FDA clears immunoassays to assess risk of preeclampsia

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June 2023—Thermo Fisher Scientific announced the FDA has cleared the Thermo Scientific Brahms PlGF Plus Kryptor and Brahms sFlt-1 Kryptor novel biomarkers, both of which received breakthrough designation from the FDA.

The assays are designed to be used with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women who have been hospitalized for hypertensive disorders of pregnancy to determine if they are at risk of progressing to preeclampsia with severe features within two weeks after testing.

The assays are designed to run on the Thermo Scientific Brahms Kryptor Compact Plus clinical chemistry analyzer, which can deliver results in less than 30 minutes.