IVD and Companion Diagnostics
Clinexa has expertise and our team has experience in supporting In Virto Diagnostics (IVD) companies to develop their diagnostic products. Clinexa also has in-house Companion Diagnostics (CDx) Principal Investigator experience.
At Clinexa, we understand the complex regulatory and operational challenges to implement IVD and CDx studies. Our team has the expertise and experience to work as a team with the laboratories, pharmaceutical partners and IVD companies to bring diagnostic studies together. Based on the client’s requirements of utilizing a laboratory that does or does not operate under an accredited environment, Clinexa utilizes its network of commercial and research institutes-based laboratories in Australia to deploy diagnostic studies.
Our team has the necessary expertise to support the development of the biomarker strategy for a drug asset in development and the development of regulatory compliant CDx development plan.