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 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 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 useindication gene variant targeted therapycolorectal cancer (crc) kras kras wild-type (absence of mutations in codons 12 and 13) erbitux® (cetuximab), orvectibix® (panitumumab)non-small cell lung cancer(nsclc) egfr exon 19 deletions and exon 21 l858r substitution mutations egfr tyrosine kinase inhibitors approved by fda**for the most current information about the therapeutic products in this group, go to: https://www. Fda. Gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431. Htm
| Device | ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Pillar Biosciences |
| Date Received | 2020-02-18 |
| Decision Date | 2021-07-30 |
| PMA | P200011 |
| Supplement | S |
| Product Code | PQP |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Pillar Biosciences 9 Strathmore Road natick, MA 01760 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200011 | Original Filing |