In Vitro Diagnostics

Overcome barriers in assay development

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Overview

In vitro diagnostic (IVD) assay development is a complex and time-consuming process that demands meticulous attention and expertise at every stage. At GenScript, we provide a comprehensive suite of products and services designed to support researchers and developers through the intricate landscape of diagnostic development, ensuring success from initial concept to final commercialization.

This process is critical to producing high-quality reagents, which we can manufacture according to ISO 9001:2015 and ISO 13485. Our rigorous quality control procedures ensure the consistent performance and reliability of recombinant proteins, antibodies, and nucleic acids.

As diagnostic projects progress toward commercialization, GenScript continues to provide comprehensive support. We provide bulk reagent production and technical documentation, ensuring that developed diagnostics meet global standards. Our commitment extends beyond technical expertise; we offer tailored solutions that address specific project requirements while maintaining unparalleled quality control.

Experience our deep scientific expertise, unwavering commitment to quality, and ability to customize solutions for each unique challenge. Our team of experienced scientists and researchers brings extensive knowledge to every project, helping to accelerate IVD development and bring innovative diagnostic solutions to the market.

Application Solutions

In Vitro Diagnostics Workflow

Target
Identification 1

Assay Design &
Optimization 2

Assay Production &
Quality Control 3

Target Identification

The Target Identification stage is a critical foundational step in developing in vitro diagnostic (IVD) assays; it determines the biological markers to be detected and evaluates their feasibility for use in diagnostic applications. This assesses whether the selected target—such as a protein, antibody, or nucleic acid—can be accurately and reliably detected using the available diagnostic technology and resources. The target's relevance to the diagnosed disease or condition is also evaluated to ensure clinical applicability. This stage lays the groundwork for all subsequent development phases, making choosing appropriate biomarkers that align with the intended diagnostic goals essential.

Genomic Analysis

Protein Analysis

Assay Design & Optimization

Molecular, immunological, and cellular detection methods form the cornerstone of diagnostic technologies, each offering unique capabilities for identifying and quantifying biological targets. Molecular techniques like PCR enable precise genetic analysis, while immunological methods such as ELISA and lateral flow assays rapidly detect proteins, antibodies, and other molecular markers. Cellular assays offer deeper insights into biological interactions, making them invaluable in drug discovery, cancer research, and complex diagnostic investigations.

Antibody Detection

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Nucleic Acid Detection

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Antigen Detection

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Assay Production & Quality Control

Ensuring the validation of a diagnostic assay complies with local regulations is crucial. In the United States, the FDA's 510(k) trial mandates sample data collection for rigorous analysis, encompassing precision, accuracy, reportable range, reference range, analytic sensitivity, and analytic specificity evaluations. Furthermore, comprehensive quality control procedures are implemented to uphold long-term accuracy and reliability. These measures encompass continuous monitoring of assay performance, regular staff training, and other stringent protocols to enforce the highest quality assurance standards.

Please inquire regarding ISO 9001:2015 or ISO 13485 production needs.

Antibody Production

CRISPR

Custom DNA Oligo Synthesis

Custom Peptides

Protein Expression Service

Industry Insights

Webinar: Transforming Medicine: The Potential of Endothelial Cilia Proteins as Groundbreaking Biomarkers
Did you know endothelial cilia may be a powerful biomarker?

Cilia are microtubule-based organelles found in most cells in the body. Endothelial cilia are a known blood flow sensor and studies have identified that upon high shear stress, endothelial cilia get dismantled, a process called deciliation. On deciliation, proteins found inside a microtubule-based organelle called cilia are released into the blood. When these proteins from inside the cilium are spilled into blood, they stick to cells in blood, which can be detected by flow and immunoassays. These ciliary proteins can be observed in conditions where the underlying vasculature is weakened due to disturbed flow, showing promise for sickle cell anemia, traumatic brain injury, and Alzheimer’s Disease.

Learn about:
- The role of endothelial cilia as blood flow sensors and how the process of deciliation leads to the release of ciliary proteins into the bloodstream
- The development of assays, such as flow and immunoassays, for detecting ciliary proteins in human blood and other body fluids
- How the measurement of ciliary proteins can help predict short-term and long-term patient outcomes
Learn how to translate ciliary biology into diagnostic innovation!

Ramani Ramchandran, PhD
Professor, Medical College of Wisconsin
President and Founder, CIAN, Inc

2024 GenScript LSG Awardee
Blog Post: Optimizing Sensitivity in Antibody-Based Immunoassays: Key Strategies for Reliable Diagnostics
Summary:

Revisit our September article emphasizing the importance of sensitivity in antibody-based immunoassays for early disease detection and reliable diagnostics. We highlight the key factors influencing sensitivity, including antibody affinity and specificity, and discuss practical strategies to optimize sensitivity, such as selecting high-affinity antibodies, minimizing background noise, and enhancing signal detection. We also explore the significance of signal amplification and the appropriate detection system selection to maximize diagnostic assays' performance. You’ll also learn from GenScript’s real-world case study of their diagnostic development of the cPass™ SARS-Cov-2 Neutralization Antibody Detection assay.

Key takeaways:
- Importance of sensitivity: Sensitivity in antibody-based immunoassays is crucial for early detection of diseases and reliable diagnostics. It can help identify biomarkers at the earliest stages of a disease, allowing for timely intervention and improving patient outcomes.
- Factors influencing sensitivity: Antibody affinity and specificity are key factors that directly impact an assay's sensitivity. Optimizing these characteristics is fundamental to ensuring accurate detection of target biomarkers, even at very low concentrations.
- Strategies for optimizing sensitivity: The article explores practical strategies such as selecting high-affinity antibodies, minimizing background noise, and enhancing signal detection to maximize the performance of diagnostic assays. It also discusses the importance of signal amplification and choosing the exemplary detection system to improve the sensitivity and reliability of antibody-based immunoassays.
Read the full article