FDA-Cleared Automated Cell Counter for CSF Launched at AACC 2016
|
By LabMedica International staff writers Posted on 04 Aug 2016 |
|
Image: The GloCyte system delivers highly accurate and precise total nucleated cell and red blood cell counts using a novel combination of technologies (Photo courtesy of Advanced Instruments).
The system provides superior accuracy of low cell counts in cerebrospinal fluid samples. It is being introduced at the AACC Annual Scientific Meeting & Clinical Lab Expo (July 31 - August 4; Philadelphia, PA, USA). Linda Sandhaus, MD, University Hospitals Case Medical Center, presented a poster (#A-290) on August 2 titled GloCyte: A New Automated Technology for Cerebrospinal Fluid (CSF) Cell Counts.
Advanced Instruments, Inc. (Norwood, MA, USA) has received 510(k) clearance from the US Food & Drug Administration (FDA) to market its GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls. The patented GloCyte System is intended to provide a quantitative determination of red blood cells (RBCs) and total nucleated cells (TNCs) in CSF collected from adult and pediatric patients. Currently, low cell counts often present a challenge to standard methods.
“To date, there has not been a way to provide dependable, low cell counts,” said John Coughlin, president and CEO, Advanced Instruments, “We use a novel combination of fluorescence, microscopy with digital image analysis principles, highly specific reagents, and an intelligent counting algorithm to provide accurate and precise cell counts. We are very excited as this marks a major achievement in giving laboratories a new way to obtain reliable and timely CSF results.”
Additional benefits of the GloCyte System are that the test requires only 30 microliters of sample per test, it uses disposable test cartridges ensuring no sample carryover and easy disposal, and it includes built-in quality control of Levey-Jennings charts and an audit table. The company expects to begin GloCyte shipments in September 2016.
Related Links:
Advanced Instruments
Advanced Instruments, Inc. (Norwood, MA, USA) has received 510(k) clearance from the US Food & Drug Administration (FDA) to market its GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls. The patented GloCyte System is intended to provide a quantitative determination of red blood cells (RBCs) and total nucleated cells (TNCs) in CSF collected from adult and pediatric patients. Currently, low cell counts often present a challenge to standard methods.
“To date, there has not been a way to provide dependable, low cell counts,” said John Coughlin, president and CEO, Advanced Instruments, “We use a novel combination of fluorescence, microscopy with digital image analysis principles, highly specific reagents, and an intelligent counting algorithm to provide accurate and precise cell counts. We are very excited as this marks a major achievement in giving laboratories a new way to obtain reliable and timely CSF results.”
Additional benefits of the GloCyte System are that the test requires only 30 microliters of sample per test, it uses disposable test cartridges ensuring no sample carryover and easy disposal, and it includes built-in quality control of Levey-Jennings charts and an audit table. The company expects to begin GloCyte shipments in September 2016.
Related Links:
Advanced Instruments
Platinum Member
Automated Coagulation Analyzer
Hemolumi H6
Gold Member
Automatic Hematology Analyzer
CF9600
Manual Pipetting Aid
Pipette Controllers macro
Creatinine/eGFR Meter
StatSensor® Creatinine/eGFR Meter
Latest AACC 2016 News
- Molecular Test Detects Three Arboviruses in Plasma Samples
- Derived Exosomal Protein Biomarkers in Alzheimer’s Disease Diagnosis
- New Biochip Array Developed for ApoE4 Classification
- Cell-Free DNA Identifies Liver Transplant Patients with Acute Rejection
- New Method Tested for Early Diagnosis Pediatric Diabetic Nephropathy
- Semen Analysis Portfolio with Two New Products Featured at AACC 2016
- Automation Solutions for Clinical Diagnostic Equipment Showcased at AACC 2016
- New Tubes Designed for Medium Sample Volumes
- Multi Sample Osmometer Improves Testing Efficiency
- Innovative Information System Optimizes Laboratory Processes
- Innovative eLearning Interface Seamlessly Connects Competency Data
- Cloud-Based Connectivity Platform Advances Decentralized Healthcare
- Adhesives Research to Present Hydrophilic Adhesive Technologies
- Point-of-Care Immunoassay Analyzer on Display at AACC Annual Meeting
- Assay for Determination of 17-OH Progesterone to Be Featured at AACC Annual Meeting
