Molecular Assay Development Consulting Services
We take a comprehensive approach to assay development, guiding clients from method selection to final validation. Through our consulting services, we empower laboratories to implement high-quality molecular diagnostics with confidence. Let us help you bring your assay from concept to clinical application efficiently and effectively.
- Design and optimization of PCR, ddPCR, and sequencing assays.
- Method evaluation and selection tailored to your diagnostic platform.
- Lean workflow design for high-throughput testing.
Consulting Areas of Expertise
- Verification and validation studies to assess accuracy, precision, reproducibility, and limit of detection.
- Custom validation plans that align with FDA and ISO standards.
- Analytical and clinical performance evaluation.
- Support FDA submission processes, including EUA, 510(k), and PMA applications.
- Development of validation reports and submission-ready documentation.
- Support for labs looking to become CAP/CLIA accredited.
- Creation of SOPs and maintenance protocols for molecular diagnostic systems.
- Comprehensive quality assurance programs to meet ISO standards.
- Co-development opportunities for new assay technologies.
- Technical support for integrating innovative platforms into clinical workflows.