Immunosis plans to develop, register and commercialise Prim-Dx for patients who suffer from frequent infections to determine if they have PID. Immunosis will also explore ways to develop the technology for other immune related diseases, such as SID.
Our current clinical trial aims to build on our initial observations by increasing the number of patients used to train and validate the test.
A US regulatory consultant has been appointed to assist with a pre-submission to the US Food and Drug Administration.
Discussions are underway with a software developer to ensure Prim-Dx meets US regulatory requirements.
