Oncomine Dx Express Test
FDA premarket approval P240040 · decided 2025-07-02
Approval details
- PMA number
- P240040
- Trade name
- Oncomine Dx Express Test
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Life Technologies Corporation
- Date received
- 2024-11-12
- Decision date
- 2025-07-02
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Frederick, MD
- Statement
- Approval for the Oncomine Dx Express Test. The test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology to detect substitutions, insertions, and deletions in 42 genes from DNA, copy number variants (CNVs) in 10 genes from DNA, and fusions or splice variants in 18 genes from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor samples, using the Genexus Dx Integrated Sequencer. The test is intended to be used as a companion diagnos
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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 |