NEW YORK – Roche Diagnostics announced Thursday that its Elecsys sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the US Food and Drug Administration.
The prognostic test is 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.
SFlt-1 and PlGF are biomarkers for the formation of blood vessels during pregnancy, and an angiogenic imbalance of the biomarkers plays a role in the development of preeclampsia, Roche said in a statement. Concentrations of the two biomarkers are altered before the onset of the disease, which makes them "a valuable tool for predicting preeclampsia progression," Roche noted.
The assays are provided in separate kits, and the ratio must be calculated using Elecsys sFlt 1 and Elecsys PlGF results obtained on the same patient sample and same Cobas immunoassay analyzer. The test results are not intended to replace clinical judgment, Roche said.
"There is a great need for highly reliable tools, such as the Elecsys sFlt-1/PlGF ratio, to address severe preeclampsia," Roche Diagnostics North America President and CEO Brad Moore said in a statement. "We are eager to partner with our customers so this prognostic test can help clinicians plan care and improve patient outcomes."
Preeclampsia can cause maternal organ damage and an increased risk of future heart failure, preterm birth, and mental trauma.