Table 3 Individual Test Performance: Test-Concordance Metrics

Antibody (developer): 22C3 (Dako) Roach et al. (2016) [Trial name: KEYNOTE-001] [5]

Indication: NSCLC

Drug against which the study validated the test: pembrolizumab

ANA: 92.6% (87.8%–96.7%)

APA: 92.8% (88.1%–96.8%)

OA: 92.7% (88.1–96.8%)

ANA: 96.4% (94.0%–98.5%)

APA: 96.5% (94.3%–98.6%)

OA: 96.4% (94.3%–98.6%)

ANA: 90.3% (84.4%–95.2%)

APA: 85.2% (75.6%–92.9%)

OA: 88.3% (81.4%–94.3%)

ANA: 91.9% (88.8%–94.8%)

APA: 87.6% (82.5%–92.2%)

OA: 90.2% (86.3%–93.7%)

Antibody (developer): 28–8 (Dako)

Phillips et al. (2015) [10]

Indication: NSCLC

Drug against which the study validated the test: nivolumab

1% Cutoff

ANA: 96.1% (94.7%–97.4%)

APA: 96.5% (95.2%–97.7%)

OA: 96.3% (94.9%–97.5%)

5% Cutoff

ANA: 91.3% (89.2%–93.2%)

APA: 89.3% (86.8%–91.6%)

OA: 90.4% (88.3%–92.3%)

1% Cutoff

ANA: 97.7% (95.6%–99.3%)

APA: 97.9% (96.0%–99.3%)

OA: 97.8% (95.9%–99.3%)

5% Cutoff

ANA: 98.7% (97.2%–99.7%)

APA: 98.3% (96.5%–99.6%)

OA: 98.5% (97.0%–99.6%)

1% Cutoff

ANA: 93.9% (92.4%–95.3%)

APA: 95.5% (94.4%–96.5%)

OA: 94.8% (93.6%–95.9%)

5% Cutoff

ANA: 90.2% (88.5%–91.8%)

APA: 90.2% (88.5%–91.8%)

OA: 90.2% (88.6%–91.8%)

1% Cutoff

ANA: 97.0% (95.2%–98.4%)

APA: 97.7% (96.5%–98.9%)

OA: 97.4% (95.9%–98.7%)

5% Cutoff

ANA: 94.8% (92.8%–96.7%)

APA: 94.8% (92.8%–96.7%)

OA: 94.8% (92.8%–96.7%)

Antibody (developer): SP263 (Roche)

Rebelatto et al. (2016) [14]

Indication: NSCLC

Drug against which the study validated the test: durvalumab

APA: 96.6% (93.8%–98.8%)

ANA: 96.8% (93.9%–98.9%)

OPA: 96.7% (94.2%–98.9%)

APA: 96.2% (92.7%–98.8%)

ANA: 96.4% (93.0%–98.8%)

OPA: 96.3% (93.3%–98.8%)

PPA: 93.3% (89.0%–95.9%)

NPA: 79.5% (73.6%–84.4%)

OPA: 86.4% (82.7%–89.3%)

NR

Antibody (developer): SP142 (Roche)

Boyd et al. (2015) [3]

Indication: NSCLC

Drug against which the study validated the test: atezolizumab

Met predefined acceptance criteria including > 90% inter-reader concordance.

NR

NR

NR

Antibody (developer): E1L3N (CST^a)

Gainor et al. 2016 [21]

Indication: NSCLC (EGFR-mutant and ALK-positive)

Drug against which the study validated the test: PD-1/PD-L1 inhibitors

Concordance between the two pathologists:

1%: 0.88 (κ = 0.75)

5%: 0.92 (κ = 0.80)

50%: 0.97 (κ = 0.89)

NR

NR

NR

Antibody (developer): E1L3N (CST^a)

Inamura et al. (2016) [23]

Indication: lung (adenocarcinoma, surgically resected)

Drug against which the study validated the test: N/A

Agreement between two pathologists: 5%: κ = 0.70 (95% CI 0.55–0.86), indicating substantial agreement

NR

NR

NR

Antibody (developer): E1L3N (CST^a)

Huynh et al. (2016) [22]

Indication: lung (adenocarcinoma, surgically resected)

Drug against which the study validated the test: N/A

Agreement between two pathologists:

1%: 0.84 (κ = 0.69)

5%: 0.91 (κ = 0.81)

50%: 0.91 (κ = 0.78)

NR

NR

NR