Automated Imaging Speeds Up Infectious Disease Diagnosis
|
By LabMedica International staff writers Posted on 27 Oct 2016 |
|
Image: The Automated Plate Assessment System, or APAS, is a platform technology for the automation of culture-plate screening and interpretation (Photo courtesy of Clever Culture Systems).
Automated Plate Assessment System (APAS) is a breakthrough artificial intelligence technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation.
Thousands of agar plates are assessed in busy laboratories every day and currently each one has to be examined by a microbiologist for the presence of significant bacterial colonies. APAS automatically screens, interprets and sorts these plates, freeing up the plate reading bottleneck in laboratory workflows and microbiologists’ time and enabling faster time to patient results.
The US Food and Drug Administration (FDA, Silver Springs, MD, USA) have given 510(k) de novo submission clearance for the APAS as a class II device. The 510(k) de novo submission used a manual version of APAS to test 10,000 patients in a series of clinical trials conducted in Australia and the USA over a 12-month period. In each trial, APAS achieved its target primary endpoints and the results matched or exceeded the findings of a panel of experienced microbiologists.
The APAS was developed by LBT Innovations (Adelaide, Australia), and has been licensed on a global, exclusive basis to Clever Culture Systems AG (CCS, Bäch, Switzerland), which is integrating APAS with laboratory robotic instrumentation. CCS plans to bring APAS to market in 2017 as an automated stand-alone plate reader (APAS Independence) closely followed by the integrated incubator (APAS Incubot).
Brent Barnes, CEO of LBT Innovations, said, “FDA clearance follows rigorous interrogation and validation of the capabilities of APAS. The successful clinical trial program completed in 2015 and clearance by FDA also validate the underlying technology that is the core platform of our Company's vision to integrate imaging with interpretative intelligence to deliver faster and more secure diagnoses for patients. FDA clearance is a fitting tribute to the many years of painstaking work by LBT's staff and partners, who together have made our shared vision a reality.”
Related Links:
US Food and Drug Administration
LBT Innovations
CCS
Thousands of agar plates are assessed in busy laboratories every day and currently each one has to be examined by a microbiologist for the presence of significant bacterial colonies. APAS automatically screens, interprets and sorts these plates, freeing up the plate reading bottleneck in laboratory workflows and microbiologists’ time and enabling faster time to patient results.
The US Food and Drug Administration (FDA, Silver Springs, MD, USA) have given 510(k) de novo submission clearance for the APAS as a class II device. The 510(k) de novo submission used a manual version of APAS to test 10,000 patients in a series of clinical trials conducted in Australia and the USA over a 12-month period. In each trial, APAS achieved its target primary endpoints and the results matched or exceeded the findings of a panel of experienced microbiologists.
The APAS was developed by LBT Innovations (Adelaide, Australia), and has been licensed on a global, exclusive basis to Clever Culture Systems AG (CCS, Bäch, Switzerland), which is integrating APAS with laboratory robotic instrumentation. CCS plans to bring APAS to market in 2017 as an automated stand-alone plate reader (APAS Independence) closely followed by the integrated incubator (APAS Incubot).
Brent Barnes, CEO of LBT Innovations, said, “FDA clearance follows rigorous interrogation and validation of the capabilities of APAS. The successful clinical trial program completed in 2015 and clearance by FDA also validate the underlying technology that is the core platform of our Company's vision to integrate imaging with interpretative intelligence to deliver faster and more secure diagnoses for patients. FDA clearance is a fitting tribute to the many years of painstaking work by LBT's staff and partners, who together have made our shared vision a reality.”
