New Pregnancy Assay Receives CE Marking and FDA Clearance
|
By LabMedica International staff writers Posted on 20 Jan 2014 |
|
![Image: The new high standard \"Access Total βhCG (5th IS)\" assay for pregnancy determination from Beckman Coulter Diagnostics (Photo courtesy of Beckman Coulter).](https://globetechcdn.com/mobile_labmedica/images/stories/articles/article_images/2014-01-20/MMS-003.gif "Image: The new high standard \\"Access Total βhCG (5th IS)\\" assay for pregnancy determination from Beckman Coulter Diagnostics (Photo courtesy of Beckman Coulter).")
Image: The new high standard \"Access Total βhCG (5th IS)\" assay for pregnancy determination from Beckman Coulter Diagnostics (Photo courtesy of Beckman Coulter).
The approved new pregnancy determination assay features a broad dynamic range and is the first to standardize to the World Health Organization's latest international standard.
To help move reproductive health management forward, Beckman Coulter Diagnostics of Beckman Coulter (Brea, CA, USA) has received the CE marking and US Food and Drug Administration (FDA) 510(k) clearance for its new "Access Total βhCG (5th IS)" assay. It is the first βhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for glycoprotein chorionic gonadotropin. The βhCG assay is critical in routine and emergency diagnosis as it is frequently ordered on women of childbearing-age who require treatment, which could potentially be harmful to a fetus. The expanded utility of the assay has also been CE Mark approved for Down syndrome assessment during pregnancy.
“As the first manufacturer to standardize to the WHO 5th IS, the new βhCG assay is an example of Beckman Coulter’s continuing dedication to lead the way in this important diagnostic field,” said John Blackwood, senior vice president of Product Management for Beckman Coulter Diagnostics; “The new assay is just one example of the innovations that comprise Beckman Coulter’s reproductive health portfolio—the most comprehensive immunoassay reproductive panel available on the market.”
The assay features a broad dynamic range with automatic onboard dilution capability, reducing the need for manual sample dilutions. As a part of the standardization, reference ranges have been updated to include additional populations that include women over the age of 40, postmenopausal women, and men. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, Beckman Coulter has further improved the Total βhCG (5th IS) to make it more resilient to preanalytical factors.
"Access" reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.
Related Links:
Beckman Coulter
To help move reproductive health management forward, Beckman Coulter Diagnostics of Beckman Coulter (Brea, CA, USA) has received the CE marking and US Food and Drug Administration (FDA) 510(k) clearance for its new "Access Total βhCG (5th IS)" assay. It is the first βhCG assay standardized to the highly purified World Health Organization (WHO) 5th International Standard (IS) for glycoprotein chorionic gonadotropin. The βhCG assay is critical in routine and emergency diagnosis as it is frequently ordered on women of childbearing-age who require treatment, which could potentially be harmful to a fetus. The expanded utility of the assay has also been CE Mark approved for Down syndrome assessment during pregnancy.
“As the first manufacturer to standardize to the WHO 5th IS, the new βhCG assay is an example of Beckman Coulter’s continuing dedication to lead the way in this important diagnostic field,” said John Blackwood, senior vice president of Product Management for Beckman Coulter Diagnostics; “The new assay is just one example of the innovations that comprise Beckman Coulter’s reproductive health portfolio—the most comprehensive immunoassay reproductive panel available on the market.”
The assay features a broad dynamic range with automatic onboard dilution capability, reducing the need for manual sample dilutions. As a part of the standardization, reference ranges have been updated to include additional populations that include women over the age of 40, postmenopausal women, and men. Additionally, in response to changing laboratory environments and the challenges faced in collecting serum samples, Beckman Coulter has further improved the Total βhCG (5th IS) to make it more resilient to preanalytical factors.
"Access" reproductive solutions are part of a comprehensive assay menu featured on the Access and UniCel Immunoassay Systems.
