Companion diagnostics and assays
Cut-offs gate every biomarker-selected drug: PD-L1 CPS 10, HER2 IHC 1+ or 2+, MSI-high, TMB 10 and the rest. 38 assays (35 FDA companion diagnostics) with vendor, platform, analyte, the exact threshold, the products and cancers they gate, and the tumour-board biomarker they correspond to.
38 assays
| Analyte | Cut-off that gates therapy | Gates | Cancers | Target dossier | Tumour-board biomarker | Source | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| IDH1 R132 mutations (C, G, H, L, S) | Mutation detected (ivosidenib, AML) | Ivosidenib | Acute myeloid leukaemia | IDH1 / IDH2 | 2018 | IDH1 / IDH2 mutation | FDA CDx list | |||
| IDH2 R140 and R172 mutations | Mutation detected (enasidenib, AML) | Enasidenib | Acute myeloid leukaemia | IDH1 / IDH2 | 2017 | IDH1 / IDH2 mutation | FDA CDx list | |||
| Circulating tumour DNA: 109 genes | KRAS G12C detected (adagrasib, NSCLC) | Adagrasib | Non-small-cell lung cancer | KRAS | 2022 | KRAS G12C | FDA CDx list | |||
BRACAnalysis CDx Myriad Genetics The first companion diagnostic for a PARP inhibitor (olaparib, December 2014) and the first germline companion diagnostic. | Germline BRCA1 and BRCA2 sequence and large rearrangements | Deleterious or suspected deleterious germline variant | Olaparib, Talazoparib, Rucaparib, Niraparib | Ovarian cancer, HR-positive / HER2-negative breast cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Prostate cancer | BRCA1 / BRCA2, PARP | 2014 | Germline BRCA1/2 (or PALB2) | FDA CDx list | ||
| BRAF V600E (and cross-reactive V600K/D) | V600 mutation detected | Vemurafenib, Cobimetinib | Melanoma | BRAF | 2011 | BRAF V600E | FDA CDx list | |||
cobas EGFR Mutation Test v2 Roche Molecular Systems The plasma claim (2016) made it the first FDA-approved liquid biopsy companion diagnostic. | EGFR exon 19 deletions, L858R, T790M and other exon 18 to 21 mutations (tissue and plasma) | Mutation detected (qualitative); plasma negative result should be reflexed to tissue | Erlotinib, Gefitinib, Osimertinib | Non-small-cell lung cancer | EGFR | 2013 | EGFR activating mutation (ex19del / L858R) | FDA CDx list | ||
EGFR pharmDx Agilent (Dako) A historical example of a companion diagnostic that did not predict benefit: EGFR IHC was dropped from practice once RAS status proved to be the real selector. | EGFR protein | Any EGFR membrane staining (historic requirement for cetuximab and panitumumab in colorectal cancer) | Cetuximab, Panitumumab | Colorectal cancer, Head and neck squamous cell carcinoma | EGFR | 2004 | none | FDA CDx list | ||
FoundationFocus CDxBRCA Foundation Medicine The first NGS-based companion diagnostic approved by the FDA. | Tumour BRCA1/2 (somatic and germline) sequence alterations | Deleterious BRCA1/2 alteration (rucaparib, ovarian cancer) | Rucaparib | Ovarian cancer | BRCA1 / BRCA2, PARP | 2016 | Germline BRCA1/2 (or PALB2); HRD positive (genomic scar) | FDA CDx list | ||
FoundationOne CDx Foundation Medicine (Roche) The first pan-tumour NGS companion diagnostic (November 2017); most new targeted-therapy approvals add a claim to it rather than launch a single-gene kit. | 324 genes: mutations, copy number, selected fusions; MSI and TMB | Per companion claim: EGFR, ALK, BRAF V600, ERBB2 amplification, KRAS wild-type, BRCA1/2 and HRR genes, PIK3CA, MET exon 14, RET, FGFR2 fusions, IDH1, NTRK fusions; MSI-high; TMB at least 10 mutations per megabase | Osimertinib, Alectinib, Dabrafenib + trametinib, Trastuzumab, Cetuximab, Olaparib, Rucaparib, Talazoparib, Alpelisib, Capmatinib & tepotinib, Selpercatinib, Pemigatinib, Ivosidenib, Larotrectinib, Pembrolizumab | Non-small-cell lung cancer, Melanoma, HER2-positive breast cancer, Colorectal cancer, Ovarian cancer, Prostate cancer, HR-positive / HER2-negative breast cancer, Biliary tract cancer, Thyroid cancer | EGFR, ALK, BRAF, HER2, KRAS, BRCA1 / BRCA2, PARP, PIK3CA / PI3K-alpha, MET, RET, FGFR2, IDH1 / IDH2, NTRK, PD-1 | 2017 | EGFR activating mutation (ex19del / L858R); ALK fusion; BRAF V600E; HER2 IHC 3+ / amplified; KRAS G12C; Germline BRCA1/2 (or PALB2); HRD positive (genomic scar); PIK3CA mutation; MET exon 14 skipping or amplification / c-MET overexpression; RET fusion or mutation; FGFR2 fusion (or FGFR3 alteration); IDH1 / IDH2 mutation; NTRK fusion; TMB ≥ 10 mut/Mb; MSI-high / dMMR | FDA CDx list | ||
FoundationOne Liquid CDx Foundation Medicine (Roche) Per companion claim: EGFR (osimertinib, erlotinib, gefitinib), ALK (alectinib), BRCA1/2 and ATM (olaparib, rucaparib), PIK3CA (alpelisib), FGFR3 (erdafitinib), NTRK and RET; negative plasma results reflex to tissue | Circulating tumour DNA: more than 300 genes | Per companion claim: EGFR (osimertinib, erlotinib, gefitinib), ALK (alectinib), BRCA1/2 and ATM (olaparib, rucaparib), PIK3CA (alpelisib), FGFR3 (erdafitinib), NTRK and RET; negative plasma results reflex to tissue | Osimertinib, Alectinib, Olaparib, Rucaparib, Alpelisib, Erdafitinib | Non-small-cell lung cancer, Prostate cancer, Ovarian cancer, HR-positive / HER2-negative breast cancer, Bladder & urothelial cancer | EGFR, ALK, BRCA1 / BRCA2, PIK3CA / PI3K-alpha, FGFR2, NTRK, RET | 2020 | EGFR activating mutation (ex19del / L858R); ALK fusion; Germline BRCA1/2 (or PALB2); PIK3CA mutation; FGFR2 fusion (or FGFR3 alteration) | FDA CDx list | ||
Guardant360 CDx Guardant Health The first FDA-approved liquid NGS companion diagnostic (August 2020); the ESR1 claim (2023) made ctDNA the standard route to elacestrant eligibility. | Circulating tumour DNA: 55 to 74 genes | Per companion claim: EGFR (osimertinib), EGFR exon 20 insertions (amivantamab), KRAS G12C (sotorasib), ESR1 mutations (elacestrant), ERBB2 mutations (zongertinib); negative plasma reflexes to tissue | Osimertinib, Amivantamab, Sotorasib, Elacestrant, Zongertinib | Non-small-cell lung cancer, HR-positive / HER2-negative breast cancer | EGFR, KRAS, Estrogen receptor, HER2 | 2020 | EGFR activating mutation (ex19del / L858R); EGFR exon 20 insertion; KRAS G12C; ESR1 mutation (ctDNA) | FDA CDx list | ||
HER2 IQFISH pharmDx and INFORM HER2 Dual ISH Agilent; Roche Diagnostics Resolves IHC 2+ cases; the ASCO/CAP groups 2 to 4 (unusual ratio and copy-number combinations) are where results differ between laboratories. | ERBB2 gene copy number | HER2/CEP17 ratio at least 2.0, or ratio below 2.0 with average HER2 copy number at least 6.0 (ASCO/CAP 2018) | Trastuzumab, Pertuzumab, Trastuzumab emtansine | HER2-positive breast cancer, Gastric & gastro-oesophageal junction cancer | HER2 | none | HER2 IHC 3+ / amplified | FDA CDx list | ||
HercepTest Agilent (Dako) The first companion diagnostic (with trastuzumab, 1998). Its scoring scale was built to find amplification; the HER2-low and ultralow claims added in 2022 and 2025 stretch it to the bottom of the range, where reproducibility is weakest. | HER2 protein | IHC 3+ (or 2+ confirmed by ISH) for trastuzumab; IHC 1+ or 2+/ISH-negative (HER2-low) for trastuzumab deruxtecan; IHC 0 with faint membrane staining (HER2-ultralow) for trastuzumab deruxtecan in HR-positive breast cancer | Trastuzumab, Pertuzumab, Trastuzumab emtansine, Trastuzumab deruxtecan, Tucatinib | HER2-positive breast cancer, HR-positive / HER2-negative breast cancer, Gastric & gastro-oesophageal junction cancer | HER2 | 1998 | HER2 IHC 3+ / amplified; HER2-low (IHC 1+ or 2+/ISH−); HER2-ultralow (IHC 0 with faint staining) | FDA CDx list | ||
