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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.
IVD companion diagnostic -name | IVD - ARTG | Biomarker | Corresponding medicine name (generic name) | Indication |
|---|---|---|---|---|
VENTANA PD-L1 (SP263) Assay | PD-L1 | IMFINZI (durvalumab) | Non-small cell lung cancer | |
VENTANA PD-L1 (SP263) Assay | PD-L1 | KEYTRUDA (pembrolizumab) | Non-small cell lung cancer | |
VENTANA PD-L1 (SP263) Assay | PD-L1 | OPDIVO (nivolumab) | Non-small cell lung cancer | |
VENTANA PD-L1 (SP263) Assay | PD-L1 | TECENTRIQ (atezolizumab) | Non-small cell lung cancer | |
VENTANA PD-L1 (SP142) Assay | PD-L1 | TECENTRIQ(atezolizumab) | Urothelial carcinoma | |
VENTANA HER2 Dual ISH DNA Probe Cocktail | HER2 | Herceptin (trastuzumab) | Breast cancer, Gastric cancer | |
VENTANA HER2 (4B5) - Rabbit Monoclonal Primary Antibody RxDx | HER2 | Herceptin (trastuzumab) | Breast cancer | |
VENTANA HER2 (4B5) - Rabbit Monoclonal Primary Antibody RxDx | HER2 | Perjeta (pertuzumab) | Breast cancer | |
VENTANA HER2 (4B5) - Rabbit Monoclonal Primary Antibody RxDx | HER2 | Kadcyla (trastuzumab emtansine) | Breast cancer | |
VENTANA HER2 (4B5) - Rabbit Monoclonal Primary Antibody RxDx | HER2 | Enhertu (FAM-trastuzumab deruxtecan-nxki) | Breast cancer | |
VENTANA HER2 (4B5) - Rabbit Monoclonal Primary Antibody RxDx | HER2 | Herceptin (trastuzumab) | Gastric cancer | |
VENTANA anti-PMS2 (A16-4) mouse monoclonal primary antibody (VENTANA MMR RxDx Panel) | PMS2 | KEYTRUDA (pembrolizumab) | MMR deficient solid tumours | |
VENTANA anti-PMS2 (A16-4) mouse monoclonal primary antibody (VENTANA MMR RxDx Panel) | PMS2 | KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) | MMR proficient endometrial carcinoma | |
VENTANA anti-MSH6 (SP93) rabbit monoclonal primary antibody (VENTANA MMR RxDx Panel) | MSH6 | KEYTRUDA (pembrolizumab) | MMR deficient solid tumours | |
VENTANA anti-MSH6 (SP93) rabbit monoclonal primary antibody (VENTANA MMR RxDx Panel) | MSH6 | KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) | MMR proficient endometrial carcinoma | |
VENTANA anti-MSH2 (G219-1129) mouse monoclonal primary antibody (VENTANA MMR RxDx Panel) | MSH2 | KEYTRUDA (pembrolizumab) | MMR deficient solid tumours | |
VENTANA anti-MSH2 (G219-1129) mouse monoclonal primary antibody (VENTANA MMR RxDx Panel) | MSH2 | KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) | MMR proficient endometrial carcinoma | |
VENTANA anti-MLH1 (M1) mouse monoclonal primary antibody (VENTANA MMR RxDx Panel) | MLH1 | KEYTRUDA (pembrolizumab) | MMR deficient solid tumours | |
VENTANA anti-MLH1 (M1) mouse monoclonal primary antibody (VENTANA MMR RxDx Panel) | MLH1 | KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) | MMR proficient endometrial carcinoma | |
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody | ALK | XALKORI (crizotinib) | Non-small cell lung cancer | |
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody | ALK | ZYKADIA (ceritinib) | Non-small cell lung cancer | |
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody | ALK | ALECENSA (alectinib) | Non-small cell lung cancer | |
Therascreen KRS RGQ PCR Kit | KRAS | LUMAKRAS (sotorasib) | Non-small cell lung cancer | |
PD-L1 IHC 28-8 pharmDx | PD-L1 | OPDIVO (nivolumab) | Esophageal squamous cell carcinoma | |
PD-L1 IHC 28-8 pharmDx | PD-L1 | Esophageal squamous cell carcinoma | ||
PD-L1 IHC 22C3 pharmDx (Dako Omnis) /GE006 | PD-L1 | KEYTRUDA (pembrolizumab) | Non-small cell lung cancer | |
PD-L1 IHC 22C3 pharmDx | PD-L1 | KEYTRUDA (pembrolizumab) | Non-small cell lung cancer, Head and neck squamous cell cancer, Triple-negative breast cancer, Cervical cancer and Gastric or GEJ | |
PD-L1 IHC 22C3 pharmDx | PD-L1 | LIBTAYO (cemiplimab) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | ALK | XALKORI (crizotinib) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | ALK | ALUNBRIG (brigatinib) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | BRAF | TAFINLAR (dabrafenib) in combination with MEKINIST (trametinib) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | EGFR L858R, exon 19 | IRESSA (gefitinib) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | EGFR exon 20 | RYBREVANT (amivantamab-vmjw) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | RET | RETEVMO (selpercatinib) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | RET | GAVRETO (pralsetinib) | Non-small cell lung cancer | |
Oncomine™Dx Target Test | ROS1 | XALKORI (crizotinib) | Non-small cell lung cancer | |
Droplex EGFR Mutation Test v2 | EGFR | TARCEVA (erlotinib) | Non-small cell lung cancer | |
Droplex EGFR Mutation Test v2 | EGFR | TAGRISSO (osimertinib) | Non-small cell lung cancer | |
Cobas 4800 BRAF V600 Mutation Test | BRAF V600 | ZELBORAF (vemurafenib) in combination with COTELLIC (cobimetinib) | Melanoma | |
| ConcizuTrace™ ELISA | 466665 | Concizumab (drug monitoring) | ALHEMO (concizumab) | Haemophili B congenital factor IX (FIX) deficiency with FIX inhibitors |