As the development of individualized medicine becomes more prominent, so does the need for IVD companion diagnostic (CDx) devices. Many developers find that this adds a layer of complexity required to simultaneously integrate the drug and diagnostic development and approval processes. To compound the challenge, the FDA is seeking to expand its regulatory oversight of Laboratory Developed Tests (LDTs). The agency’s oversight plan includes a formal notification process and medical device reporting requirements for LDTs that come into effect as soon as six months following the finalization of the guidance as well as a risk-based approach to phasing in pre-market and post-market requirements for LDTs.
Whether you need to develop IVD companion diagnostic devices to identify patients most likely to benefit from a therapeutic product, to identify patients most likely to be at increased risk for serious adverse events as a result of treatment from a therapeutic product, or to monitor patients’ responses to treatment with a therapeutic product, Beaufort is an indispensable ally. Our expertise in personalized medicine enables us to provide integrated therapeutic and diagnostic development solutions to support your diagnostic development.
- Biomarker assay verification and validation
- Clinical trial assay development
- CDx protocol design
- IRB submission and approval
- Regulatory submission preparation
- Investigational device exemption (IDE)
- 501(k) Premarket notification
- Premarket Approval Application (PMA)
- CE mark
- Quality System Regulation (21 CFR 820) compliance
- Preapproval inspection readiness