Table 5.

Non-–small cell lung cancer biomarker testing methods, algorithms, and protocols (EGFR, ALK, KRAS)

Characteristic, n = 55	No. (%)
Methods* and multimethod algorithms†
EGFR, activation mutation status	55 (100)
PCR	24 (44)
Sequencing	16 (29)
IHC	2 (4)
Method not specified, use external lab	13 (24)
EGFR, gene amplification	25 (45)
FISH	8 (32)
Next generation sequencing	2 (8)
Method not specified, use external lab	15 (60)
ALK	55 (100)
FISH	32 (58)
PCR	3 (6)
PCR and FISH	1 (2)
IHC	1 (2)
IHC and FISH	1 (2)
IHC and PCR	1 (2)
IHC, PCR, and FISH	1 (2)
Method not specified, use external lab	11 (20)
Method not specified, use internally developed test	4 (7)
KRAS	53 (96)
Pyrosequencing	14 (26)
RT-PCR	11 (21)
Full sequencing	10 (19)
method not specified, conduct internally developed test	10 (19)
method not specified, use external lab	8 (15)
Multibiomarker protocols‡
Sequence is based on oncologist order	24 (43.5)
Run all biomarker tests upfront	19 (34.5)
Run biomarkers sequentially	12 (22)
Run KRAS, if negative, run EGFR, if negative, run ALK	3 (25)
Run KRAS and EGFR upfront; if both negative, run ALK	3 (25)
Run EGFR, if negative, ALK (KRAS not used or not routinely used)	3 (25)
Run EGFR, if negative, run KRAS and ALK	2 (17)
Run EGFR and ALK simultaneously, if negative, run KRAS	1 (8)

* Method, type of technology for testing a biomarker. Italicized choices represent various technologic methods used for determining specific biomarker status. ALK = anaplastic lymphoma kinase; EGFR = epidermal growth factor receptor; FISH = fluorescence in situ hybridization; IHC = Immunohistochemistry; KRAS = v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; PCR = polymerase chain reaction; RT-PCR = reverse transcription polymerase chain reaction.

^† Multimethod algorithm, a sequence of methods for testing one biomarker, when multiple methods are used.

^‡ Multibiomarker protocol, a sequence of testing multiple biomarkers.