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
Nucleic Acid Extractor System
NEOS-96 XT
HPV Test
Allplex HPV28 Detection
Creatinine/eGFR Meter
StatSensor® Creatinine/eGFR Meter
Latest Immunology News
- 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
- Immune Enzyme Linked to Treatment-Resistant Inflammatory Bowel Disease
- Simple Blood Test Could Replace Biopsies for Lung Transplant Rejection Monitoring
- Routine TB Screening Test May Reveal Immune Aging and Mortality Risk
- Biomarkers and Molecular Testing Advance Precision Allergy Care
- Point-of-Care Tests Could Expand Access to Mpox Diagnosis
Channels
Clinical Chemistry
view channel
FDA-Approved Test Identifies Low Risk of Large Esophageal Varices in Cirrhosis
Chronic liver disease contributes substantially to mortality, and clinicians routinely screen adults with compensated cirrhosis for varices to prevent bleeding. However, endoscopy is invasive and reso... Read more
Blood Protein Signature Diagnoses Pediatric IBD and Distinguishes Subtypes
Confirming pediatric inflammatory bowel disease (IBD) often requires imaging, endoscopy, and histopathology, prolonging time to diagnosis. Reliable, noninvasive blood tests remain an unmet need in routine... Read more
Molecular Diagnostics
view channel
Blood-Based RNA Biomarker Improves Prediction of Alzheimer’s Onset
Timely identification of patients approaching symptomatic Alzheimer’s disease (AD) remains a major clinical challenge, even as blood-based biomarkers continue to advance. Current assays are highly effective... Read more
Multiplex PCR Test Identifies Seven STI Pathogens in One Hour
Sexually transmitted infections (STIs) continue to rise, increasing demand for rapid, accurate detection of multiple pathogens across varied sample types. To support flexible, standardized testing, a new... Read more
Hematology
view channel
Next-Generation Hematology Platform Streamlines High-Complexity Lab Workflows
Sysmex America (Chicago, IL, USA) has introduced the next generation XR-Series, centered on the XR-10 Automated Hematology Module for high-complexity laboratories. The platform builds on the widely used... Read more
Blood Eosinophil Count May Predict Cancer Immunotherapy Response and Toxicity
Immune checkpoint inhibitors have improved outcomes across many cancers, yet only a subset of patients derive durable benefit and biomarkers to guide treatment remain limited. Eosinophils, best known for... Read more
Microbiology
view channel
H. pylori Screening Within Colorectal Program Aids Gastric Cancer Prevention
Health systems increasingly rely on economic evidence to guide cancer prevention strategies. For gastric cancer, selecting screening approaches that can integrate with existing programs is a key policy question.... Read more
Machine Learning Reveals Consistent Gut Microbiome Patterns in Colorectal Cancer
Colorectal cancer has been repeatedly linked to alterations in the gut microbiome, yet findings have often varied across small, heterogeneous studies. Reproducibility has been limited by differing sequencing... Read more
Pathology
view channel
AI Pathology Tool Predicts Immunotherapy Response in Rare Cancers
Immunotherapy has transformed care for select malignancies, yet predicting which patients with rare cancers are most likely to benefit remains challenging. Clinicians often have only limited biomarkers... Read more
Uncertainty-Aware AI Tool Improves Digital Pathology for Cancer Subtyping
Reliable histologic subtyping guides therapy selection in oncology, yet diagnostic workflows grow more complex as whole-slide imaging and artificial intelligence (AI) expand. A persistent obstacle to clinical... Read more
Technology
view channel
AI Platform Links Biomarker Results to Cancer Clinical Trials and Guidelines
Oncology teams must manage growing volumes of genomic data, rapidly evolving clinical trial options, and frequently updated care guidelines, all within tight clinic schedules. Translating complex tumor... Read more
Agentic AI Platform Supports Genomic Decision-Making in Oncology
Oncology care teams increasingly face the challenge of managing complex molecular diagnostics, evolving treatment options, and extensive electronic health record documentation. Translating multimodal data... Read more
Industry
view channel
Partnership Integrates Automated DNA Extraction with Single-Molecule Digital PCR
Countable Labs (Palo Alto, CA, USA) and Promega (Madison, WI, USA) have entered a co-marketing agreement that integrates the Promega Maxwell System for nucleic acid extraction with Countable Labs’ Countable... Read more
