Oncomine Dx Target Test
FDA premarket approval P160045/S050 · decided 2025-11-19
Approval details
- PMA number
- P160045
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Oncomine Dx Target Test
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Life Technologies Corporation
- Date received
- 2025-04-22
- Decision date
- 2025-11-19
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Carlsbad, CA
- Statement
- Approval to include a companion diagnostic indication for the detection of ERBB2/HER2 activating mutations (SNVs in exons 18-21 within the tyrosine kinase domain and exon 20 insertions) in patients with non-small cell lung cancer who may benefit from treatment with HYRNUO® (sevabertinib).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (K241806) | Life Technologies Corporation | 2025-01-08 |
| Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (K233453) | Life Technologies Corporation | 2024-07-10 |
| Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (K191030) | Life Technologies Corporation | 2020-02-21 |
| Ion PGM Dx System (K170299) | Life Technologies Corporation | 2017-06-22 |
| QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (K123955) | Life Technologies Corporation | 2013-03-08 |
| STEMPRO MSC SFM (K103302) | Life Technologies Corporation | 2011-02-18 |
| KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616) | Life Technologies Corporation | 2010-05-20 |