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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.
DeviceOncomine Dx Target Test
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
5781 van allen way
carlsbad, CA 92008
PMA NumberP160045
Date Received10/17/2016
Decision Date06/22/2017
Product Code PQP 
Docket Number 17M-3928
Notice Date 06/23/2017
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel-sequencing technology to detect single nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.Table 1. List of variants for therapeutic useGene Variant Targeted therapyBRAF BRAF V600E TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib)ROS1 ROS1 fusions XALKORI® (crizotinib)EGFR L858R, Exon 19 deletions IRESSA® (gefitinib)Safe and effective use has not been established for selecting therapies using this device for the variants in Table 1 in tissue types other than NSCLC.Results other than those listed in Table 1 are indicated for use only in patients who have already been considered for all appropriate therapies (including those listed in Table 1). Analytical performance using NSCLC specimens has been established for the variants listed in Table 2.Table 2. List of variants with established analytical performance onlyGene Variant ID Nucleotide changeKRAS COSM512 c.34_35delGGinsTTKRAS COSM516 c.34G>TMET COSM707 c.3029C>TPIK3CA COSM754 c.1035T>AThe test is not indicated to be used for standalone diagnostic purposes, screening, monitoring, risk assessment, or prognosis.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Supplements:  S037 S038 S034 S031 S001 S002 S003 S005 S006 S008 S010 
S011 S012 S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 
S024 S027 S028 S029 S030 S035 S036