NEW YORK – Thermo Fisher Scientific announced on Friday that it has obtained clearance from the US Food and Drug Administration for two assays to assess risk of developing a severe pregnancy complication known as preeclampsia.
The PlGF plus and sFlt-1 assays run in 30 minutes on the BRAHMS KRYPTOR chemistry analyzer and are the first and only immunoassays to receive breakthrough designation and clearance from the FDA to assess risk and aid in clinical management of preeclampsia, the firm said in a statement.
Preeclampsia, a life-threatening blood pressure disorder, is the leading cause of maternal and fetal mortality and morbidity worldwide. Incidence rates for the condition have increased rapidly in the US, Thermo Fisher noted.
These new assays can be used along with other lab tests and clinical assessments to assess whether pregnant people who have been hospitalized for hypertensive disorders of pregnancy are at risk of progressing to preeclampsia with severe features within the subsequent two weeks.
"Today's clearance of these breakthrough biomarkers will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the US," said Alan Sachs, chief medical officer at Thermo Fisher Scientific.
The assays have been validated by a study, which examined more than 700 pregnant people in 18 hospitals. Patients who test positive based on a risk stratification ratio of the two assays could receive enhanced surveillance and accelerated care before severe features develop.
"Patients and providers will benefit from having better tests to predict progression to preeclampsia with severe features, especially for those patients at risk of severe, early-onset disease or for whom there is some diagnostic uncertainty," said Eleni Tsigas, CEO at the Preeclampsia Foundation. "Our organization celebrates this result after many years of advocacy with leaders in research and regulatory bodies, such as the FDA, to accelerate the development and adoption of better clinical tools."