Consultation: Companion diagnostics guidance update

While the consultation is open you can make a submission at our consultation hub.

We will review your submissions and publish them, along with our response, on the same consultation page.

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.

For further details about this consultation refer to the paper published on the TGA Consultation Hub and provide your feedback on the proposals.

The consultation will be open for feedback until Monday 17 June 2024. 

All recent consultations can be found on our TGA Consultation hub.