ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
FDA premarket approval P200011 · decided 2021-07-30
Approval details
- PMA number
- P200011
- Trade name
- 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
- Days to decision
- 528 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Natick, MA
- Statement
- Approval of the ONCO/RevealTM Dx Lung and Colon Cancer Assay (O/RDx-LCCA). The device 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
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