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
.jpg)
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
Clinical Chemistry Assay
Sorbitol Dehydrogenase (SDH)
New
Specimen Collection Containers
Promed Containers
New
Respiratory 4-in-1 Panel
QuantiVirus SARS-CoV-2 & Flu AB Detection Test Kit
Latest Technology News
- 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
- Aptamer Biosensor Technology to Transform Virus Detection
Channels
Clinical Chemistry
view channel
Routine Blood Markers Predict Heart Failure Risk in Prediabetes
Heart failure prevention relies on finding high-risk adults before symptoms appear, yet effective stratification remains difficult in routine care. Prediabetes affects an estimated 115.2 million U.... Read more
First IVD Immunoassay to Detect Alzheimer’s Risk Gene Variant Receives CE Mark
Alzheimer’s disease accounts for up to 70% of dementia cases worldwide and is projected to affect nearly 150 million people by 2050, underscoring the need for scalable, accessible diagnostics.... Read more
Molecular Diagnostics
view channel
Liquid Biopsy Method Pinpoints Disease Source From a Single Drop of Blood
Liquid biopsy offers a noninvasive way to assess disease, but many assays still lack reliable tissue-of-origin localization and robust performance for early cancer detection. Researchers now report a method... Read more
Study Reveals Widespread Errors in Gene Variant Naming
Accurate variant nomenclature underpins the ability of clinical laboratories to retrieve and interpret evidence for rare disease diagnosis. Yet many patients face prolonged diagnostic journeys; in the U.... 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
Cancer Mutation ‘Fingerprints’ to Improve Prediction of Immunotherapy Response
Cancer cells accumulate thousands of genetic mutations, but not all mutations affect tumors in the same way. Some make cancer cells more visible to the immune system, while others allow tumors to evade... Read more
Immune Signature Identified in Treatment-Resistant Myasthenia Gravis
Myasthenia gravis is a rare autoimmune disorder in which immune attack at the neuromuscular junction causes fluctuating weakness that can impair vision, movement, speech, swallowing, and breathing.... Read more
New Biomarker Predicts Chemotherapy Response in Triple-Negative Breast Cancer
Triple-negative breast cancer is an aggressive form of breast cancer in which patients often show widely varying responses to chemotherapy. Predicting who will benefit from treatment remains challenging,... Read more
Blood Test Identifies Lung Cancer Patients Who Can Benefit from Immunotherapy Drug
Small cell lung cancer (SCLC) is an aggressive disease with limited treatment options, and even newly approved immunotherapies do not benefit all patients. While immunotherapy can extend survival for some,... Read morePathology
view channel
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
New Chromogenic Culture Media Enable Rapid Detection of Candida Infections
Invasive Candida infections are challenging for healthcare systems, with some strains spreading rapidly in hospitals and showing resistance to multiple antifungal drugs. Candida auris is associated with... Read more
Technology
view channel
New Electronic Pipette Enhances Workflows with Touchscreen Control
Manual pipetting remains a routine yet error-prone step that can affect reproducibility and throughput in clinical and research laboratories. Training demands and ergonomic strain also add variability... Read more
AI Model Outperforms Clinicians in Rare Disease Detection
Rare diseases affect an estimated 300 million people worldwide, yet diagnosis is often protracted and error-prone. Many conditions present with heterogeneous signs that overlap with common disorders, leading... Read more
AI-Driven Diagnostic Demonstrates High Accuracy in Detecting Periprosthetic Joint Infection
Periprosthetic joint infection (PJI) is a rare but serious complication affecting 1% to 2% of primary joint replacement surgeries. The condition occurs when bacteria or fungi infect tissues around an implanted... Read more
Industry
view channel
Automated MSI Test Gains IVDR Certification to Guide CRC Therapy
Treatment selection for metastatic colorectal cancer often requires knowledge of a tumor’s microsatellite instability (MSI) status. Timely results can help clinicians decide on immunotherapy options.... Read more
