Assay Development & Optimization
TaliaGen partners with laboratories to design, develop, and optimize assays that are scalable, efficient, and inspection-ready. We begin with a comprehensive review of your laboratory’s goals, testing volume, and infrastructure to identify key success factors that support both current operations and future growth.
Our team builds and refines cost-effective, user-friendly workflows across both wet-lab and dry-lab operations, optimizing every stage of the testing process, including sample collection, nucleic acid extraction, instrument configuration, data analysis, and clinical reporting, to ensure accuracy, reproducibility, and operational efficiency.
Assay Validation
We provide end-to-end support for CLIA-compliant assay validation, guiding laboratories through planning, execution, and documentation. Our services include drafting comprehensive validation plans, sourcing appropriate validation materials, and executing both wet-lab and bioinformatics validations.
We compile complete validation packages, including validation reports, supporting documentation, Standard Operating Procedures (SOPs), and quality control checklists, ensuring your assay is fully documented, defensible, and ready for inspection and clinical use.
Training & Competency Assessment
TaliaGen delivers a three-tiered training program designed to ensure laboratory personnel are fully prepared to perform and maintain developed assays. Training covers both the theoretical foundations of each methodology and hands-on practical instruction in wet-lab and dry-lab environments.
We also conduct initial competency assessments for each assay, with active laboratory personnel present during validation, ensuring proper knowledge transfer, compliance, and long-term assay sustainability.
Why TaliaGen
Our approach combines regulatory expertise, operational efficiency, and real-world laboratory experience, enabling laboratories to launch validated assays with confidence, consistency, and compliance.