Roche has received US Food and Drug Administration (FDA) 510(k) clearance for its Elecsys sFlt-1/PlGF ratio for preeclampsia testing.
The Elecsys sFlt-1/PlGF ratio is a prognostic test for assessing the progression of preeclampsia.
It is designed to stratify hospitalised pregnant women with hypertensive disorders into low- and high-risk categories for severe preeclampsia within two weeks of testing.
Early identification of high-risk patients allows for better prediction, timely interventions, and improved outcomes.
Preeclampsia is a multi-system complication of pregnancy that affects approximately 3% to 4% of pregnancies in the United States. It continues to impact maternal and perinatal morbidity and mortality worldwide.
sFlt-1 and PlGF are critical biomarkers involved in blood vessel formation during pregnancy. An imbalance between these biomarkers contributes to the development of preeclampsia. Their altered concentrations in maternal serum make them valuable for predicting its progression.
Roche Diagnostics North America president and CEO Brad Moore said: “There is a great need for highly reliable tools, such as the Elecsys sFlt-1/PlGF ratio, to address severe preeclampsia.
“We are eager to partner with our customers so this prognostic test can help clinicians plan care and improve patient outcomes.”
The Elecsys sFlt-1 and PlGF assays are provided in separate kits. The ratio is calculated using results from both assays on the same patient sample and the same cobas immunoassay analyser, per the intended use.
However, Roche stated that test results should complement clinical evaluations and standard procedures, rather than replace clinical judgment.
The preeclampsia ratio test will support Roche’s efforts to advance scientific innovation, delivering solutions that enhance patient outcomes and streamline laboratory operations.
With over 4,000 cobas analysers installed in the United States and a consolidated menu across multiple indications, Roche enables faster, more efficient clinical decisions.
The Swiss healthcare holding company said this extensive infrastructure will enable rapid scaling of testing, ensuring more women have access to critical care.
Recently, Roche received FDA approval for a label expansion of the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody.
