The oncoReveal™ 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.
Table 1: List of Somatic Variants for Therapeutic Use
(absence of mutations
in codons 12 and 13)
|Erbitux (cetuximab), or|
|EGFR||Exon 19 in Frame Deletions and Exon 21 L858R Substitution Mutations||EGFR Tyrosine Kinase Inhibitors approved by FDA*|
|Use Guide||PiVAT Use Guide||Sample Sheet||SDS|