Related Links:
Beckman Coulter
New
Gold Member
Pre- Eclampsia Control
Acusera Pre-Eclampsia Control
Automated Coagulation Analyzer
Hemolumi H6
Electrolyte Analyzer
CBS-4000 (CBS-400)
Latest Immunology News
- Antibody Profiling Identifies Preclinical Inflammatory Bowel Disease Years Before Diagnosis
- Ultrasensitive Blood Test Detects Sjögren’s Signature Years Before Diagnosis
- New Assays Expand Cytokine Testing for Transplant and Immunocompromised Patients
- Cell-Free Assay Detects Functional IgE for Food Allergy Diagnosis
- Diagnostic Models Detect Hidden Eye Abnormalities After Mild COVID-19
- Anti-Lipid Antibody Biomarkers May Identify Early Lyme Disease and Persistent Symptoms
- Immune Biomarkers Could Identify Risk of Chronic Critical Illness on ICU Admission
- Emergency Department Opt-Out Testing Program Identifies Undiagnosed HIV
- Airway Immune Signature May Predict Tuberculosis Progression Risk
- New Cellular Biomarkers Correlate with Disease Severity in Sjögren Disease
- Lung Immune Profiling Reveals Distinct Severe Pneumonia Subtypes
- Lab-on-a-Chip Approach Advances Immune–Cancer Cell Interaction Analysis
- Antibody Profiles Provide Clues to Long COVID Severity and Symptoms
- Aptamer-Based Biosensor Enables Mutation-Resilient SARS-CoV-2 Detection
- Metabolic Biomarker Distinguishes Latent from Active Tuberculosis and Tracks Treatment Response
- Study Points to Autoimmune Pathway Behind Long COVID Symptoms
Channels
Clinical Chemistry
view channel
Preoperative Blood Test Predicts Colorectal Cancer Recurrence and Metastasis
Cancer cells require large amounts of nutrients to grow and proliferate, and amino acids support key processes including protein formation, energy production, and DNA synthesis. Colorectal cancer is marked... Read more
New Machine-Learning Equation Improves LDL Cholesterol Assessment
Accurate assessment of low-density lipoprotein (LDL) cholesterol is central to cardiovascular risk management, yet calculation methods can underestimate values in some patients. Laboratories widely use... Read more
Molecular Diagnostics
view channel
Residual Disease Test Predicts Merkel Cell Carcinoma Recurrence Earlier Than Antibody Assay
Merkel cell carcinoma is a rare, aggressive skin cancer with a substantial risk of relapse, occurring in about 40% of patients. Surveillance remains challenging because widely used serologic monitoring... Read more
Portable Rapid Test Aims to Detect Ebola at Point of Care
Rapid confirmation of Ebola virus disease (EVD) is essential for isolation, contact tracing, and timely care, yet many outbreak zones lack access to advanced laboratories. The current emergency in the... Read more
Hematology
view channel
Spectral Flow Cytometry Assay Enhances MRD Detection in Multiple Myeloma
imal residual disease (MRD) monitoring is pivotal in multiple myeloma, where persistent malignant plasma cells drive relapse risk and help guide therapy decisions. In the United States, approximately 202,000... Read more
New Marker Helps Detect Aggressive Multiple Myeloma Earlier
Multiple myeloma is an incurable malignancy of plasma cells and the second most common blood cancer worldwide, with more than 188,000 new cases each year. Although therapies have advanced, most patients... Read more
Microbiology
view channel
New Rapid Ebola Antigen Test Detects Infection at Point of Care
A serious Ebola epidemic centered in the Democratic Republic of the Congo has caused hundreds of deaths and triggered a global public health emergency, with cases also reported in Uganda.... Read more
Syndromic GI Panel Detects Cyclospora for Rapid Case Confirmation
U.S. health authorities have reported a rapid increase in cyclosporiasis since May 2026, with more than 1,600 confirmed infections and thousands of additional suspected cases under investigation.... Read more
Rapid Panel Identifies Gram-Negative Pathogens and Resistance Markers in Bloodstream Infections
Bloodstream infections require rapid identification of causative pathogens and resistance mechanisms to guide effective therapy. Delays in profiling gram-negative organisms, which are frequently associated... Read more
Pathology
view channel
Digital Pathology Tool Predicts Breast Cancer Outcomes and Therapy Response
Breast cancer prognosis often depends on microscopic assessment of tumor architecture, a process that can be subjective and lead to variable predictions across patient groups. Quantitative measures that... Read more
AI Bone Marrow Mapping Provides New Tool to Track Blood Cancer Severity
Myelodysplastic neoplasms, a group of blood cancers that primarily affect older adults, are challenging to stage and monitor, often requiring repeated bone marrow biopsies that can yield uncertain interpretations.... Read more
Technology
view channel
Training Device Improves Accuracy of Pooled Molecular Diagnostics
High-throughput molecular diagnostics have transformed infectious disease detection, but many workflows remain difficult to execute accurately without extensive training. Sample pooling can cut per‑test... Read more
New CE-Certified Software Advances Whole-Genome Cancer Testing
European hospitals are increasingly using comprehensive tumor genomics to guide therapy, but routine whole genome sequencing (WGS) requires validated, regulation-compliant workflows. A newly CE-certified... Read more
National Rare Disease Registry Standardizes Genetic and Clinical Data for Coordinated Care
Rare diseases collectively impose a significant clinical burden despite their individual rarity, often involving multisystem presentations and prolonged diagnostic journeys. Limited specialist expertise... Read more
Industry
view channel
Collaboration Advances Extracellular Vesicle-Based Tests for Neurodegenerative Diseases
NanoSomiX, Inc. and Beckman Coulter Diagnostics announced a collaboration to explore the development of next-generation immunoassays for neurodegenerative diseases using extracellular vesicles (EVs).... Read more
