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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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:  S001 
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