AMDL’s platform is helping health systems and research institutions accelerate the integration of genomics into clinical care.
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ONCO/Reveal™ Dx Lung and Colon Cancer Assay
The ONCO/RevealTM Dx Lung and Colon Cancer Assay (oRDX-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 2 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 therapeutics listed in Table 1 in accordance with the approved therapeutic product labeling. The oRDX-LCCA is intended to be used on the Illumina MiSeqDx® instrument.