Ki-67 IHC (MIB-1) Multiple (Agilent, Roche, Leica) Ki-67 scoring varies by antibody, hotspot versus global counting and laboratory; the International Ki-67 Working Group validated only the extremes (below 5%, above 30%). | Ki-67 proliferation index | At least 20% (monarchE high-risk cohort; the abemaciclib label's Ki-67 requirement was removed in 2023) | Abemaciclib | HR-positive / HER2-negative breast cancer | CDK4/6 | 2021 | ER positive | FDA CDx list | ||
LeukoStrat CDx FLT3 Mutation Assay Invivoscribe The signal ratio cut-off, not simply presence, defines eligibility, and the ratio also carries prognostic weight in ELN risk classification. | FLT3 internal tandem duplication and D835/I836 tyrosine-kinase-domain mutations | ITD signal ratio at least 0.05 or TKD mutation detected (midostaurin, gilteritinib); ITD only for quizartinib | Midostaurin, Gilteritinib, Quizartinib | Acute myeloid leukaemia | FLT3 | 2017 | none | FDA CDx list | ||
MSI by PCR (Promega MSI Analysis System and equivalents) Promega and others Pembrolizumab's 2017 tumour-agnostic approval for MSI-high or dMMR cancer was granted without a named companion device; IHC, PCR and NGS are all accepted in practice. | Microsatellite instability at five mononucleotide markers | Instability at two or more of five markers (MSI-high); NGS panels report MSI from hundreds of loci | Pembrolizumab, Nivolumab, Ipilimumab, Dostarlimab | Colorectal cancer, Endometrial cancer, Gastric & gastro-oesophageal junction cancer | PD-1, CTLA-4 | none | MSI-high / dMMR; Lynch syndrome (germline MMR) | Le et al., NEJM 2015 | ||
myChoice CDx Myriad Genetics A scar assay: it records past homologous-recombination deficiency and stays positive after reversion restores repair. | Tumour BRCA1/2 status plus genomic instability score (loss of heterozygosity, telomeric allelic imbalance, large-scale state transitions) | Genomic instability score at least 42, or BRCA1/2 mutation, defines HRD-positive (olaparib plus bevacizumab, PAOLA-1; niraparib) | Olaparib, Niraparib, Bevacizumab | Ovarian cancer | BRCA1 / BRCA2, PARP | 2019 | HRD positive (genomic scar); Germline BRCA1/2 (or PALB2) | FDA CDx list | ||
Oncomine Dx Target Test Thermo Fisher Scientific Runs on small biopsies with both DNA and RNA, which is why it carries fusion claims. | 23 genes (DNA and RNA) in NSCLC | Per companion claim: BRAF V600E (dabrafenib plus trametinib), ROS1 fusions (crizotinib), EGFR (gefitinib), RET fusions (pralsetinib), MET exon 14 (tepotinib), EGFR exon 20 insertions | Dabrafenib + trametinib, Crizotinib, Gefitinib, Pralsetinib, Capmatinib & tepotinib | Non-small-cell lung cancer | BRAF, ROS1, EGFR, RET, MET | 2017 | BRAF V600E; EGFR activating mutation (ex19del / L858R); RET fusion or mutation; MET exon 14 skipping or amplification / c-MET overexpression; EGFR exon 20 insertion | FDA CDx list | ||
Oncotype DX Breast Recurrence Score Exact Sciences Not an FDA companion diagnostic; a laboratory-developed test whose cut-offs were set prospectively by randomised trials. | 21-gene RT-PCR signature | Recurrence score 0 to 25 (postmenopausal, node-negative or 1 to 3 nodes): chemotherapy can be omitted (TAILORx, RxPONDER); premenopausal 16 to 25: benefit from chemotherapy | Oncotype DX, Tamoxifen, Letrozole | HR-positive / HER2-negative breast cancer | Estrogen receptor | none | ER positive | TAILORx, NEJM 2018 | ||
