LUNG CANCER
CAT.# FP-002: HUMAN ALK GENE FUSION DETECTION PROBE
IVD/RUO
BACKGROUND
ALK gene encodes a transmembrane receptor tyrosine kinase (RTK). The ALK-NPM1 fusion protein was first discovered in anaplastic large cell lymphoma (ALCL). It has been found to mutate, amplify or rearrange in other tumors, including neuroblastoma and non-small cell lung cancer. Chromosome rearrangement is the most common cause of ALK and other genes. Fusion, including ALK/EML4, ALK/RANBP2, ALK/ATIC, ALK/TFG, ALK/NPM1, ALK/SQSTM1, ALK/KIF5B, ALK/CLTC, ALK/TPM4 and ALK/MSN.
PROBE DESCRIPTION
ALK gene transmembrane receptor tyrosine kinase (RTK). The ALK-NPM1 fusion protein was first discovered in anaplastic large cell lymphoma (ALCL). It has been found to mutate, amplify or rearrange in other tumors, including neuroblastoma and non-small cell lung cancer. Chromosome rearrangement is the most common cause of ALK and other genes. Fusion, including ALK/EML4, ALK/RANBP2, ALK/ATIC, ALK/TFG, ALK/NPM1, ALK/SQSTM1, ALK/KIF5B, ALK/CLTC, ALK/TPM4 and ALK/MSN.
CLINICAL SIGNIFICANCE
According to the 2013 edition of the Chinese consensus of diagnostic experts on anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer, the positive rate of ALK gene is as high as 30%-42% in NSCLC patients with adenocarcinoma, young (< 60 years old), non-smoking and no mutation in EGFR, KRAS, HER2 or P53 genes. Pathological studies suggest that the positive rate of mucinous or solid adenocarcinomas with signet ring cells is higher than that of other types of lung adenocarcinomas.
In 2013, CFDA approved XALKORI (Crizotinib) for targeted therapy of advanced ALK-positive non-small cell lung cancer, and the necessary condition for XALKORI (Crizotinib) drug therapy is FISH for ALK-positive non-small cell lung cancer. Patients with positive ALK gene fusion are sensitive to XALKORI (Crizotinib).
References
- Rodig SJ, et al. (2009) Clin Cancer Res 15: 5216-23.
- Sasaki T, et al. (2010) Eur J Cancer 46: 1773-80.
- Von Laffert M, et al. (2013) Lung Cancer 81: 200-6