Companion diagnostics (CDx) are designed to assist physicians in determining whether a patient might benefit from a particular therapy. CDx can be configured on many platforms, and takes advantage of molecular- or protein-based biomarkers that identify or track disease presence and progression. At Corgenix, we focus on assisting clients with a variety of tasks related to CDx development, including:
- Critical reagent development and characterization
- Identification of appropriate analytical platform(s)
- Feasibility studies
- RUO kit generation
- RUO-to-IUO bridging studies
- Correlation studies
- Regulatory support for IUO and IVD stages
- Strategic regulatory assistance to determine the least-burdensome path to market
- Assistance with regulatory agency interactions and submissions
Corgenix Regulatory Affairs has had frequent communication and interaction with CDRH and OIVD.
Many Corgenix employees have pharma and biotech experience, and have been involved in several small-molecule and biologic drug discovery, development, and manufacturing projects. They not only understand the needs and concerns of these teams – they understand the importance of developing a CDx that properly positions the drug for success.