The Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyser is used to run the blood-based assays. Credit: Tatiana from Pixabay.

The US Food and Drug Administration (FDA) has granted clearance for Thermo Fisher Scientific’s novel immunoassays to support the risk evaluation of a severe pregnancy complication called preeclampsia.

The company has received both breakthrough designation and clearance for B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR biomarkers for the risk evaluation and clinical management of preeclampsia.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Designed for use with other laboratory tests and clinical assessments, the new assays will enable the risk assessment of pregnant women who were hospitalised for hypertensive disorders of pregnancy.

The tests can assist in assessing the likelihood of pregnant women developing severe preeclampsia in the coming two weeks.

The Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyser, which can offer results within 30 minutes, is used to run both assays.

Thermo Fisher Scientific chief medical officer Alan Sachs said: “Thermo Fisher is committed to advancing diagnostic solutions for reproductive health as part of our broader mission to enable our customers to make the world healthier, cleaner and safer.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“Today’s clearance of these breakthrough biomarkers will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the US.”

The PRAECIS study, which was conducted across 18 hospitals in the US, analysed more than 700 pregnant women to validate the efficacy of blood-based biomarkers in detecting the onset of severe preeclampsia.

Emory University health affairs executive vice-president Dr Ravi Thadhani said: “FDA clearance and availability of these novel biomarker tests throughout the country will allow caregivers to better manage and potentially improve outcomes for both mothers and their newborns.”