NeuroKey-3™

A Fully Quantitative Multiplexed IP-MS Assay to Measure Key Low-Level Markers Linked to Neurodegeneration

Increase detection sensitivity for low-level

Neurodegeneration Biomarkers

The available treatments for neurodegenerative diseases are restricted, and the effective advancement of innovative therapeutics in the future, as well as the assessment of their effectiveness beyond traditional cognitive tests, will heavily depend on an optimal biomarker strategy for the identification, monitoring, and stratification of these diseases.

However, assay development and biomarker validation for current offerings is a costly and laborious process, most of which do not meet the criteria for regulatory submission.

To address these challenges, Inoviv developed NeuroKey-3™, a proprietary assay that utilizes analytical algorithms, workflows, and internal standards, providing high reproducibility, robustness, sensitivity, and a linear dynamic range over six orders of magnitude. This offers absolute quantification at low pg/ml concentration following immunoprecipitation-based enrichment (IP-MS) in a hybrid assay format.

Associated with cognitive decline and involved in synaptic plasticity

Xiang, Yang et al. “Neurogranin: A Potential Biomarker of Neurological and Mental Diseases.” Frontiers in aging neuroscience vol. 12 584743. 6 Oct. 2020, doi:10.3389/fnagi.2020.584743
Liu, W., Lin, H., He, X. et al. Neurogranin as a cognitive biomarker in cerebrospinal fluid and blood exosomes for Alzheimer’s disease and mild cognitive impairment. Transl Psychiatry 10,125 (2020). https://doi.org/10.1038/s41398-020-0801-2

Essential in neuronal survival & growth

Bathina, Siresha, and Undurti N Das. “Brain-derived neurotrophic factor and its clinical implications.” Archives of medical science : AMS vol. 11,6 (2015): 1164-78. doi:10.5114/aoms.2015.56342

Mediates neuroinflammation in the CNS

Felderhoff-Mueser, Ursula et al. “IL-18: a key player in neuroinflammation and neurodegeneration.” Trends in neurosciences vol. 28,9 (2005): 487-93. doi:10.1016/j.tins.2005.06.008

Accelerating Clinical Trial Timelines

Obtain definitive insights into your research goals

End-to-End Solution

The Biomarker Strategy for Success

Measure proteins which pharmaceutical companies care about, at the precision needed to enable decision-making and FDA submissions in three easy steps

Send
Samples

After designing your custom experimental assay with our with our proteomics experts, send your human plasma samples to our CLIA, FDA inspected (US) or GCP/GLP (UK) certified labs

Bioinformatics and Validation

After processing samples, our bioinformatics team analyzes data through proprietary analytical algorithms, workflows and internal standards to provide the highest possible reproducibility and robustness following FDA bioanalytical guidelines. 

Clinical Utility

Proceed to clinical trials or laboratory developed tests (LDT) if needed. We offer extended validation for exploratory & secondary end points.