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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantPillar Biosciences
9 Strathmore Road
Natick, MA 01760
PMA NumberP200011
Date Received02/18/2020
Decision Date07/30/2021
Product Code PQP 
Docket Number 21M-0853
Notice Date 08/03/2021
Advisory Committee
Expedited Review Granted? No
Combination ProductNo
Approval Order 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 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
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
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