Automated Test for Galectin-3 Cleared for Chronic Heart Failure Prognosis
|
By LabMedica International staff writers Posted on 21 Jul 2015 |
|
Image: The ARCHITECT ci4100 clinical chemistry and immunoassay testing analyzer (Photo courtesy of Abbott Diagnostics).
Higher levels of galectin-3 are associated with a more aggressive form of heart failure, which may make identification of high-risk patients using galectin-3 testing an important part of patient care.
Galectin-3 is a protein that is involved in fundamental disease processes, including the development of fibrosis in organ tissues and cardiac remodeling, which may lead to the development and progression of heart failure.
An automated blood test was officially cleared by the United States Food and Drug Administration (FDA; Silver Springs, MD, USA) for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The test is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or plasma by enzyme linked immunosorbent assay (ELISA) on a microtiter plate platform.
The ARCHITECT Galectin-3 assay (Abbott Diagnostics; Abbot Park, IL, USA) is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and ethylenediaminetetraacetic acid (EDTA) plasma. The ARCHITECT Galectin-3 assay is performed using the Abbott ARCHITECT automated immunoassay analyzer and is being commercialized through an agreement between BG Medicine (Waltham, MA, USA) and Abbott. The ARCHITECT Galectin-3 assay is used with the ARCHITECT i System with STAT protocol capability.
Results should be interpreted along with clinical findings and other laboratory test results. Levels of galectin-3 in blood may be increased in patients with certain cancers and conditions associated with organ fibrosis. The ARCHITECT Galectin-3 assay is not indicated for detection, diagnosis, prognosis, or any uses associated with any type of cancer, conditions associated with organ fibrosis, or any other condition.
Paul R. Sohmer, MD, president and CEO of BG Medicine, Inc., said, “We believe that the introduction of automated galectin-3 testing will improve access to galectin-3 testing, shorten turn-around time for delivery of test results, and, as a result, accelerate adoption of galectin-3 testing in the United States.”
Related Links:
United States Food and Drug Administration
Abbott Diagnostics
BG Medicine
Galectin-3 is a protein that is involved in fundamental disease processes, including the development of fibrosis in organ tissues and cardiac remodeling, which may lead to the development and progression of heart failure.
An automated blood test was officially cleared by the United States Food and Drug Administration (FDA; Silver Springs, MD, USA) for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The test is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or plasma by enzyme linked immunosorbent assay (ELISA) on a microtiter plate platform.
The ARCHITECT Galectin-3 assay (Abbott Diagnostics; Abbot Park, IL, USA) is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and ethylenediaminetetraacetic acid (EDTA) plasma. The ARCHITECT Galectin-3 assay is performed using the Abbott ARCHITECT automated immunoassay analyzer and is being commercialized through an agreement between BG Medicine (Waltham, MA, USA) and Abbott. The ARCHITECT Galectin-3 assay is used with the ARCHITECT i System with STAT protocol capability.
Results should be interpreted along with clinical findings and other laboratory test results. Levels of galectin-3 in blood may be increased in patients with certain cancers and conditions associated with organ fibrosis. The ARCHITECT Galectin-3 assay is not indicated for detection, diagnosis, prognosis, or any uses associated with any type of cancer, conditions associated with organ fibrosis, or any other condition.
Paul R. Sohmer, MD, president and CEO of BG Medicine, Inc., said, “We believe that the introduction of automated galectin-3 testing will improve access to galectin-3 testing, shorten turn-around time for delivery of test results, and, as a result, accelerate adoption of galectin-3 testing in the United States.”
Related Links:
United States Food and Drug Administration
Abbott Diagnostics
BG Medicine
Gold Member
Collection and Transport System
PurSafe Plus®
Alcohol Testing Device
Dräger Alcotest 7000
New
Gold Member
Clinical Drug Testing Panel
DOA Urine MultiPlex
Latest Pathology News
- Engineered Yeast Cells Enable Rapid Testing of Cancer Immunotherapy
- First-Of-Its-Kind Test Identifies Autism Risk at Birth
- AI Algorithms Improve Genetic Mutation Detection in Cancer Diagnostics
- Skin Biopsy Offers New Diagnostic Method for Neurodegenerative Diseases
- Fast Label-Free Method Identifies Aggressive Cancer Cells
- New X-Ray Method Promises Advances in Histology
- Single-Cell Profiling Technique Could Guide Early Cancer Detection
- Intraoperative Tumor Histology to Improve Cancer Surgeries
- Rapid Stool Test Could Help Pinpoint IBD Diagnosis
- AI-Powered Label-Free Optical Imaging Accurately Identifies Thyroid Cancer During Surgery
- Deep Learning–Based Method Improves Cancer Diagnosis
- ADLM Updates Expert Guidance on Urine Drug Testing for Patients in Emergency Departments
- New Age-Based Blood Test Thresholds to Catch Ovarian Cancer Earlier
- Genetics and AI Improve Diagnosis of Aortic Stenosis
- AI Tool Simultaneously Identifies Genetic Mutations and Disease Type
- Rapid Low-Cost Tests Can Prevent Child Deaths from Contaminated Medicinal Syrups
Channels
Clinical Chemistry
view channel
New PSA-Based Prognostic Model Improves Prostate Cancer Risk Assessment
Prostate cancer is the second-leading cause of cancer death among American men, and about one in eight will be diagnosed in their lifetime. Screening relies on blood levels of prostate-specific antigen... Read more
Extracellular Vesicles Linked to Heart Failure Risk in CKD Patients
