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.
| Device | Oncomine Dx Target Test |
| Classification Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | LIFE TECHNOLOGIES CORPORATION |
| Date Received | 2016-10-17 |
| Decision Date | 2017-06-22 |
| Notice Date | 2017-06-23 |
| PMA | P160045 |
| Supplement | S |
| Product Code | PQP |
| Docket Number | 17M-3928 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LIFE TECHNOLOGIES CORPORATION 5781 Van Allen Way carlsbad, CA 92008 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160045 | | Original Filing |
| S038 |
2022-08-05 |
Normal 180 Day Track No User Fee |
| S037 |
2022-06-14 |
Real-time Process |
| S036 |
2022-03-29 |
135 Review Track For 30-day Notice |
| S035 |
2022-03-08 |
Panel Track |
| S034 |
2021-12-23 |
Normal 180 Day Track No User Fee |
| S033 | | |
| S032 | | |
| S031 | | |
| S030 |
2021-05-14 |
30-day Notice |
| S029 | | |
| S028 | | |
| S027 | | |
| S026 | | |
| S025 | | |
| S024 |
2020-11-06 |
30-day Notice |
| S023 |
2020-10-01 |
30-day Notice |
| S022 |
2020-09-11 |
30-day Notice |
| S021 | | |
| S020 |
2020-05-14 |
30-day Notice |
| S019 | | |
| S018 |
2019-10-16 |
30-day Notice |
| S017 | | |
| S016 |
2019-07-22 |
30-day Notice |
| S015 |
2019-04-23 |
30-day Notice |
| S014 |
2019-01-31 |
30-day Notice |
| S013 |
2019-01-25 |
30-day Notice |
| S012 |
2018-11-13 |
30-day Notice |
| S011 |
2018-10-19 |
30-day Notice |
| S010 |
2018-10-09 |
30-day Notice |
| S009 | | |
| S008 |
2018-07-20 |
30-day Notice |
| S007 | | |
| S006 |
2018-05-02 |
30-day Notice |
| S005 |
2018-03-22 |
Normal 180 Day Track No User Fee |
| S004 | | |
| S003 |
2017-11-20 |
30-day Notice |
| S002 |
2017-11-08 |
30-day Notice |
| S001 |
2017-07-28 |
30-day Notice |
NIH GUDID Devices