CDx Process
Strategic Planning and Design
Asuragen’s companion diagnostic team will work with your organization to create a seamless project plan for every phase of development, from biomarker discovery to commercial launch of the companion diagnostic test. We have a deep understanding of our customer’s drug development process and can match that with our expertise in molecular diagnostic kit and test development to ensure success.
- Project design to meet overall goals and timelines based on our experience of integrating Dx/Rx development
- Early strategic regulatory planning
- Bioinformatic consultations to power your trial for success
Biomarker Discovery and Development for Diagnostics
Asuragen has extensive experience in biomarker discovery and development programs with existing pharmaceutical partners. We leverage our scientific know-how and best practices of successful biomarker development. Our Genomic Services Division offers unparalleled quality in DNA and RNA recovery from all sample types, such as FFPE tissue, blood, and needle biopsies.
- Capable of performing both unbiased and hypothesis driven/pre-selected biomarker studies
- Experienced bioinformatics team help select the best biomarkers for robust gene signature development
- Proven biomarker development capabilities including assays for: BCR/ABL, NPM1, KRAS, BRAF, HRAS, NRAS and PDAC (miRNA)
- Expertise in developing tests for multiple platforms and technologies including multiplexing capabilities
Assay Design and Validation (Analytical and Clinical)
Asuragen’s companion diagnostic team will work with your organization to design the assay to meet both specific analytical and clinical performance criteria.
- Assay platform migration experience such as microarrays to qRT-PCR
- Assay optimization and selection of controls and normalizers
- Good Laboratory Practice documentation throughout the assay development process
- Clinical testing in our CAP accredited CLIA laboratory during all clinical phases (I-III)
- Phase III Diagnostic Trial design for the PMA test submission
- Execution and management of the diagnostic trial arm of the companion diagnostic project
Regulatory
Our regulatory affairs department oversees all regulatory activities for companion diagnostic test development activities. We have in-depth experience for both FDA and CE marking of new kits and products as well as other countries (Japan, China, India, South America). The regulatory team engages early in the planning stages to understand the “Intended Use” of the test which will drive the development and regulatory processes. We can leverage our own diagnostic regulatory experience and provide the most up to date knowledge of the FDA and CE requirements as well best practices used in regulatory approvals.
- Understand the PMA requirements, CE marking
- cGMP manufacturing facility that is audited by the FDA and European regulatory authorities
- Understand diagnostic design control planning and execution
- Have performed Diagnostic Clinical Trials both is the US and Europe
- Experience in Companion Diagnostic regulatory submissions
Commercialization of Diagnostic Kits and Tests
Asuragen has a direct diagnostic sales force and an extensive distributor network worldwide for maximum commercial reach of diagnostic our kits and products.
- Understand diagnostic sales and marketing for “on label” claims of diagnostic kits and products
- Expertise in launching new tests and kits
- Expertise in the educational process of new tests
- Worldwide customers (laboratories, physicians)