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
Gold Member
Quality Control Material
iPLEX Pro Exome QC Panel
Gold Member
Flocked Fiber Swabs
Puritan® Patented HydraFlock®
New
Chromogenic Culture System
InTray™ COLOREX™ ECC
New
Clinical Informatics Platform
CLARION™
Latest Immunology News
- Immune Aging Clock Quantifies Immunosenescence and Identifies Therapeutic Target
- Study Finds Influenza Often Undiagnosed in Winter Deaths
- Combined Screening Approach Identifies Early Leprosy Cases
- Antibody Blood Test Identifies Active TB and Distinguishes Latent Infection
- FDA Approval Expands Use of PD-L1 Companion Diagnostic in Esophageal and GEJ Carcinomas
- Study Identifies Inflammatory Pathway Driving Immunotherapy Resistance in Bladder Cancer
- Microfluidic Chip Detects Cancer Recurrence from Immune Response Signals
- Cancer Mutation ‘Fingerprints’ to Improve Prediction of Immunotherapy Response
- Immune Signature Identified in Treatment-Resistant Myasthenia Gravis
- New Biomarker Predicts Chemotherapy Response in Triple-Negative Breast Cancer
- Blood Test Identifies Lung Cancer Patients Who Can Benefit from Immunotherapy Drug
- Whole-Genome Sequencing Approach Identifies Cancer Patients Benefitting From PARP-Inhibitor Treatment
- Ultrasensitive Liquid Biopsy Demonstrates Efficacy in Predicting Immunotherapy Response
- Blood Test Could Identify Colon Cancer Patients to Benefit from NSAIDs
- Blood Test Could Detect Adverse Immunotherapy Effects
- Routine Blood Test Can Predict Who Benefits Most from CAR T-Cell Therapy
Channels
Clinical Chemistry
view channel
Routine Blood Count Ratio Linked to Future Alzheimer’s and Dementia Risk
Alzheimer’s disease and related dementias develop over years, making it difficult to identify at-risk patients before symptoms appear. Clinicians therefore need widely available laboratory markers that... Read more
Label-Free Microfluidic Device Enriches Tumor Cells and Clusters from Pleural Effusions
Diagnosing malignancy from pleural effusion remains challenging because tumor cells are rare and clusters are easily disrupted during processing. Conventional cytology can miss malignant tumor cells and... Read more
Rapid Biosensor Detects Pancreatic Cancer Biomarker for Early Detection
Pancreatic cancer is frequently identified only after it has progressed because early disease is typically asymptomatic, and survival remains extremely poor once advanced. Conventional laboratory assays... Read more
Urine-Based Multi-Cancer Screening Test Receives FDA Breakthrough Device Designation
Early detection across multiple cancers remains a major unmet need in population screening. Non-invasive approaches that can be delivered at scale may broaden access and shift diagnoses to earlier stages.... Read moreMolecular Diagnostics
view channel
AI Blood Test Enhances Monitoring of Liver Cirrhosis Progression
Monitoring chronic liver disease remains difficult because clinicians rely on tools that can be inconsistent and may miss early progression. Standard approaches often combine ultrasound imaging with blood-based... Read more
Cancer-Related Mutations in Immune Cells Linked to Alzheimer’s
Alzheimer’s disease is marked by protein aggregation and inflammatory changes in the brain’s immune system, yet its molecular drivers remain incompletely understood. With aging, human cells accumulate... Read more
Composite Blood Biomarkers Enable Early Detection of Common Cancers
Early diagnosis of colorectal, lung, and ovarian cancers remains challenging, with many patients identified only after tumors have begun to spread. A scalable blood test could expand access to screening,... Read more
Machine Learning Model Uses DNA Methylation to Predict Tumor Origin in Cancers of Unknown Primary
Cancers of unknown primary (CUP) are metastatic malignancies in which the primary site cannot be identified, complicating treatment selection. Many patients consequently receive broad, nonspecific chemotherapy... Read moreHematology
view channel
Single Assay Enables Rapid HLA and ABO Genotyping for Transplant Matching
CareDx (Brisbane, CA, USA) has introduced AlloSeq Nano, a nanopore‑based HLA (human leukocyte antigen) and ABO genotyping solution unveiled at the European Federation for Immunogenetics (EFI) Conference 2026.... Read more
Prognostic Biomarker Identified in Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma and often presents with aggressive clinical behavior. Although many patients respond to standard chemotherapy with... Read more
Microbiology
view channel
Oral–Gut Microbiome Signatures Identify Early Gastric Cancer
Early detection of gastric cancer could be advanced by scalable screening strategies using minimally invasive sampling. Saliva collection is noninvasive and cost-effective, supporting wider adoption... Read more
Label-Free Microscopy Methodd Enables Faster, Quantitative Detection of Malaria
Microscopy of blood smears remains a cornerstone for malaria diagnosis but can be slow, stain-dependent, and operator intensive. With more than 200 million infections and over 600,000 deaths annually,... Read more
Gut Microbiome Test Predicts Melanoma Recurrence After Surgery
Melanoma remains prone to relapse even after surgery and adjuvant immunotherapy, with 25% to 40% of patients experiencing recurrence. Clinicians lack reliable pre-treatment indicators to identify those... Read more
Rapid Blood-Culture Susceptibility Panel Expands Coverage for Gram-Negative Infections
Gram-negative bloodstream infections and sepsis demand fast, precise antimicrobial therapy, yet conventional susceptibility workflows can delay targeted treatment. Clinical laboratories need platforms... Read morePathology
view channel
Interpretable AI Reveals Hidden Cellular Features from Microscopy Images
Microscopy images contain rich clues about cell health, but many disease-relevant morphological differences are too subtle to see and difficult to quantify consistently. Artificial intelligence (AI) has... Read more
Tumor Immune Structure Predicts Response to Immunotherapy in Melanoma
Many patients with advanced melanoma start on anti-PD-1 immunotherapy, but responses can wane or never develop. Clinicians often turn to anti-CTLA-4 after resistance emerges, yet predicting who will respond... Read more
Technology
view channel
AI Tool Predicts Non-Response to Targeted Therapy in Colorectal Cancer
Advanced bowel cancer remains difficult to treat, and many patients receive targeted therapies that do not help them but still cause harm. Clinicians need reliable ways to identify likely responders before... Read more
Integrated System Streamlines Pre-Analytical Workflow for Molecular Testing
Pre-analytical variation remains a leading source of inconsistent molecular test results and added costs, particularly when laboratories rely on multiple instruments and protocols. Standardizing nucleic... Read more
Industry
view channel
QuidelOrtho Adds Ultra-Fast PCR Platform with LEX Acquisition
QuidelOrtho Corporation has completed the acquisition of LEX Diagnostics for approximately USD 100 million in cash. The transaction adds the LEX VELO System to QuidelOrtho’s portfolio. The platform received U.... Read more
Seegene Showcases Real-Time PCR Data Analytics Platform at ESCMID
Seegene introduced STAgora, a real-time data analytics platform built on aggregated statistical testing data, at ESCMID Global 2026 in Munich, where it also presented an enhanced model of its automated... Read more
Roche Affiliate Expands MRD Portfolio with SAGA Acquisition
Foundation Medicine, Inc., an independent affiliate of Roche, announced plans to expand its monitoring portfolio with SAGA Diagnostics’ Pathlight, a personalized, tumor-informed molecular residual disease... Read more