeclampsia test, an important advance that can help women with milder forms of the disease to safely extend their pregnancies. BIDMC’s TVO filed a series of patent applications based on Karumanchi’s insightful sFlt1 discovery in the spring of 2002, and in February 2005 start-up company Nephromics, LLC, was formed. Employing a strategy of licensing the patents non-exclusively to several large diagnostic companies, including Beckman Coulter, Roche Diagnostics, Abbott Pharmaceuticals and Siemens Healthcare Diagnostics, Nephromics ensured that there would be more “shots on goal” in getting the new preeclampsia diagnostic to patients. In an exciting development, the Roche preeclampsia test received the CE mark in Europe in the first quarter of 2009, and is currently available in European markets, as well as in Canada, Australia and some countries in South America.