Companion Diagnostics (CDx) list

A CDx is an in-vitro diagnostic (IVD) medical device that provides information essential for the safe and effective use of a corresponding medicine or biological. 

The CDx framework came into effect on 1 February 2020. This was accompanied with the publication of the IVD companion diagnostics guidance.

Clinicians, laboratories, manufacturers and sponsors can use the table for clarity to:

• determine which IVDs are approved for use in Australia as a CDx and 
• medicines or biologicals that need CDx testing. 

This list includes information on commercial CDx IVDs approved under the framework after 1 February 2020. 

Not listed

• CDX testing required for older medicine or biological indications, if not yet approved or notified by TGA 
• IVDs approved before 1 February 2020. Until 26 May 2026, these can still be supplied under transitional arrangements. 
• In-house CDx (laboratory-developed). We plan to add them in the future. 

The list also includes medicines and biologicals that require CDx testing for which the TGA has not approved or been notified of any CDx for this purpose in Australia, and where the TGA assessed an associated companion testing plan during the approval process. 

For information on sample types used with each CDx IVD, see IVD ARTG link for the public summary document.

There will be regular updates to the list.