Roche Elecsys sFlt-1/PlGF ratio for preeclampsia receives FDA 510(k) clearance, offering a fast and reliable way to predict the risk of developing severe preeclampsia

Original from: Roche

Roche announced today that the Roche Elecsys® sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the United States Food and Drug Administration (FDA). The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing. Identifying patients at high risk for severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.

In the U.S., preeclampsia has increased 25% in the last two decades and is a leading cause of maternal and fetal illness and death. Black women in particular experience higher rates of maternal and adverse fetal and neonatal outcomes than other racial and ethnic groups and are at greater risk for developing hypertensive disorders of pregnancy than other pregnant women.

sFlt-1 and PlGF are key biomarkers in the formation of blood vessels during pregnancy. However, an angiogenic imbalance of these key biomarkers has been proven to play an important role in the development of preeclampsia. Their concentrations in maternal serum are altered even before the onset of the disease, making them a valuable tool for predicting preeclampsia progression.4,5 Nearly 70% of women with a sFlt-1/PlGF ratio greater than 38 delivered their babies within two weeks.

Preeclampsia is defined as the new onset of hypertension and proteinuria after 20 weeks of gestation, or in the absence of proteinuria, new-onset hypertension and any of the following: thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or new onset of headache unresponsive to medication. Preeclampsia can be treated only by removal of the placenta at delivery. The clinical presentation of preeclampsia and the subsequent clinical course of the disorder can vary tremendously, making prediction, diagnosis and assessment of progression difficult.

Preeclampsia and its symptoms, such as headaches, visual changes, epigastric pain, and shortness of breath, have warning signs that are often overlooked and have devastating and lasting impact on mothers and babies if not properly managed. Impacts can include maternal organ damage and an increased risk of future heart failure, preterm birth and avoidable mental trauma. Hospitalization is typically recommended to evaluate the potential for progression to severe disease. Standard diagnostic markers for preeclampsia are often nonspecific and may not accurately predict the severity of the condition or associated adverse outcomes in the subsequent days and weeks.

The preeclampsia ratio aligns with Roche’s commitment to lead with science in order to develop transformational solutions that improve patient outcomes and simplify lab operations. Roche provides an unrivaled ability to scale access to testing at speed for those who need it most. With an extensive U.S. installation base of more than 4,000 cobas® analyzers and a high degree of menu consolidation across various indications, clinicians are supported in making faster, more efficient clinical decisions, providing the ability to scale testing at speed for even more women.

Source: Roche Elecsys sFlt-1/PlGF ratio for preeclampsia receives FDA 510(k) clearance, offering a fast and reliable way to predict the risk of developing severe preeclampsia