Indications for Use
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
| Indication | Gene | Variant | Targeted therapy |
| Colorectal Cancer (CRC) | KRAS | KRAS wild-type (absence of mutations in codons 12 and 13) | Erbitux (cetuximab), or Vectibix (panitumumab) |
| Non-Small Cell Lung Cancer (NSCLC) | EGFR | Exon 19 in Frame Deletions and Exon 21 L858R Substitution Mutations | EGFR Tyrosine Kinase Inhibitors approved by FDA* |
Resources
| Use Guide | PiVAT Use Guide | Sample Sheet | SDS | Physician Insert |
