Research & Development
Thermo Fisher Scientific receives FDA clearance for breakthrough preeclampsia immunoassays
19 May 2023 -

Thermo Fisher Scientific Inc (NYSE:TMO), a provider of science services, said on Friday that the US Food and Drug Administration (FDA) has cleared its B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR immunoassays.

These blood-based biomarkers are the first of their kind to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

Preeclampsia poses significant risks to maternal and foetal health, with increasing incident rates in the United States. The new assays, used in conjunction with other tests and assessments, aid in the risk assessment of pregnant women hospitalised for hypertensive disorders, helping to identify those at risk of progressing to preeclampsia with severe features within the next two weeks.

The assays, running on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyser, provide rapid results in less than 30 minutes, utilizing TRACE technology based on Nobel Prize-winning chemistry.