Related Links:
US Food and Drug Administration
LBT Innovations
CCS
New
Gold Member
POC Helicobacter Pylori Test Kit
Hepy Urease Test
Thyroid Test
Anti-Thyroid EIA Test
New
Gold Member
Pre- Eclampsia Control
Acusera Pre-Eclampsia Control
Latest Technology News
- Training Device Improves Accuracy of Pooled Molecular Diagnostics
- New CE-Certified Software Advances Whole-Genome Cancer Testing
- National Rare Disease Registry Standardizes Genetic and Clinical Data for Coordinated Care
- AI Platform Links Biomarker Results to Cancer Clinical Trials and Guidelines
- Agentic AI Platform Supports Genomic Decision-Making in Oncology
- Algorithm Panel Aids Liver Fibrosis Assessment and Liver Cancer Surveillance
- Mailed Screening Kits Help Reduce Colorectal Cancer Screening Gaps
- AI-Enabled Assistant Unifies Molecular Workflow Planning and Support
- AI Tool Automates Validation of Laboratory Software Configuration Changes
- Point-of-Care Testing Enhances Health Literacy and Self-Management in Chronic Disease
- Fully Automated Sample-to-Insight Workflow Advances Latent TB Testing
- Tumor-on-a-Chip Platform Models Pancreatic Cancer Treatment Response
- New Platform Captures Extracellular Vesicles for Early Cancer Detection
- Microfluidic Single-Cell Assay Predicts Breast Cancer Risk
- AI Tool Predicts Non-Response to Targeted Therapy in Colorectal Cancer
- Integrated System Streamlines Pre-Analytical Workflow for Molecular Testing
Channels
Clinical Chemistry
view channel
New Machine-Learning Equation Improves LDL Cholesterol Assessment
Accurate assessment of low-density lipoprotein (LDL) cholesterol is central to cardiovascular risk management, yet calculation methods can underestimate values in some patients. Laboratories widely use... Read more
Blood Biomarker May Signal Cognitive Decline Risk a Decade Before Symptoms
Accurately identifying which cognitively healthy older adults will later develop impairment due to Alzheimer’s disease remains difficult, as brain scans and genetic testing provide only part of the risk picture.... Read more
Molecular Diagnostics
view channel
Blood-Based Biomarker Panel Outperforms Existing Liver Disease Tests
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a leading cause of chronic liver dysfunction, affecting about one in three adults. Diagnosis often occurs late and still relies in part... Read more
HPV Assay Gains Expanded CE Mark for Self-Collected Vaginal Samples
Cervical cancer is the fourth most common cancer in women and is largely preventable through vaccination and regular screening. However, even where organized screening programs exist, participation varies... Read more
Fully Automated Test Advances Hepatitis D Diagnosis and Monitoring
Hepatitis D virus infection can accelerate progression to cirrhosis and liver cancer, making timely diagnosis and longitudinal monitoring essential. Because hepatitis D depends on co-infection or superinfection... Read more
Blood Test Achieves Improved Detection of Advanced Precancerous Colorectal Lesions
Colorectal cancer is the second-leading cause of cancer-related death in the United States, yet screening uptake remains suboptimal. More than 50 million eligible adults are not up to date with recommended... Read moreHematology
view channel
New Biomarkers Predict Resistance to Targeted Therapy in Rare Blood Cancer
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and aggressive leukemia with limited treatment options and a poor prognosis. Although tagraxofusp is the first approved targeted therapy for... Read more
AI Decision Support System Guides Treatment Selection for Complex Blood Cancers
Treatment selection for hematologic malignancies often requires clinicians to synthesize clinical histories, genomic alterations, prior therapies, and rapidly evolving drug options. These complex decisions... Read more
Immunology
view channel
Cell-Free Assay Detects Functional IgE for Food Allergy Diagnosis
Accurately distinguishing sensitization from clinically relevant food allergy remains a challenge for laboratories, as routine blood tests detect allergen-specific immunoglobulin E (IgE) but not its capacity... Read more
Diagnostic Models Detect Hidden Eye Abnormalities After Mild COVID-19
Persistent ocular symptoms after COVID-19 can severely affect reading, work, and daily tasks, yet standard eye exams often reveal no clear abnormalities. Patients experiencing photophobia, eye pain, and... Read more
Anti-Lipid Antibody Biomarkers May Identify Early Lyme Disease and Persistent Symptoms
Lyme disease is often missed during its earliest and most treatable stage, while current serologic assays cannot distinguish active infection from prior exposure. Nearly half a million Americans are diagnosed... Read more
Pathology
view channel
Imaging Platform Maps Lipid Accumulations in Fabry Heart Tissue
Mapping the spatial distribution of disease-relevant molecules within tissue remains a diagnostic challenge, particularly before alterations are visible by conventional microscopy. In Fabry disease, a... Read more
AI Tissue Imaging Helps Guide Targeted Therapy for Lung Cancer
Lung cancer is the leading cause of cancer-related death, and many patients require rapid genotyping to guide targeted therapy selection. Current workflows often rely on molecular tests that are costly,... Read more
Technology
view channel
Training Device Improves Accuracy of Pooled Molecular Diagnostics
High-throughput molecular diagnostics have transformed infectious disease detection, but many workflows remain difficult to execute accurately without extensive training. Sample pooling can cut per‑test... Read more
New CE-Certified Software Advances Whole-Genome Cancer Testing
European hospitals are increasingly using comprehensive tumor genomics to guide therapy, but routine whole genome sequencing (WGS) requires validated, regulation-compliant workflows. A newly CE-certified... Read more
National Rare Disease Registry Standardizes Genetic and Clinical Data for Coordinated Care
Rare diseases collectively impose a significant clinical burden despite their individual rarity, often involving multisystem presentations and prolonged diagnostic journeys. Limited specialist expertise... Read more
Industry
view channel
Leica Biosystems to Expand Pathology Portfolio Through StatLab Acquisition
Leica Biosystems, an operating company of Danaher, has entered into a definitive agreement to acquire privately held StatLab Medical Products from Linden Capital Partners and Audax Private Equity.... Read more
