SelectScience
Join Free
Accelerating Science
NewsLife Sciences

Pre Diagnostics completes proof of concept study for its intracellular PreADx immunoassay for detection of Alzheimer’s Disease

Pre Diagnostics

Focusing on innate immunity opens way for precision medicine approaches to AD

23 Feb 2021
Diane Li
Assistant Editor

Industry news

Pre Diagnostics AS, a health tech company developing novel blood tests for neurodegenerative diseases, has announced that its PreADx immunoassay for early detection of Alzheimer’s Disease has successfully completed a clinical evaluation. The company now plans to further optimize the assay in advance of CE marking in Q2, 2021.

Unlike plasma or serum-based assays, PreADx takes an intracellular approach and measures the clearance of beta-amyloid peptides by analyzing a patient’s monocytes. The monocytes are a part of the innate immune system, and stem from the same cell lineage as the microglia and macrophages that clear plaques in the brain. In the blind evaluation of 62 well-characterized samples and controls from the Norwegian multicenter study “Dementia Disease Initiative”, PreADx achieved an ROC AUC of .81 in distinguishing healthy controls from Alzheimer patients. This is in line with the generally recognized threshold for diagnostic accuracy and opens the way for development of a much-needed new wave of early Alzheimer’s Disease assays.

“In both my clinical work and the Dementia Disease Initiative, I have seen the pressing need for more early diagnostic tools. I am pleased to see that the concept of extracting relevant information about neurodegenerative diseases from monocytes first discovered back in 2009, now has been validated in this study. I believe integrating AD diagnostics with innate immunity may also be helpful for precision medicine strategies ” comments Professor Tormod Fladby, MD PhD, main inventor and Head of the Department of Neurology at Akershus University Hospital.

“Beta-amyloid aggregation is generally considered the first pathological sign of the disease which is why we believe that a validated non-invasive immunoassay that can detect this will prove an invaluable front-line tool for improving Alzheimer’s Disease detection and treatment,” says Charlotte Berg-Svendsen, CCO, Pre Diagnostics AS.

“In preparation for CE marking we will now run further samples using an optimized version of the assay, which should also lead to increased accuracy. Further analysis will also give us a better picture of the potential clinical utility of this new biomarker, both alone and in combination with gender, ApoE and age.”

Want the latest science news straight to your inbox? Become a SelectScience member for free today>>

Links

Pre DiagnosticsCompany website

Tags

Cell Adhesion AssaysCell adhesion assays are used to quantitate attachment and analyze the molecular mechanisms for extracellular matrix adhesion, cell migration and sensitivity to inhibitors. Find the best cell adhesion assay equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Combinatorial ChemistryCombinatorial chemistry, also known as combichem, is a technique used in drug discovery to create libraries of structurally related compounds. A library is generated by synthesis with a chemical reactor system or by computer-based modeling of compound combinations. When undertaking combinatorial chemistry consider reagents, buffers, resins and standards.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. NeuroscienceNeuroscience research investigates the neurological mechanisms underlying behavior, neurodegenerative diseases, and other brain conditions. Learn about the innovative technologies for bioimaging, electrophysiology, cell culture, chromatography and other techniques used in this field.ImmunoassayImmunoassays are laboratory tests that utilize antibody-antigen interactions to detect specific substances. They are widely used in diagnostics for detecting diseases, drug testing, and environmental monitoring. These assays offer rapid, sensitive, and precise detection of biomarkers, making them invaluable in clinical and research labs. Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.Alzheimers ResearchAlzheimer�s disease is a neurodegenerative condition characterized by progressive memory loss and cognitive decline. Research focuses on understanding the molecular and cellular mechanisms of the disease, as well as developing effective treatments and diagnostic tools. Browse our peer-reviewed product directory to find the best Alzheimer�s research products, compare options, check reviews, and get pricing directly from manufacturers.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.

Related articles

Pre Diagnostics completes proof of concept study for its intracellular PreADx immunoassay for detection of Alzheimer’s Disease