Chronic kidney disease (CKD) affects more than 1 in 7 Americans and is strongly associated with cardiovascular complications, which account for more than half of deaths among people with CKD.... Read more
Molecular Diagnostics
view channel
Diagnostic Device Predicts Treatment Response for Brain Tumors Via Blood Test
Glioblastoma is one of the deadliest forms of brain cancer, largely because doctors have no reliable way to determine whether treatments are working in real time. Assessing therapeutic response currently... Read more
Blood Test Detects Early-Stage Cancers by Measuring Epigenetic Instability
Early-stage cancers are notoriously difficult to detect because molecular changes are subtle and often missed by existing screening tools. Many liquid biopsies rely on measuring absolute DNA methylation... Read more
“Lab-On-A-Disc” Device Paves Way for More Automated Liquid Biopsies
Extracellular vesicles (EVs) are tiny particles released by cells into the bloodstream that carry molecular information about a cell’s condition, including whether it is cancerous. However, EVs are highly... Read more
Blood Test Identifies Inflammatory Breast Cancer Patients at Increased Risk of Brain Metastasis
Brain metastasis is a frequent and devastating complication in patients with inflammatory breast cancer, an aggressive subtype with limited treatment options. Despite its high incidence, the biological... Read moreHematology
view channel
New Guidelines Aim to Improve AL Amyloidosis Diagnosis
Light chain (AL) amyloidosis is a rare, life-threatening bone marrow disorder in which abnormal amyloid proteins accumulate in organs. Approximately 3,260 people in the United States are diagnosed... Read more
Fast and Easy Test Could Revolutionize Blood Transfusions
Blood transfusions are a cornerstone of modern medicine, yet red blood cells can deteriorate quietly while sitting in cold storage for weeks. Although blood units have a fixed expiration date, cells from... Read more
Automated Hemostasis System Helps Labs of All Sizes Optimize Workflow
High-volume hemostasis sections must sustain rapid turnaround while managing reruns and reflex testing. Manual tube handling and preanalytical checks can strain staff time and increase opportunities for error.... Read more
High-Sensitivity Blood Test Improves Assessment of Clotting Risk in Heart Disease Patients
Blood clotting is essential for preventing bleeding, but even small imbalances can lead to serious conditions such as thrombosis or dangerous hemorrhage. In cardiovascular disease, clinicians often struggle... Read moreMicrobiology
view channel
Comprehensive Review Identifies Gut Microbiome Signatures Associated With Alzheimer’s Disease
Alzheimer’s disease affects approximately 6.7 million people in the United States and nearly 50 million worldwide, yet early cognitive decline remains difficult to characterize. Increasing evidence suggests... Read more
AI-Powered Platform Enables Rapid Detection of Drug-Resistant C. Auris Pathogens
Infections caused by the pathogenic yeast Candida auris pose a significant threat to hospitalized patients, particularly those with weakened immune systems or those who have invasive medical devices.... Read more
Pathology
view channel
Engineered Yeast Cells Enable Rapid Testing of Cancer Immunotherapy
Developing new cancer immunotherapies is a slow, costly, and high-risk process, particularly for CAR T cell treatments that must precisely recognize cancer-specific antigens. Small differences in tumor... Read more
First-Of-Its-Kind Test Identifies Autism Risk at Birth
Autism spectrum disorder is treatable, and extensive research shows that early intervention can significantly improve cognitive, social, and behavioral outcomes. Yet in the United States, the average age... Read more
Technology
view channel
Robotic Technology Unveiled for Automated Diagnostic Blood Draws
Routine diagnostic blood collection is a high‑volume task that can strain staffing and introduce human‑dependent variability, with downstream implications for sample quality and patient experience.... Read more
ADLM Launches First-of-Its-Kind Data Science Program for Laboratory Medicine Professionals
Clinical laboratories generate billions of test results each year, creating a treasure trove of data with the potential to support more personalized testing, improve operational efficiency, and enhance patient care.... Read more
Aptamer Biosensor Technology to Transform Virus Detection
Rapid and reliable virus detection is essential for controlling outbreaks, from seasonal influenza to global pandemics such as COVID-19. Conventional diagnostic methods, including cell culture, antigen... Read more
AI Models Could Predict Pre-Eclampsia and Anemia Earlier Using Routine Blood Tests
Pre-eclampsia and anemia are major contributors to maternal and child mortality worldwide, together accounting for more than half a million deaths each year and leaving millions with long-term health complications.... Read moreIndustry
view channel
New Collaboration Brings Automated Mass Spectrometry to Routine Laboratory Testing
Mass spectrometry is a powerful analytical technique that identifies and quantifies molecules based on their mass and electrical charge. Its high selectivity, sensitivity, and accuracy make it indispensable... Read more
AI-Powered Cervical Cancer Test Set for Major Rollout in Latin America
Noul Co., a Korean company specializing in AI-based blood and cancer diagnostics, announced it will supply its intelligence (AI)-based miLab CER cervical cancer diagnostic solution to Mexico under a multi‑year... Read more
Diasorin and Fisher Scientific Enter into US Distribution Agreement for Molecular POC Platform
Diasorin (Saluggia, Italy) has entered into an exclusive distribution agreement with Fisher Scientific, part of Thermo Fisher Scientific (Waltham, MA, USA), for the LIAISON NES molecular point-of-care... Read more