PATHWAY anti-HER2/neu (4B5) Roche Diagnostics IHC 3+ (HER2-positive); IHC 1+ or 2+/ISH-negative (HER2-low) for trastuzumab deruxtecan; IHC 3+ solid tumours for tumour-agnostic trastuzumab deruxtecan | HER2 protein | IHC 3+ (HER2-positive); IHC 1+ or 2+/ISH-negative (HER2-low) for trastuzumab deruxtecan; IHC 3+ solid tumours for tumour-agnostic trastuzumab deruxtecan | Trastuzumab, Trastuzumab deruxtecan, Trastuzumab emtansine | HER2-positive breast cancer, HR-positive / HER2-negative breast cancer, Gastric & gastro-oesophageal junction cancer, Colorectal cancer | HER2 | none | HER2 IHC 3+ / amplified; HER2-low (IHC 1+ or 2+/ISH−) | FDA CDx list | ||
PD-L1 IHC 22C3 pharmDx Agilent (Dako) The first PD-L1 companion diagnostic, approved with pembrolizumab in second-line NSCLC in October 2015; the scoring system (TPS then CPS) grew indication by indication. | PD-L1 protein (tumour and immune cells) | TPS at least 1% or at least 50% (NSCLC); CPS at least 1 (head and neck, oesophageal, gastric); CPS at least 10 (TNBC, gastric first line); CPS at least 1 (cervical) | Pembrolizumab | Non-small-cell lung cancer, Head and neck squamous cell carcinoma, Oesophageal cancer, Gastric & gastro-oesophageal junction cancer, Triple-negative breast cancer, Cervical cancer, Bladder & urothelial cancer | PD-L1, PD-1 | 2015 | PD-L1 CPS ≥ 10 (22C3); PD-L1 TPS ≥ 50% (lung) | FDA CDx list | ||
PD-L1 IHC 28-8 pharmDx Agilent (Dako) Originally a complementary (not required) test with nivolumab; became a companion diagnostic for the CheckMate 227 combination. | PD-L1 protein (tumour-cell scoring) | TC at least 1% (nivolumab plus ipilimumab, first-line NSCLC) | Nivolumab, Ipilimumab | Non-small-cell lung cancer, Melanoma | PD-L1, PD-1 | 2020 | PD-L1 TPS ≥ 50% (lung) | FDA CDx list | ||
PSMA PET (Ga-68 PSMA-11, F-18 piflufolastat, F-18 flotufolastat) Novartis, Lantheus, Blue Earth Diagnostics Ga-68 PSMA-11 is the first imaging agent listed by the FDA as a companion diagnostic; PSMAfore later relaxed the VISION exclusion rules. | PSMA expression on PET | At least one PSMA-positive lesion and no dominant PSMA-negative lesion (VISION criteria) for lutetium-177 PSMA-617 | Lutetium-177 vipivotide tetraxetan, Gallium-68 gozetotide, Piflufolastat F-18 / Pylarify TruVu, Flotufolastat F-18 | Prostate cancer | PSMA | 2022 | PSMA PET positive | FDA CDx list | ||
Signatera (tumour-informed ctDNA MRD) Natera Medicare-covered as a laboratory-developed test; the first assay to select adjuvant immunotherapy by molecular residual disease in a positive phase 3 trial. | 16 patient-specific somatic variants tracked in plasma | Two or more variants detected above the assay threshold defines ctDNA-positive (IMvigor011: adjuvant atezolizumab for ctDNA-positive bladder cancer) | Signatera, Atezolizumab | Bladder & urothelial cancer, Colorectal cancer, HR-positive / HER2-negative breast cancer | PD-L1 | none | ctDNA MRD positive after curative treatment | FDA CDx list | ||
therascreen BRAF V600E RGQ PCR Kit QIAGEN V600E detected (colorectal cancer, encorafenib plus cetuximab) | BRAF V600E | V600E detected (colorectal cancer, encorafenib plus cetuximab) | Encorafenib, Cetuximab | Colorectal cancer | BRAF, EGFR | 2020 | BRAF V600E | FDA CDx list | ||
