Alzheimer's Disease Biomarker Assay Heading for IVD Status
|
By LabMedica International staff writers Posted on 24 Jul 2017 |
|
Image: A structural representation of the ApoE protein from human blood plasma (Photo courtesy of Wikimedia Commons).
A clinical diagnostic kit that measures the concentration of the Alzheimer's disease blood biomarker APOEepsilon4 was unveiled at the Alzheimer’s Association Conference held in London, United Kingdom, from July 16-20, 2017.
The risk of developing Alzheimer’s disease (AD) is increased by three to five-folds with the presence of one epsilon4 allele and between 15 and 20 times with two alleles.
The frequency of the epsilon4 allele is approximately 40% in patients with AD. Furthermore, APOEepsilon4 carriers progress faster to clinical AD than do APOEepsilon4 non-carriers. Therefore, the presence of one or two epsilon4 alleles of the APOE gene is considered to be highly informative in epidemiological research and is currently being used for patient stratification in the latest clinical trials to evaluate AD treatments.
The Biocross (Valladolid, Spain) ApoE4 Blood Marker Assay is an immunoturbidimetry-based test. Each assay kit consists of two reagents: R1 (which contains a highly specific anti-apoE4 antibody) and R2 (a solution containing latex (polystyrene beads). During the assay, the anti-apoE4 antibody induces the agglutination of latex beads in the presence of apoE4 in the sample. This agglutination is proportional to the concentration of the apoE4 and can be measured manually or automatically with a spectrophotometer.
The ApoE4 Blood Marker Assay can be used with manageable cost in any of the clinical biochemistry analyzers that are available in most hospitals or clinical centers. The risk indicator is determined by a cost-effective and accurate blood test that is scheduled to obtain the European IVD CE mark and will be submitted for [U.S.] Food and Drug Administration approval by the end of the year.
Matthew Mittino, CEO of Biocross, said, “Introducing our risk test ApoE4 Blood Marker Assay to experts, researchers, physicians, neurologists, and specialists in neurodegenerative diseases from more than 70 countries, will mark a before and an after within clinical practice. It is a risk indicator that is already a qualitative leap, a cost-effective alternative in front of the existing ones. Now, the next step is to carry out an important information work to show its advantages to all professionals of the industry and to make it useful for improving people life quality.”
Related Links:
Biocross
The risk of developing Alzheimer’s disease (AD) is increased by three to five-folds with the presence of one epsilon4 allele and between 15 and 20 times with two alleles.
The frequency of the epsilon4 allele is approximately 40% in patients with AD. Furthermore, APOEepsilon4 carriers progress faster to clinical AD than do APOEepsilon4 non-carriers. Therefore, the presence of one or two epsilon4 alleles of the APOE gene is considered to be highly informative in epidemiological research and is currently being used for patient stratification in the latest clinical trials to evaluate AD treatments.
The Biocross (Valladolid, Spain) ApoE4 Blood Marker Assay is an immunoturbidimetry-based test. Each assay kit consists of two reagents: R1 (which contains a highly specific anti-apoE4 antibody) and R2 (a solution containing latex (polystyrene beads). During the assay, the anti-apoE4 antibody induces the agglutination of latex beads in the presence of apoE4 in the sample. This agglutination is proportional to the concentration of the apoE4 and can be measured manually or automatically with a spectrophotometer.
The ApoE4 Blood Marker Assay can be used with manageable cost in any of the clinical biochemistry analyzers that are available in most hospitals or clinical centers. The risk indicator is determined by a cost-effective and accurate blood test that is scheduled to obtain the European IVD CE mark and will be submitted for [U.S.] Food and Drug Administration approval by the end of the year.
Matthew Mittino, CEO of Biocross, said, “Introducing our risk test ApoE4 Blood Marker Assay to experts, researchers, physicians, neurologists, and specialists in neurodegenerative diseases from more than 70 countries, will mark a before and an after within clinical practice. It is a risk indicator that is already a qualitative leap, a cost-effective alternative in front of the existing ones. Now, the next step is to carry out an important information work to show its advantages to all professionals of the industry and to make it useful for improving people life quality.”
