Assay design services

At New Day Diagnostics, we pride ourselves on being your comprehensive, concept-to-market partner for bringing pioneering diagnostic innovations to fruition. Our Assay Design Services are at the heart of our mission to empower lives through the development of groundbreaking diagnostics. With a focus on precision, reliability, and accessibility, we are dedicated to transforming your visionary diagnostic concepts into real-world solutions.

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assay design Components

Assay design is a fundamental process in the development of diagnostic tools, involving the creation of a method or procedure to measure the presence, amount, or functionality of an analyte within a biological sample. This process requires a deep understanding of biochemistry, molecular biology, and analytical chemistry, ensuring that the assay is not only sensitive and specific but also reproducible and scalable. Effective assay design lays the groundwork for the development of diagnostics that can accurately detect disease markers, guide treatment decisions, and monitor patient health. Under ISO 13485:2016 compliant Quality Management System, New Day Diagnostics has been designing and developing in vitro diagnostics for nearly two decades for our own products and for our clients. 

PHase 0: Opportunity Analysis 


Conceptualization & Feasibility Analysis

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

PHase 1: Assay feasibility

Analyte Selection & Characterization

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

Reagent Selection & Optimization

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

Protocol Development

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

PHase 2 & 3: analytical & clinical validation

Validation & Verification

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

PHase 4: Post launch

Scalability & Automation Assessment

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


what to look for in a contract service provider for

assay design

Choosing the right partner for assay design is critical. Here are essential attributes to consider:


A team with a broad range of expertise in biochemistry, molecular biology, analytical chemistry, and engineering ensures a comprehensive approach to assay design.


A provider that offers tailored assay design services to meet the unique needs and objectives of your project.


A partner that employs the latest technologies and methodologies to develop cutting-edge diagnostic assays.


Commitment to the highest standards of quality and adherence to regulatory guidelines throughout the assay development process.


Open and continuous communication, ensuring you are informed and engaged at every stage of assay design and development.



New Day Diagnostics is your end-to-end partner in the journey from concept to market. Our assay design services are a testament to our commitment to transforming diagnostic innovation into accessible solutions that empower lives. With a focus on precision, reliability, and partnership, we are dedicated to ensuring your diagnostic concept achieves its full potential.

Explore how our assay design services can bring your diagnostic innovation to life. Contact New Day Diagnostics today and take the first step towards realizing your vision.

New Day Diagnostics-Transforming Diagnostic Innovations, Empowering Lives.