| EGFR exon 19 deletions, L858R, T790M, G719X, S768I, L861Q, exon 20 insertions | Mutation detected (qualitative) | Afatinib, Gefitinib, Dacomitinib | Non-small-cell lung cancer | EGFR | 2013 | EGFR activating mutation (ex19del / L858R); EGFR exon 20 insertion | FDA CDx list | |||
| FGFR3 point mutations (R248C, S249C, G370C, Y373C) and FGFR2/FGFR3 fusions | Alteration detected (erdafitinib, urothelial carcinoma) | Erdafitinib | Bladder & urothelial cancer | FGFR2 | 2019 | FGFR2 fusion (or FGFR3 alteration) | FDA CDx list | |||
therascreen KRAS RGQ PCR Kit QIAGEN Started life as a negative selector (no anti-EGFR antibody if KRAS mutant) and became a positive selector for the G12C inhibitors in 2021 and 2022. | KRAS codon 12, 13 and 61 mutations including G12C | Wild-type required for cetuximab or panitumumab (colorectal); G12C detected for sotorasib and adagrasib (NSCLC) | Cetuximab, Panitumumab, Sotorasib, Adagrasib | Colorectal cancer, Non-small-cell lung cancer | KRAS, EGFR | 2012 | KRAS G12C; KRAS G12D (or other non-G12C KRAS) | FDA CDx list | ||
therascreen PIK3CA RGQ PCR Kit QIAGEN Mutation detected (alpelisib plus fulvestrant); plasma negative reflexes to tissue | 11 PIK3CA mutations in exons 7, 9 and 20 (tissue or plasma) | Mutation detected (alpelisib plus fulvestrant); plasma negative reflexes to tissue | Alpelisib | HR-positive / HER2-negative breast cancer | PIK3CA / PI3K-alpha | 2019 | PIK3CA mutation | FDA CDx list | ||
| BRAF V600E and V600K | V600E or V600K detected | Dabrafenib + trametinib | Melanoma | BRAF | 2013 | BRAF V600E | FDA CDx list | |||
Tumour mutational burden (FoundationOne CDx and equivalents) Foundation Medicine and others Panel size, germline filtering and the mutation types counted all shift the number; the Friends of Cancer Research TMB harmonisation project exists because 10 on one panel is not 10 on another. | Non-synonymous mutations per megabase across the panel | At least 10 mutations per megabase (pembrolizumab, tumour-agnostic, KEYNOTE-158) | Pembrolizumab | Melanoma, Non-small-cell lung cancer, Bladder & urothelial cancer, Endometrial cancer | PD-1 | 2020 | TMB ≥ 10 mut/Mb | FDA CDx list | ||
VENTANA ALK (D5F3) CDx Assay Roche Diagnostics Cheaper and faster than FISH; became the routine screening method in most pathology departments. | ALK protein (surrogate for rearrangement) | Binary: strong granular cytoplasmic staining in any tumour cells is positive | Crizotinib, Alectinib, Brigatinib, Lorlatinib, Ceritinib | Non-small-cell lung cancer | ALK | 2015 | ALK fusion | FDA CDx list | ||
VENTANA CLDN18 (43-14A) RxDx Assay Roche Diagnostics The antibody detects CLDN18 regardless of isoform; specificity for 18.2 relies on 18.1 being absent from stomach. | Claudin 18 protein (isoform 18.2 in gastric epithelium) | At least 75% of tumour cells with moderate-to-strong membranous staining (zolbetuximab, gastric and gastro-oesophageal junction adenocarcinoma) | Zolbetuximab | Gastric & gastro-oesophageal junction cancer, Oesophageal cancer | Claudin 18.2 | 2024 | Claudin 18.2 positive (≥75% moderate-strong) | FDA CDx list | ||
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay Roche Diagnostics At least 75% of viable tumour cells with membrane staining of at least 2+ intensity (mirvetuximab soravtansine, ovarian cancer) | Folate receptor alpha protein | At least 75% of viable tumour cells with membrane staining of at least 2+ intensity (mirvetuximab soravtansine, ovarian cancer) | Mirvetuximab soravtansine | Ovarian cancer | Folate receptor alpha | 2022 | Folate receptor α high (≥75% 2+/3+) | FDA CDx list | ||
