Companion diagnostics guidance update- public consultation

Overview

The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document.

The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including:

• A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion testing,
• An introduction to the concept of the ‘companion testing plan’ to recognise the CDx component evaluations undertaken as part of the medicine application.
• Improved clarity on clinical and analytical performance requirements for CDx, and
• Case studies to assist sponsors of medicines and devices on the regulatory process and the technical documentation required for an IVD CDx.

Responding to this Consultation

The draft guidance will be available for public consultation for 3 months (15 March 2024 – 17 June 2024).

Submissions in response to the consultation paper can be made through the online survey link below during this time period. You can right click on the consultation paper below and open a new tab to access the paper while going through the online survey.

Enquiries

Any questions relating to the consultation should be emailed to IVDs@tga.gov.au