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
New
Gold Member
Pre- Eclampsia Control
Acusera Pre-Eclampsia Control
New
Gold Member
Fully-auto Specific Protein (Nephelometry) Analyzer
PA240
Prefilled Tubes
Prefilled 5.0ml Tubes
Latest Immunology News
- 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
- Lab-on-a-Chip Approach Advances Immune–Cancer Cell Interaction Analysis
Channels
Clinical Chemistry
view channel
Mathematical Biomarkers Use Routine Blood Tests to Guide Adaptive Prostate Cancer Therapy
Personalizing systemic therapy for prostate cancer remains challenging because tumors can evolve under treatment pressure, driving resistance and early relapse. Continuous high-dose regimens may initially... Read more
Blood Metabolite Patterns May Enable Early Detection of Blood-Brain Barrier Injury
Early injury to the blood-brain barrier (BBB) can precede many neurological disorders but remains difficult to detect noninvasively. Laboratory markers that identify barrier dysfunction before symptoms... Read more
Blood Biomarker Study Reveals Population-Specific Differences in Alzheimer’s Disease
Blood-based biomarkers are emerging as tools for detecting Alzheimer’s disease–related changes without relying on advanced brain imaging or cerebrospinal fluid (CSF) analysis. However, much of the foundational... Read more
Molecular Diagnostics
view channel
New Liquid Biopsy Workflow Maximizes Tumor Signals from Limited Blood Samples
Liquid biopsy seeks to detect tumor-derived signals from small blood samples, but circulating cell-free DNA is scarce and heterogeneous, limiting sensitivity. Combining complementary signals such as methylation,... Read more
Blood Test for Lung Cancer Screening Receives FDA Breakthrough Device Designation
Lung cancer remains the leading cause of cancer death in the United States, yet only about 18% of people eligible for screening undergo low-dose computed tomography, the current guideline-recommended method.... Read more
Hematology
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
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
Plasma Cell-Free DNA Test Enables Earlier Diagnosis of Invasive Fungal Infections
Invasive fungal infections disproportionately affect immunocompromised patients, while diagnostic delays can contribute to substantial morbidity and mortality. Existing methods often depend on invasive... Read more
Pathology
view channel
AI Uses H&E Slides to Predict Key Biomarkers Across 32 Cancers
Molecular profiling is essential for characterizing solid tumors, but many laboratories still rely on separate genetic assays to detect alterations such as TP53 mutations. These workflows can be resource-intensive... Read more
AI Tool Identifies Slide Artifacts to Speed Digital Pathology Diagnosis
Pathology laboratories face growing case volumes, staffing pressures, and increasing diagnostic complexity that can delay results. At the same time, whole-slide images may contain quality defects such... Read more
FDA-Cleared Digital Pathology Platform Expands Interoperability for Primary Diagnosis
Rising cancer incidence is colliding with a shrinking pathologist workforce, intensifying pressure on diagnostic turnaround times in clinical laboratories. Many labs are adopting digital pathology to manage... Read more
Technology
view channel
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
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 moreIndustry
view channel
Collaboration Supports Global ADC Development with AI-Powered Tissue Analysis
Selecting patients for antibody-drug conjugates (ADCs) increasingly requires broader tissue context, as target expression alone may not fully explain therapeutic response. Laboratories and translational... Read more
Standardized Staining Technology Advances Digital Pathology Workflows
Digital pathology is increasingly used to streamline cancer diagnostics, yet staining variability can hinder slide interpretation and limit the reliability of artificial intelligence tools.... Read more
Global Testing Service Advances Leukemia MRD Monitoring
KMT2A rearrangements drive aggressive subsets of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) and are associated with relapse and poor outcomes. As menin inhibitors enter clinical... Read more