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
Platinum Member
Automated Coagulation Analyzer
Hemolumi H6
Gold Member
Pre- Eclampsia Control
Acusera Pre-Eclampsia Control
Pipette Calibration System
Artel PCS®
Chromogenic Culture System
InTray™ COLOREX™ ECC
Latest Immunology News
- AI-Based Antibody Profiling Predicts Strength of COVID-19 Vaccine Response
- Immune Biomarkers May Predict Recurrent Checkpoint Inhibitor Arthritis
- Immune Cell Blood Test May Predict Melanoma Immunotherapy Response
- Study Reveals Viral Protein Driving COVID-19-Related Vascular Injury
- Antibody Profiling Identifies Preclinical Inflammatory Bowel Disease Years Before Diagnosis
- Study Reveals Immune Mechanism Driving Severe COVID-19 Progression
- 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
Channels
Clinical Chemistry
view channel
Blood Test Markers Could Help Identify Older Adults at Risk of Disability
Maintaining independence into very old age is a growing public health challenge as Japan’s population rapidly ages. Nearly 60% of Japanese adults aged 85 years and older already receive support through... Read more
FDA Clears Roche Blood Test for Alzheimer’s Amyloid Pathology Assessment
An estimated 75% of people living with dementia remain undiagnosed, while confirmatory tools such as positron emission tomography (PET) or cerebrospinal fluid (CSF) testing can be costly, invasive, and... Read more
Rapid Ferritin Test Enables Iron Deficiency Detection at the Point of Care
Iron deficiency is one of the world’s most common nutritional disorders and can be difficult to diagnose where access to laboratories and trained personnel is limited. Women and children in low-resource... Read more
Alzheimer’s Blood Test Becomes First FDA-Cleared Option for Adults as Young as 40
C2N Diagnostics’ PrecivityAD2 blood test was cleared by the U.S. Food and Drug Administration (FDA) on August 20, 2026, for adults as young as 40 who are experiencing signs of cognitive impairment, according... Read moreMolecular Diagnostics
view channel
Genetic Risk Score Identifies Type 1 Diabetes in MODY Testing
Accurately distinguishing maturity-onset diabetes of the young from type 1 diabetes is difficult in routine care, especially when onset occurs in adolescence or early adulthood. Although maturity-onset... Read more
Self-Collected HPV Testing Reaches Patients Missed by Routine Screening
Timely cervical cancer screening prevents progression from persistent high‑risk human papillomavirus (HPV) infection, yet many adults marginalized from care do not complete routine exams.... Read more
Comprehensive Genomic Testing Expands Treatment Options for Advanced Cancers
Selecting effective therapies for advanced cancers remains difficult because standard tumor testing often targets only a limited set of genes. As options dwindle, many patients face decisions without strong... Read more
Multi-Omics Analysis Identifies Additional Risk Genes in Hereditary Breast and Ovarian Cancer
Hereditary breast and ovarian cancer can be difficult to explain genetically, leaving many high-risk families without clear answers. Although 13 established risk genes, including BRCA1 and BRCA2, are routinely... Read moreHematology
view channel
New Genetic Findings Reveal Cause of Bone Marrow Failure Syndrome
Inherited bone marrow failure syndromes (IBMFS) impair the bone marrow’s ability to produce sufficient healthy blood cells and are associated with an increased risk of early-onset myelodysplastic syndromes (MDS).... Read more
Ultra-Portable Device Enables Finger-Prick Blood Testing at Home
Patients who need frequent blood tests often face repeated clinic visits that burden services and disrupt care. In the UK, millions of tests are performed each year to diagnose disease, guide therapy,... Read more
Microbiology
view channel
Genetic Marker Identifies Emerging Resistance to Frontline Malaria Drugs
Artemisinin-based combination therapy remains central to controlling Plasmodium falciparum malaria, but emerging drug resistance is complicating treatment and surveillance. In Uganda and across sub-Saharan... Read more
Surveillance and Susceptibility Testing Track Rising Candida Auris in U.S.
Drug-resistant fungal infections are straining infection control and treatment in hospitals and long-term care facilities, where rapid transmission can lead to severe outcomes. Candida auris has expanded... Read more
Pathology
view channel
AI-Pathologist Framework Improves Accuracy and Reliability in Cancer Diagnosis
Ensuring reliable cancer diagnosis from digital pathology remains a critical challenge as clinical decisions rely on accurate slide interpretation. While artificial intelligence (AI) has accelerated whole-slide... Read more
New Review Highlights Intelligent Agents as Next Step for Digital Pathology
Digital pathology remains constrained by models that classify single images without mirroring how clinicians interrogate multiple slides, adjust magnification, and synthesize ancillary tests.... Read more
Simple Immunohistochemical Size Ratio Improves Classification of Primary Aldosteronism
Primary aldosteronism is a common but underdiagnosed cause of hypertension, in which excess aldosterone promotes salt retention and raises blood pressure. Identifying the dominant source of hormone overproduction... Read more
Technology
view channel
Autonomous Robotic System Receives FDA Authorization for Blood Collection
Venipuncture is central to many diagnostic pathways, but routine blood collection can be affected by staffing constraints and procedural variability that influence consistency and patient experience.... Read more
Interoperable Data Platform Standardizes Multi-Cancer Blood Test Results
Proteotype Diagnostics has introduced Alchemi, a proprietary data and clinical workflow platform being developed for Enlighten, the company’s investigational blood-based multi-cancer test.... Read more
Industry
view channel
New Collaboration Advances Precision Oncology Screening for Lung Cancer in Japan
Molecular profiling is central to precision oncology in lung cancer, but tissue samples can be limited and minimally invasive approaches are often preferable. Liquid biopsy enables blood-based genomic... Read more
