Frontage can provide you with unmatched experience in biomarker assay development, validation, and sample analysis.

As your biomarker analysis partner, you can be assured of getting the optimal solution to address your needs at any part of your biomarker journey, for everything from custom and exploratory to regulated studies.

Frontage’s biomarker team is highly experienced in developing, qualifying, and validating biomarker assays.

We work in consultation with customers to develop a tiered approach to validation depending on the needs of the program or phase of development of the biomarker.

We can apply traditional and newer ELISA platforms as well as ultra-sensitive detection capabilities (Quanterix Simoa) for quantitation in the femtogram/mL range including single and multiplex analysis in various disease categories. 

When biomarkers are present at extremely low levels in the early stages of physiological abnormalities (i.e. well before the onset of disease symptoms) or when they are downregulated by therapeutic intervention, detection and quantification can enable early diagnosis and prediction of therapeutic effectiveness. However, too often traditional assay platforms cannot meet the required assay sensitivity needed. The sensitivity of the Quanterix Simoa analyzer makes it the instrument of choice for ultra-sensitive analysis of biomarkers. 

Assay Feature: pTau217

Frontage launches a new ultrasensitive assay for the quantitative determination of pTau217 in various sample types. The plasma phospho-Tau (pTau) species have emerged as the most promising blood-based biomarkers of Alzheimer’s disease.

Broad Range of Capabilities and Experience in Biomarker Assay Services 

Our biomarker scientists have developed and validated many biomarker assays for pharmaceutical and biotech companies. We are proud to become a benchmark in the field and have a significant impact on our clients using our expertise and state-of-the-art technology to advance/monitor drug development. We have also published novel biomarker assays developed in-house to share our expertise with the industry. With the addition of new technologies such as O-link and SMCxPRO for biomarker analysis, we believe we will continue as a top-notch provider of biomarker assay services in the years to come. 

Frontage’s Biomarker Areas of Expertise

• Fit-for-purpose (FFP) and Exploratory Biomarkers 
• Validation differences depending on the purpose of the study and method categories 
• Method validation to support Labelling Claims, Safety, Efficacy 
• Significant endogenous levels of biomarker(s) of interest 
• Parameters of validation and level of “compliance” (fit-for-purpose), methodology, and SOPs 
• Define assay precision & accuracy 
• Variety of platforms available (based on the endogenous biomarker amount in the matrix) 
• Shared samples for many biomarkers 
• Complexity around the analysis of “multiplex” data 
• Healthy vs Diseased performance differences 
• Potentially different locations, labs, companies, instrumentation, 
• Sample collection, processing, and shipping inconsistencies 
• Matrix selection & volume 

Molecule Types 

Platforms

Reagents 

• Commercially available assays 
• Homebrewed assays 

Key Experiments 

Therapeutically Focused Biomarkers 

Ten Reasons to pick Frontage as your Biomarker Study Partner 

We have a dedicated biomarker lab and additional capacity integrated into our bioanalytical lab and our central lab to achieve the following results: 

• Comes up with reasonable solutions in the most cost-effective way  
• Provides flexible timelines needed to meet sponsor’s unique program needs 
• Leverages the operational experience of Frontage’s bioanalytical and central labs 
• Provides a customized development and validation strategy for each project 
• Upholds the highest quality standards and necessary regulatory compliance and adherence to current industry guidelines such as 2018 FDA BMV and 2022 ICH M10 guidelines 
• Applies a tiered regulatory approach from fit-for-purpose (FFP) characterization to GLP/GCLP to CAP/CLIA 
• Accommodates all size study cohorts from low- or medium- to high-volume sample testing 
• Provides unmatched expertise in developing homebrew biomarker assays that are sensitive, robust, precise, and analytically appropriate 
• Delivers timely, high-quality results by combining our unique scientific capabilities, extensive QA expertise, and collaborative project management processes together 
• Supports all phases of large molecule global studies, from discovery through to Phase IV trials.