Pharma Focus America

Thermo Fisher Scientific Secures FDA Clearance for Immunoassays Advancing Preeclampsia Risk Assessment

Thermo Fisher Scientific, a leading company in the field of scientific solutions, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for their immunoassays aimed at aiding in the risk assessment of preeclampsia. This breakthrough designation makes the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR immunoassays the first of their kind to receive FDA clearance for this purpose.

Preeclampsia is a serious complication characterized by high blood pressure during pregnancy and the postpartum period. It is a leading cause of maternal and fetal mortality worldwide, and incident rates have been rising in the United States.

These newly cleared immunoassays are designed to be used alongside other clinical assessments and laboratory tests to assist in the risk assessment of pregnant women who have been hospitalized due to hypertensive disorders of pregnancy. The goal is to identify those who may be at risk of developing preeclampsia with severe features within the next two weeks.

Thermo Fisher Scientific's Chief Medical Officer, Alan Sachs, emphasized the company's dedication to advancing diagnostic solutions in the field of reproductive health. He believes that the clearance of these breakthrough biomarkers will have a significant impact on the prognosis and treatment of thousands of women at risk of preeclampsia each year in the United States.

The immunoassays, B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR, were validated through the PRAECIS study, which involved more than 700 pregnant women across 18 hospitals in the United States. The study confirmed that the risk stratification ratio of the two assays (sFlt-1/PlGF ratio ≥ 40) can aid in the detection of severe preeclampsia, allowing for enhanced surveillance and accelerated care before severe features develop.

Medical professionals and caregivers welcome the FDA clearance of these novel biomarker tests, as they believe it will enable better management and potentially improve outcomes for both mothers and newborns. The tests will provide valuable information, especially for patients at risk of severe, early-onset preeclampsia or those with diagnostic uncertainties.

The immunoassays are designed to be run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer, which utilizes TRACE technology. This technology, based on Nobel Prize-winning chemistry, enables the delivery of results in less than 30 minutes.

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