- Fully Automated HbA1c Analyzer Available for Inspection at AACC Annual Meeting
Channels
Clinical Chemistry
view channel
Rapid Ferritin Test Enables Iron Deficiency Detection at the Point of Care
Iron deficiency is one of the world’s most common nutritional disorders and can be difficult to diagnose where access to laboratories and trained personnel is limited. Women and children in low-resource... Read more
Alzheimer’s Blood Test Becomes First FDA-Cleared Option for Adults as Young as 40
C2N Diagnostics’ PrecivityAD2 blood test was cleared by the U.S. Food and Drug Administration (FDA) on August 20, 2026, for adults as young as 40 who are experiencing signs of cognitive impairment, according... Read more
Molecular Diagnostics
view channel
Genetic Risk Score Identifies Type 1 Diabetes in MODY Testing
Accurately distinguishing maturity-onset diabetes of the young from type 1 diabetes is difficult in routine care, especially when onset occurs in adolescence or early adulthood. Although maturity-onset... Read more
Self-Collected HPV Testing Reaches Patients Missed by Routine Screening
Timely cervical cancer screening prevents progression from persistent high‑risk human papillomavirus (HPV) infection, yet many adults marginalized from care do not complete routine exams.... Read more
Comprehensive Genomic Testing Expands Treatment Options for Advanced Cancers
Selecting effective therapies for advanced cancers remains difficult because standard tumor testing often targets only a limited set of genes. As options dwindle, many patients face decisions without strong... Read more
Multi-Omics Analysis Identifies Additional Risk Genes in Hereditary Breast and Ovarian Cancer
Hereditary breast and ovarian cancer can be difficult to explain genetically, leaving many high-risk families without clear answers. Although 13 established risk genes, including BRCA1 and BRCA2, are routinely... Read moreHematology
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
Immunology
view channel
AI-Based Antibody Profiling Predicts Strength of COVID-19 Vaccine Response
Vaccine-induced protection can vary widely between individuals, creating uncertainty for clinicians, particularly in patients with immunosuppressive conditions. Demographic and health factors explain only... Read more
Immune Biomarkers May Predict Recurrent Checkpoint Inhibitor Arthritis
Inflammatory arthritis is a recognized immune-related adverse event in patients treated with immune checkpoint inhibitors (ICIs) for cancer. Between 20% and 50% of affected patients experience more than... Read more
Microbiology
view channel
Genetic Marker Identifies Emerging Resistance to Frontline Malaria Drugs
Artemisinin-based combination therapy remains central to controlling Plasmodium falciparum malaria, but emerging drug resistance is complicating treatment and surveillance. In Uganda and across sub-Saharan... Read more
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
Pathology
view channel
AI-Pathologist Framework Improves Accuracy and Reliability in Cancer Diagnosis
Ensuring reliable cancer diagnosis from digital pathology remains a critical challenge as clinical decisions rely on accurate slide interpretation. While artificial intelligence (AI) has accelerated whole-slide... Read more
New Review Highlights Intelligent Agents as Next Step for Digital Pathology
Digital pathology remains constrained by models that classify single images without mirroring how clinicians interrogate multiple slides, adjust magnification, and synthesize ancillary tests.... Read more
Simple Immunohistochemical Size Ratio Improves Classification of Primary Aldosteronism
Primary aldosteronism is a common but underdiagnosed cause of hypertension, in which excess aldosterone promotes salt retention and raises blood pressure. Identifying the dominant source of hormone overproduction... Read more
Technology
view channel
Autonomous Robotic System Receives FDA Authorization for Blood Collection
Venipuncture is central to many diagnostic pathways, but routine blood collection can be affected by staffing constraints and procedural variability that influence consistency and patient experience.... Read more
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
Industry
view channel
New Collaboration Advances Precision Oncology Screening for Lung Cancer in Japan
Molecular profiling is central to precision oncology in lung cancer, but tissue samples can be limited and minimally invasive approaches are often preferable. Liquid biopsy enables blood-based genomic... Read more