VENTANA MMR RxDx Panel Roche Diagnostics Loss of nuclear expression of any mismatch-repair protein in tumour cells (dostarlimab, endometrial cancer) | MLH1, PMS2, MSH2 and MSH6 protein expression | Loss of nuclear expression of any mismatch-repair protein in tumour cells (dostarlimab, endometrial cancer) | Dostarlimab, Pembrolizumab | Endometrial cancer, Colorectal cancer | PD-1 | 2021 | MSI-high / dMMR; Lynch syndrome (germline MMR) | FDA CDx list | ||
VENTANA PD-L1 (SP142) Assay Roche Diagnostics Stains fewer tumour cells than 22C3 or 28-8 (Blueprint studies), so its results are not interchangeable with the other PD-L1 assays. | PD-L1 protein (immune-cell and tumour-cell scoring) | IC at least 5% (urothelial, historic); IC at least 1% (TNBC, indication later withdrawn); TC at least 50% or IC at least 10% (NSCLC) | Atezolizumab | Bladder & urothelial cancer, Triple-negative breast cancer, Non-small-cell lung cancer | PD-L1 | 2016 | PD-L1 CPS ≥ 10 (22C3) | FDA CDx list | ||
VENTANA PD-L1 (SP263) Assay Roche Diagnostics Concordant with 22C3 for tumour-cell scoring in the Blueprint comparison; carries companion claims for several PD-1/PD-L1 antibodies in NSCLC. | PD-L1 protein (tumour-cell scoring) | TC at least 1% (durvalumab after chemoradiotherapy, NSCLC; PACIFIC-derived) | Durvalumab, Pembrolizumab, Atezolizumab | Non-small-cell lung cancer | PD-L1 | none | PD-L1 TPS ≥ 50% (lung) | FDA CDx list | ||
Vysis ALK Break Apart FISH Probe Kit Abbott Molecular Approved alongside crizotinib in 2011, the first drug-diagnostic co-approval in lung cancer. | ALK rearrangement | At least 15% of tumour cells with split or isolated 3' signals (at least 50 cells scored) | Crizotinib, Brigatinib, Alectinib | Non-small-cell lung cancer | ALK | 2011 | ALK fusion | FDA CDx list |
Back to the biomarker matrix
Tick the biomarkers a report shows on the tumour board to see matched options; see how common each target is per cancer on the prevalence matrix.
Read the cut-off, not just the name
The same analyte gates different drugs at different thresholds (PD-L1 TPS 1% versus 50%; HER2 3+ versus low). A positive result on one assay is not a positive result on another; SP142 and 22C3 are the classic example.
Primary source
The FDA list of cleared or approved companion diagnostic devices is the reference for every FDA CDx row; cut-offs are quoted from labels and trials. Corrections welcome via suggest an edit.
PD-L1 IHC 22C3 pharmDxVENTANA PD-L1 (SP142) AssayVENTANA PD-L1 (SP263) AssayPD-L1 IHC 28-8 pharmDxHercepTestPATHWAY anti-HER2/neu (4B5)HER2 IQFISH pharmDx and INFORM HER2 Dual ISHcobas EGFR Mutation Test v2therascreen EGFR RGQ PCR Kittherascreen KRAS RGQ PCR Kitcobas 4800 BRAF V600 Mutation TestTHxID BRAF Kittherascreen BRAF V600E RGQ PCR KitVysis ALK Break Apart FISH Probe KitVENTANA ALK (D5F3) CDx AssayFoundationOne CDxFoundationOne Liquid CDxGuardant360 CDxOncomine Dx Target TestAgilent Resolution ctDx FIRSTtherascreen FGFR RGQ RT-PCR Kittherascreen PIK3CA RGQ PCR KitAbbott RealTime IDH1Abbott RealTime IDH2LeukoStrat CDx FLT3 Mutation AssayBRACAnalysis CDxmyChoice CDxFoundationFocus CDxBRCAVENTANA MMR RxDx PanelMSI by PCR (Promega MSI Analysis System and equivalents)VENTANA FOLR1 (FOLR1-2.1) RxDx AssayVENTANA CLDN18 (43-14A) RxDx AssayEGFR pharmDxPSMA PET (Ga-68 PSMA-11, F-18 piflufolastat, F-18 flotufolastat)Oncotype DX Breast Recurrence ScoreSignatera (tumour-informed ctDNA MRD)Ki-67 IHC (MIB-1)Tumour mutational burden (FoundationOne CDx and equivalents)