Table 6.
Location of testing and the use of internally developed test vs commercial test
| Characteristic* | Sites using test method | Internal testing with internally developed test | Internal testing with commercial test kit or reagent | Sent to external/ outside lab |
|---|---|---|---|---|
| No. (%) | No. (%) | No. (%) | No. (%) | |
| Breast cancer (n = 57) | ||||
| HER2 IHC | 46 (80%) | 3 (5%) | 43 (75%) | 0 |
| HER2 FISH | 52 (91%) | 3 (5%) | 43 (75%) | 6 (10%) |
| HER2 CISH | 3 (5%) | 1 (2%) | 2 (3%) | 0 |
| HER2 SISH | 3 (5%) | 0 | 3 (5%) | 0 |
| ER IHC | 57 (100%) | 6 (10%) | 50 (88%) | 1 (2%) |
| ER LBA | 3 (5%) | 1 (2%) | 2 (3%) | 0 |
| ER RT-PCR | 5 (9%) | 0 | 0 | 5 (9%) |
| PgR IHC | 57 (100%) | 7 (12%) | 50 (88%) | 0 |
| PgR LBA | 2 (4%) | 1 (2%) | 0 | 1 (2%) |
| PgR RT-PCR | 4 (7%) | 0 | 0 | 4 (7%) |
| Gastric/Esophageal cancer (n = 54) | ||||
| HER2 IHC | 45 (84%) | 8 (15%) | 36 (67%) | 1 (2%) |
| HER2 FISH | 51 (94%) | 10 (18%) | 34 (63%) | 7 (13%) |
| HER2 CISH | 2 (4%) | 1 (2%) | 1 (2%) | 0 |
| HER2 SISH | 2 (4%) | 0 | 2 (4%) | 0 |
| Non–small cell lung cancer (n = 55) | ||||
| EGFR activation mutation status - PCR | 24 (44%) | 13 (24%) | 5 (9%) | 6 (11%) |
| EGFR activation mutation status - Sequencing | 16 (29%) | 12 (22%) | 1 (2%) | 3 (5%) |
| EGFR activation mutation status - IHC | 2 (4%) | 2 (4%) | 0 | 0 |
| EGFR activation mutation status - method not specified | 13 (24%) | 2 (4%) | 0 | 11 (20%) |
| EGFR, gene amplification - FISH | 8 (15%) | 6 (11%) | 2 (3.5%) | 0 |
| EGFR, gene amplification - Next Gen Seq | 2 (4%) | 2 (4%) | 0 | 0 |
| EGFR, gene amplification - method not specified | 15 (27%) | 0 | 0 | 15 (27%) |
| ALK FISH | 35 (64%) | 18 (33%) | 10 (18%) | 7 (13%) |
| ALK PCR | 6 (11%) | 3 (5.5%) | 0 | 3 (5.5%) |
| ALK IHC | 4 (7%) | 4 (7%) | 0 | 0 |
| ALK method not specified | 15 (27%) | 4 (7%) | 0 | 11 (20%) |
| KRAS full sequencing | 10 (18%) | 9 (16%) | 0 | 1 (2%) |
| KRAS pyrosequencing | 14 (25.5%) | 11 (20%) | 3 (5.5%) | 0 |
| KRAS PCR | 11 (20%) | 5 (9%) | 2 (4%) | 4 (7%) |
| KRAS method not specified | 18 (33%) | 8 (14.5%) | 2 (4%) | 8 (14.5%) |
* Some institutions use two or more methods. ALK = anaplastic lymphoma kinase; CISH = chromogenic in situ hybridization; EGFR = epidermal growth factor receptor; ER = estrogen receptor; FISH = fluorescence in situ hybridization; HER2 = human epidermal growth factor receptor 2; IHC = immunohistochemistry; KRAS = v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; LBA = ligand-binding assay; PCR = polymerase chain reaction; PgR = progesterone receptor; RT-PCR = reverse transcription polymerase chain reaction; SISH = silver in situ hybridization.