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ASSAY DESIGN & DEVELOPMENT SERVICES

An assay should be designed to be sensitive and specific, as well as reproducible and scalable, in order to lay the groundwork to develop a diagnostic that can accurately detect disease markers, guide treatment decisions, and monitor patient health. 

KEY COMPONENTS OF ASSAY DESIGN AND OUR SUPPORT 

Our comprehensive assay design services encompass every critical step to ensure the development of robust and reliable diagnostic assays. Our commitment to designing and developing quality assays begins with our ISO13485:2016 certified Quality Management System (QMS) coupled with our high standard of ethics and depth of scientific excellence.

Protocol Development

Crafting detailed assay protocols, including sample preparation, analyte detection, and signal measurement.

Validation and Verification

Conducting rigorous validation and verification tests to ensure the assay meets all performance requirements.

Scalability & Automation Assessment

Evaluating the assay’s potential for scalability and automation for high-throughput testing environments.

Conceptualization & Feasibility Analysis

Collaborating closely with clients to refine the diagnostic concept and evaluate its scientific and technical feasibility.

Analyte Selection & Characterization

Identifying and characterization the target analyte(s) for accurate and specific detection.

Reagent Selection & Characterization

Selecting and optimizing the best reagents for the assay to ensure sensitivity, specificity, and stability.

ASSAY DESIGN

At New Day Diagnostics, we are your dedicated partner in bringing groundbreaking diagnostic innovations to life. Through our comprehensive Assay Design & Development services, we ensure that your diagnostic solutions not only reach their full potential but also comply with the highest standards of ISO 13485 product design and development.