Related Links:
Biocross
Gold Member
Quality Control Material
iPLEX Pro Exome QC Panel
New
Hematology Consumables
Bioblood Devices
New
Japanese Encephalitis Test
Japanese Encephalitis Virus Real Time PCR Kit
Latest Technology News
- Online Tool Supports Family Screening for Inherited Cancer Risk
- Portable Breath Sensor Detects Pneumonia Biomarkers in Minutes
- New Electronic Pipette Enhances Workflows with Touchscreen Control
- AI Model Outperforms Clinicians in Rare Disease Detection
- AI-Driven Diagnostic Demonstrates High Accuracy in Detecting Periprosthetic Joint Infection
- Blood Test “Clocks” Predict Start of Alzheimer’s Symptoms
- AI-Powered Biomarker Predicts Liver Cancer Risk
- Robotic Technology Unveiled for Automated Diagnostic Blood Draws
- ADLM Launches First-of-Its-Kind Data Science Program for Laboratory Medicine Professionals
Channels
Clinical Chemistry
view channel
New CLIA Status Brings Mass Spectrometry Steroid Testing to Routine Labs
Steroid hormone measurement is a core application of clinical mass spectrometry, which is widely regarded as a diagnostic gold standard. Access to these high-specificity methods has often been constrained... Read more
Study Shows Dual Biomarkers Improve Accuracy of Alzheimer’s Detection
Alzheimer’s disease develops slowly, and biological changes can appear in blood many years before symptoms. While plasma assays for phosphorylated tau offer earlier detection, discerning whether these... Read more
Hematology
view channel
Rapid Cartridge-Based Test Aims to Expand Access to Hemoglobin Disorder Diagnosis
Sickle cell disease and beta thalassemia are hemoglobin disorders that often require referral to specialized laboratories for definitive diagnosis, delaying results for patients and clinicians.... Read more
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
Immunology
view channel
Study Identifies Inflammatory Pathway Driving Immunotherapy Resistance in Bladder Cancer
Bladder cancer remains a prevalent malignancy with variable responses to immune checkpoint inhibitors. Clinicians often observe elevated C-reactive protein and interleukin-6 in affected patients, yet the... Read more
Microfluidic Chip Detects Cancer Recurrence from Immune Response Signals
Early identification of treatment response and relapse remains a major challenge in solid tumors, where minimal residual disease is difficult to detect with routine imaging and blood tests.... Read more
Microbiology
view channel
WHO Endorses Rapid Point-of-Care Testing to Improve TB Detection
Tuberculosis (TB) remains a leading infectious killer, with more than 3,300 deaths and 29,000 new illnesses every day. Diagnostic delays and dependence on centralized laboratory networks continue to impede... Read more
Breath Analysis Approach Offers Rapid Detection of Bacterial Infection
Accurate and rapid identification of bacterial infections remains challenging in acute care, where delays can hinder timely, targeted therapy. Infectious diseases are a major cause of mortality worldwide,... Read more
Study Highlights Accuracy Gaps in Consumer Gut Microbiome Kits
Direct-to-consumer gut microbiome kits promise personalized insights by profiling fecal bacteria and generating health readouts, but their analytical accuracy remains uncertain. A new study shows that... Read more
WHO Recommends Near POC Tests, Tongue Swabs and Sputum Pooling for TB Diagnosis
Tuberculosis (TB) remains one of the world’s leading infectious disease killers, yet millions of cases go undiagnosed or are detected too late. Barriers such as reliance on sputum samples, limited laboratory... Read morePathology
view channel
Biopsy-Based Gene Test Predicts Recurrence Risk in Lung Adenocarcinoma
Lung cancer is the leading cause of cancer death, killing more people in the United States than breast, prostate, and colon cancers combined. In lung adenocarcinoma (LUAD), tumors that invade nearby blood... Read more
AI-Powered Tool to Transform Dermatopathology Workflow
Skin cancer accounts for the largest number of cancer diagnoses in the United States, placing sustained pressure on pathology services. Diagnostic interpretation can be variable for challenging melanocytic... Read more
Technology
view channel
Online Tool Supports Family Screening for Inherited Cancer Risk
Genetic test results in oncology often have implications for relatives who may share inherited cancer risk. Many health systems lack structured processes to help patients alert family members, limiting... Read more
Portable Breath Sensor Detects Pneumonia Biomarkers in Minutes
Pneumonia is commonly confirmed with chest X-rays or laboratory assays that can take hours, delaying clinical decisions in acute and outpatient settings. Breath-based diagnostics promise faster answers... Read more
Industry
view channel
Integrated DNA Technologies Expands into Clinical Diagnostics
Integrated DNA Technologies (IDT; Coralville, Iowa, USA) has announced the launch of Archer FUSIONPlex-HT Dx and VARIANTPlex-HT Dx. This launch marks the company’s first in vitro diagnostic (IVD) offerings... Read more
