Diagnostic Assay Support
Cross-validation of diagnostic assays and the development of companion diagnostics require advanced technologies such as qPCR, ddPCR, NGS, and Sanger sequencing. These technologies, some of which are considered “gold standards,” are mandated by the FDA to ensure the accuracy, reliability, and clinical utility of novel diagnostic assays. For companion diagnostics, these validated assays are crucial when seeking approval for new drugs or therapies, as they reliably identify patient subgroups most likely to benefit from the treatment.
Our Expertise
Leveraging the power of genomics, cell biology, microbiology, immunoassays, and other advanced technologies, Avance Biosciences has extensive experience providing support for the development and validation of diagnostic assays and companion diagnostics. Our comprehensive approach ensures precise, reliable, and clinically relevant results, facilitating the advancement of personalized medicine and improving patient outcomes.
Diagnostic Assay Support Services
Diagnostic Assay Cross Validation:
- Genomic Technologies: Utilizing “Gold-Standard” technologies, such as NGS, ddPCR, and qPCR, we provide robust validation for diagnostic assays, ensuring they meet regulatory standards and clinical requirements.
- Custom Solutions: Tailored validation protocols to meet the specific needs of your diagnostic assays, ensuring accuracy, sensitivity, and specificity.
Companion Diagnostics Development and Validation:
- Targeted Approach: Developing companion diagnostics that identify patient subgroups likely to benefit from specific therapies, enhancing treatment efficacy and safety.
- Advanced Analytics: Applying bioinformatics and machine learning to interpret complex data, providing actionable insights for companion diagnostics.
Quality Assurance
- Rigorous quality control processes (GLP) to ensure the highest standards of data integrity and reproducibility