New Diagnostic Monitors Patients for Epithelial Ovarian Cancer
|
By LabMedica International staff writers Posted on 16 Feb 2010 |
|
A new diagnostic tool can be used to monitor patients for epithelial ovarian cancer, the most common form of ovarian cancer.
The Architect human epididymis protein 4 (HE4) assay uses a simple blood test to help monitor for the recurrence or progression of epithelial ovarian cancer. HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any marker and is considered the best single marker for stage 1 of the disease.
Abbott (Abbott Park, IL, USA) partnered with Fujirebio Diagnostics, Inc. (Malvern, PA, USA) in the development of the immunoassay. The Architect HE4 assay is approved for use in Europe, as well as in other countries in Asia Pacific and Latin America. It is currently an investigational device in the United States. Abbott has submitted the new automated ovarian cancer test for 510(k) clearance by the US Food and Drug Administration (FDA; Silver Spring, MD, USA).
According to the American Cancer Society, the five-year survival rate of ovarian cancer patients is 46 %. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93 %. Less than 20 % of all ovarian cancer is found in the early stage.
The Architect HE4 assay must be used in conjunction with other clinical data. It should not be used as a cancer-screening test. In addition, certain types of cancer (e.g., mucinous or germ cell tumors) rarely express HE4, and the use of the Architect HE4 assay is not recommended for monitoring patients with those types of cancer.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture, and marketing of medical products, including nutritionals, devices, diagnostics, and of pharmaceuticals.
Related Links:
Abbott
Fujirebio Diagnostics, Inc.
US Food and Drug Administration
American Cancer Society
.jpg)
The Architect human epididymis protein 4 (HE4) assay uses a simple blood test to help monitor for the recurrence or progression of epithelial ovarian cancer. HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any marker and is considered the best single marker for stage 1 of the disease.
Abbott (Abbott Park, IL, USA) partnered with Fujirebio Diagnostics, Inc. (Malvern, PA, USA) in the development of the immunoassay. The Architect HE4 assay is approved for use in Europe, as well as in other countries in Asia Pacific and Latin America. It is currently an investigational device in the United States. Abbott has submitted the new automated ovarian cancer test for 510(k) clearance by the US Food and Drug Administration (FDA; Silver Spring, MD, USA).
According to the American Cancer Society, the five-year survival rate of ovarian cancer patients is 46 %. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93 %. Less than 20 % of all ovarian cancer is found in the early stage.
The Architect HE4 assay must be used in conjunction with other clinical data. It should not be used as a cancer-screening test. In addition, certain types of cancer (e.g., mucinous or germ cell tumors) rarely express HE4, and the use of the Architect HE4 assay is not recommended for monitoring patients with those types of cancer.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture, and marketing of medical products, including nutritionals, devices, diagnostics, and of pharmaceuticals.
Related Links:
Abbott
Fujirebio Diagnostics, Inc.
US Food and Drug Administration
American Cancer Society
Gold Member
Clinical Chemistry Assay
Sorbitol Dehydrogenase (SDH)
Pipette Calibration System
Artel PCS®
New
Automated Coagulation Analyzer
Hemolumi H6
Latest Immunology News
- 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
- T-Cell Senescence Profiling May Predict CAR T Responses
- Finger-Prick Lateral Flow Test Detects Sepsis Biomarkers at Point of Care
- Study Highlights Low Sensitivity of Current Lyme Tests in Early Infection
- 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
Channels
Clinical Chemistry
view channel
Saliva-Based Test Detects Biochemical Signs of Sleep Loss
Acute sleep loss impairs cognition and motor skills, raising safety risks that resemble alcohol intoxication. Clinicians currently lack an objective biochemical test to determine when someone is dangerously... Read more
Simple Dual-Tau Blood Test Detects and Stages Alzheimer’s Disease
Alzheimer’s disease is typically confirmed and staged with positron emission tomography scans and cerebrospinal fluid testing, procedures that are costly and invasive. Broader access to minimally invasive... Read more
Alzheimer’s Blood Biomarkers Linked to Early Cognitive Differences Before Dementia
Blood-based screening for Alzheimer’s disease offers a noninvasive, lower-cost alternative to brain imaging or spinal fluid testing, yet its ability to flag the earliest cognitive changes has been unclear.... Read more
Molecular Diagnostics
view channel
New PCR Assay Supports Bundibugyo Ebola Outbreak Surveillance
Rapid identification of Ebola infections is essential to limit transmission and guide public health response, yet detection can be difficult when outbreaks involve rare variants. The current outbreaks... Read more
Plasma Protein Signature Predicts Lung Cancer Risk Up to Five Years Ahead
Lung cancer remains a leading cause of cancer death, and many cases are detected only after symptoms appear. Current screening programs largely target people with a history of smoking, leaving other at-risk... 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
New Culture Medium Speeds C. difficile Resistance Detection and Reduces Costs
Clostridioides difficile infections remain a persistent threat in hospitals and communities, affecting about 500,000 people in the United States each year. Severe cases can be fatal within 30 days of diagnosis,... Read more
Automated Blood Culture System Speeds Detection of Bloodstream Infections
Bloodstream infections and sepsis require rapid laboratory detection to guide targeted antimicrobial therapy and reduce mortality. Conventional blood culture workflows can delay actionable results by critical... Read more
Pathology
view channel
3D Spatial Multi-Omics Maps Intra-Tumor Diversity in Colorectal Cancer
Colorectal cancer remains a leading cause of cancer death, and clinical decision-making is complicated by marked intra-tumor heterogeneity. Conventional bulk sequencing averages molecular signals across... Read more
Blood-Based Method Tracks Gene Activity in the Living Brain
Real-time measurement of gene activity in the brain has been limited by assays requiring destructive tissue sampling. Tracking active genes could reveal how the body responds to environmental factors,... 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
Collaboration Advances ctDNA-Guided Development in Metastatic Colorectal Cancer
Natera, Inc. (Austin, TX, USA) and CytoDyn Inc. (Vancouver, WA, USA) announced a strategic collaboration focused on metastatic colorectal cancer (mCRC). Under the agreement, Natera will evaluate circulating... Read more
