The ONCO/RevealTM Dx Lung and Colon Cancer Assay (O/RDx-LCCA) is a qualitative next generation sequencing based in vitro diagnostic test that uses amplicon-based target enrichment technology for detection of single nucleotide variants (SNVs) and deletions in two genes from DNA isolated from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients with NSCLC or CRC who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling. The O/RDx-LCCA is intended to be used on the Illumina MiSeqDx® instrument.
Colorectal Cancer, Non Small Cell Lung Cancer
EGFR (Epidermal growth factor receptor), KRAS (KRAS proto-oncogene GTPase)
Erbitux (cetuximab), Gilotrif (afatinib), Vectibix (panitumumab), Vizimpro (dacomitinib), erlotinib, gefitinib
Next-Generation Sequencing (NGS)