Thermo Fischer Scientific has made a significant discovery by identifying new biomarkers, namely B•R•A•H•M•S PlGF plus KRYPTOR and B•R•A•H•M•S sFlt-1 KRYPTOR. These immunoassays have achieved breakthrough designation and clearance, making them the first and only tests to be approved for assessing the risk and managing preeclampsia.
Preeclampsia is an unsafe condition defined by elevated blood pressure that can manifest during pregnancy and postpartum. This condition stands as a primary contributor to the mortality and morbidity of both mothers and infants globally.
Notably, within the United States, the occurrence of preeclampsia has witnessed a swift escalation over the past ten years.
These newly created assays are intended to supplement conventional laboratory testing and clinical assessments. Their primary goal is to assist healthcare practitioners in assessing the risk of pregnant women hospitalized for hypertensive disorders of pregnancy. By integrating these tests, doctors can determine if these women are likely to develop severe preeclampsia during the next two weeks.
The PRAECIS study verified the efficacy of blood-based biomarkers, specifically B•R•A•H•M•S sFlt-1 KRYPTOR and B•R•A•H•M•S PlGF plus KRYPTOR, in detecting the onset of severe preeclampsia.
Thermo Scientific's B•R•A•H•M•S KRYPTOR compact PLUS clinical chemistry analyzer is intended to run these new assays. The analyzer, which uses TRACE technology, may provide results in less than 30 minutes.