(FDA-IVD)oncoReveal™ Dx Lung and Colon Cancer Assay FDA Approved


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

IndicationGeneVariantTargeted therapy
Cancer (CRC)
KRASKRAS wild-type
(absence of mutations
in codons 12 and 13)
Erbitux (cetuximab), or
Vectibix (panitumumab)
Non-Small Cell
Lung Cancer
EGFRExon 19 in Frame Deletions and Exon 21 L858R Substitution MutationsEGFR Tyrosine Kinase Inhibitors approved by FDA*


Use GuidePiVAT Use GuideSample SheetSDSPhysician Insert