Home / Seeking feedback on the updated draft Companion Diagnostics (CDx) Guidance document

Seeking feedback on the updated draft Companion Diagnostics (CDx) Guidance document

Industry News April 8, 2024

NATA team

The proposed updates are designed 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.

 Responses

The draft guidance will be available for public consultation for 3 months (15 March 2024 – 17 June 2024).

You can provide your feedback via the Online Survey 

Enquiries

If you have additional questions relating to the consultation, you can email to IVDs@tga.gov.au

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