Table 4.
Companion diagnostic tests and the related concordance testing cited in the FDA Premarket Approval summaries.
| Diagnostic Test | Biomarker/ Details |
Cancer Type | Drug Name | Clinical Trial # | Compared Test | Concordance | Citations |
|---|---|---|---|---|---|---|---|
| BRACAnalysis | gBRCA1/2 | OC | Olaparib |
NCT00753545 NCT01874353 |
local testing | 99.2% (259/261) | [161] |
| BRACAnalysis | gBRCA1/2 | BC | Olaparib | NCT02000622 | BRACAnalysis | n/a | [162] |
| BRACAnalysis | gBRCA1/2 | BC | Talazoparib | NCT01945775 | BRACAnalysis | n/a | [163] |
| BRACAnalysis | gBRCA1/2 | PDAC | Olaparib | NCT02184195 | BRACAnalysis | n/a | [164] |
| BRACAnalysis | gBRCA1/2 | OC | Rucaparib | NCT01891344 | Foundation Medicine T5 |
n/a | [165,166] |
| BRACAnalysis | gBRCA1/2 | PC | Olaparib | NCT02987543 | FoundationOne CDx | n/a | [167,168] |
| FoundationOne Liquid CDx |
BRCA1/2 | OC | Rucaparib | NCT01891344 | Foundation Medicine T5 |
96.3% (209/217) | [169] |
| FoundationOne Liquid CDx |
BRCA1/2 | mCRPC | Rucaparib | NCT02952534 | FoundationOne LDT FoundationOne Liquid LDT local testing |
89.4% (144/161) | [170] |
| FoundationOne Liquid CDx | BRCA1/2 | mCRPC | Olaparib | NCT02987543 | FoundationOne CDx | n/a | [170] |
| cobas EGFR Plasma Test v2 | EGFR * | NSCLC | Erlotinib | NCT01310036 | cobas EGFR
Mutation Test v1 |
84.4% (757/897) | [171] |
| cobas EGFR Plasma Test v2 | EGFR ** | NSCLC | Osimertinib | NCT02094261 | cobas EGFR
Mutation Test v1 |
65.0% (206/317) | [172] |
| cobas EGFR Plasma Test v2 | EGFR * | NSCLC | Gefitinib | - | - | - | [173] |
| FoundationOne Liquid CDx |
EGFR * EGFR ** |
NSCLC | Erlotinib Osimertinib Gefitinib |
- | cobas EGFR
Mutation Test v2 |
94.4% (167/177) | [174] |
| Guardant360 CDx |
EGFR * EGFR ** |
NSCLC | Osimertinib | NCT02296125 | cobas EGFR
Mutation Test v2 |
79.5% (372/468) | [175] |
| Guardant360 CDx | KRAS G12C | NSCLC | Sotorasib | NCT03600883 | therascreen KRAS RGQ PCR Kit | 82.0% (155/189) | [176,177] |
| Resolution ctDx | KRAS G12C | NSCLC | Adagrasib | NCT03785249 | local testing | 95.1% (212/223) | [178] |
gBRCA1/2 = germline BRCA variants detected from DNA extracted from non-tumor cells. EGFR * = EGFR exon 19 deletions and exon 21 L858R; EGFR ** = EGFR T790M. Abbreviations: OC: ovarian cancer; BC: breast cancer; PDAC: pancreatic ductal adenocarcinoma; PC: prostate cancer; mCRPC: metastatic castration resistant prostate cancer; NSCLC: non-small cell lung cancer.