Premarket Approval (PMA)

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.

• Device: Oncomine Dx Target Test
• Generic Name: Next generation sequencing oncology panel, somatic or germline variant detection system
• Applicant: LIFE TECHNOLOGIES CORPORATION; 5781 VAN ALLEN WAY; CARLSBAD, CA 92008
• PMA Number: P160045
• Date Received: 10/17/2016
• Decision Date: 06/22/2017
• Product Code: PQP
• Docket Number: 17M-3928
• Notice Date: 06/23/2017
• Advisory Committee: Pathology
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S001 S002 S003 S005 S006 S008 S010 S011 S012 S013 S014 ; S015 S016 S018 S019 S020 S021 S022 S023 S024 S025 S027 S028 ; S029 S030 S031 S034 S035 S036 S037 S038 S040 S041 S042 S043 ; S044