We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Thermo Fisher Scientific

Thermo Fisher Scientific Inc. serves customers who are accelerating life sciences research, solving complex analytica... read more Featured Products: More products

Download Mobile App




Breakthrough Immunoassays to Aid in Risk Assessment of Preeclampsia

By LabMedica International staff writers
Posted on 10 Aug 2023
Print article
Image: The new assays are designed to run on the B•R•A•H•M•S KRYPTOR compact PLUS clinical chemistry analyzer (Photo courtesy of Thermo Fisher)
Image: The new assays are designed to run on the B•R•A•H•M•S KRYPTOR compact PLUS clinical chemistry analyzer (Photo courtesy of Thermo Fisher)

Preeclampsia is a life-threatening blood pressure condition that can arise during pregnancy and the postpartum phase. This severe pregnancy complication is a primary cause of maternal and fetal mortality and morbidity globally. In a significant advancement, two novel assays are now available for use with other lab tests and clinical evaluations to assist in evaluating the risk of pregnant women, already admitted for hypertension-related pregnancy disorders, developing severe preeclampsia within the upcoming two weeks.

Thermo Fisher Scientific Inc. (Waltham, MA; USA) has been granted clearance by the U.S. Food and Drug Administration (FDA) for its novel biomarkers, Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR. These are the first and only immunoassays to secure breakthrough designation and clearance for preeclampsia risk evaluation and treatment. The PRAECIS study, which validated the efficacy of these blood-based biomarkers in the detection of the development of severe preeclampsia, was conducted across 18 U.S. hospitals and involved over 700 expectant mothers nationwide. Women exhibiting a positive result based on the risk ratio of both assays (sFlt-1/PlGF ratio ≥ 40) can benefit from enhanced surveillance and accelerated care ahead of the onset of severe symptoms.

The assays are designed to run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer which uses Nobel Prize-winning TRACE chemistry technology to deliver results in under 30 minutes. The FDA clearance and availability of these pioneering biomarker tests empower healthcare professionals to improve their management of the condition and enhance outcomes for mothers and their babies. Both patients and medical providers stand to gain from these improved diagnostic tools that can predict the onset of severe preeclampsia, particularly in cases at risk of severe, early-onset disease or for women with diagnostic uncertainty.

“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,” said Alan Sachs, chief medical officer at Thermo Fisher Scientific. “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 U.S.”

Related Links:
Thermo Fisher Scientific Inc

New
Platinum Member
Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test
Magnetic Bead Separation Modules
MAG and HEATMAG
Complement 3 (C3) Test
GPP-100 C3 Kit
New
Gold Member
All-in-one Molecular Diagnosis System
Panall 8000

Print article
77 ELEKTRONIKA

Channels

Molecular Diagnostics

view channel
Image: Protein ‘signatures’ obtained via a blood sample can be used to predict the onset of 67 diseases (Photo courtesy of Queen Mary University of London)

Protein Signatures in Blood Can Predict Risk of Developing More Than 60 Diseases

Measuring specific proteins to diagnose conditions like heart attacks, where troponin is tested, is a well-established clinical practice. Now, new research highlights the broader potential of protein measurements... Read more

Hematology

view channel
Image: The Truvian diagnostic platform combines clinical chemistry, immunoassay and hematology testing in a single run (Photo courtesy of Truvian Health)

Automated Benchtop System to Bring Blood Testing To Anyone, Anywhere

Almost all medical decisions are dependent upon laboratory test results, which are essential for disease prevention and the management of chronic illnesses. However, routine blood testing remains limited worldwide.... Read more

Microbiology

view channel
Image: The Simplexa C. auris direct kit is a real-time polymerase chain reaction assay run on the LIAISON MDX instrument (Photo courtesy of Diasorin)

Novel Molecular Test to Help Prevent and Control Multi Drug-Resistant Fungal Pathogen in Healthcare Settings

Candida auris (C. auris) is a rapidly emerging multi drug-resistant fungal pathogen that is commonly found in healthcare environments, where it presents a challenge due to its ability to asymptomatically... Read more

Pathology

view channel
Image: The tool can improve precision oncology by accurately predicting molecular subtypes and therapy responses (Photo courtesy of Shutterstock)

Computational Tool Integrates Transcriptomic Data for Improved Breast Cancer Diagnosis and Treatment

Breast cancer is the most commonly diagnosed cancer globally, presenting in various subtypes that require precise identification for effective, personalized treatment. Traditionally, cancer subtyping has... Read more

Industry

view channel
Image: Beckman Coulter will utilize the ALZpath pTau217 antibody to detect key biomarker for Alzheimer\'s disease on its DxI 9000 immunoassay analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter Licenses Alzpath's Proprietary P-tau 217 Antibody to Develop Alzheimer's Blood Test

Cognitive assessments have traditionally been the primary method for diagnosing Alzheimer’s disease, but this approach has its limitations as symptoms become apparent only after significant brain changes... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.