Thermo Fisher Scientific (NYSE:TMO) announced that the US Food and Drug Administration (FDA) has cleared its Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR immunoassays.
In a statement, the global leader in scientific solutions said its biomarkers received breakthrough designation and are the first of their kind to be cleared for the risk assessment and clinical management of preeclampsia, a life-threatening blood pressure disorder that affects pregnant women.
The newly-cleared assays are designed to aid in the risk assessment of pregnant women hospitalized for hypertensive disorders, according to the company, helping to determine the likelihood of these women progressing to preeclampsia with severe features within two weeks.
Thermo Fisher told shareholders that the clearance is a significant development for the prognosis and treatment of thousands of women at risk of preeclampsia in the US.
The blood-based biomarkers, B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR, have been validated by the PRAECIS study, involving over 700 pregnant women across 18 US hospitals.
The assays run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS analyzer, which provides rapid results in under 30 minutes, utilizing TRACE technology based on Nobel Prize-winning chemistry.
By using these biomarker tests, healthcare providers can detect the development of severe preeclampsia and offer enhanced surveillance and accelerated care before severe features develop.
Shares of Thermo Fisher were up slightly, around 0.4%, on Friday morning ahead of the start of trading.
Contact Angela at angela@proactiveinvestors.com
Follow her on Twitter @AHarmantas