For clinical development programs that need biomarker detection with high sensitivity and broad dynamic range, Precision uses the Quanterix SIMOA platform. The SIMOA SR-X platform can deliver 1000-fold higher sensitivity than traditional ELISAs, yielding analyte detection in the femtomolar (fM) range and enabling analysis of previously difficult or even impossible-to-quantify biomarkers, such as CNS-specific or -derived biomarkers in serum and plasma as well as ultrasensitive PK assays for early dose escalation trials.
Additionally, high sensitivity detection allows for the discovery of new biomarkers, creating opportunities for the development of novel diagnostics and companion diagnostics.
Gold standard biomarkers in neurology therapeutic development
Discover biomarker approaches specific to neurology therapeutic development, including how SIMOA assays can be used for measurement of CNS-specific biomarkers in blood.
Ultra-sensitive biomarker detection using Quanterix SIMOA
Advancing biomarker-driven research through femtomolar detection and quantification of low abundance or challenging biomarkers
Example uses of Quanterix SIMOA
- Biomarker discovery: quantify previously unmeasurable proteins and nucleic acids
- Uncover Dx and CDx opportunities
- Protein counting in single cancer cells
- Measurement of neurology biomarkers in matrices other than CSFm
- PK/ADA assays (gene therapy)
Sample types analyzed:
- Cell extracts
Selection of key biomarkers targets and uses
- NfL: neurodegeneration biomarker in multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer’s disease, and other indications
- Tau: Alzheimer’s disease, frontotemporal dementia
- Aβ42, Aβ40: Alzheimer’s disease, frontotemporal dementia
- UCHL1, NfL, Tau, GFAP: traumatic brain injury, stroke
- Gene Therapy:
- AAV antibodies: TAb assays in gene therapy
- Transgene products
- Cytokine panels
- Inflammatory proteins
Neurology applications of SIMOA technology
Historically, several important neurology biomarkers, including neurofilament light chain (NfL) and phosphorylated neurofilament heavy chain (P-NfH) could only be reliably measured in cerebrospinal fluid (CSF). Plasma/serum (or blood) concentrations of these biomarkers are too low for detection using standard ELISA methods.
Utilizing the 1000-fold higher sensitivity of the SIMOA platform, Precision can reliably measure these biomarkers from blood draws, offering significant benefits in neurology studies:
- Lower patient burden – Sampling CSF can be challenging and is associated with higher patient discomfort and an increased risk of complications. In contrast, blood draws are easier on patients and have a lower risk of complications.
- Improved longitudinal data – Because blood draws are more accessible, samples may be collected more frequently and in larger volumes than when sampling CSF. This helps build a richer and more informative biomarker data set over time for each patient and across patients.
Integrating biomarker and clinical trial data
To help researchers understand and interpret biomarker assay data in the context of other assays as well as the clinical trial data, Precision provides the option of managing and analyzing assay data using our proprietary QuartzBio Translational Informatics platform.
Global reach, multi-site support
We provide Quanterix SIMOA services that support pre-clinical and clinical research, including multi-site studies, conducted anywhere in the world. Samples are processed within 24 to 30 hours of draw and utilize standardized SOPs to ensure sample integrity.
Working with Precision
Precision’s specialty lab scientists take a collaborative and consultative approach to projects and can provide recommendations on biomarker assay strategies and implementation.
Services can be provided individually or as part of a comprehensive therapeutic development package including biomarker assays and clinical trials.
MesoScale Discovery (MSD) Assays
Measure a range of analytes in complex samples matrices consistently and at high sensitivity with our MSD assay capabilities. Applications include ADA, NAb, and TAb assays, PK assays, and more.
ELISA is generally recognized as a gold standard for quantitative, antibody-based analysis. Precision’s ELISA services include assay development or transfer, validation, and implementation.
We offer assay development, validation, and implementation using ELISAs and MesoScale Discovery (MSD) assays for biologics; flow cytometry and Droplet Digital™ PCR (ddPCR) for cell-based therapies; and Quanterix SIMOA® for ultrasensitive detection.