PQP · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
· Class 3
Overview
| Product Code | PQP |
|---|---|
| Device Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Device Class | Class 3 |
| Review Panel |
Identification
A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250027 | Guardant360® Liquid CDx | Guardant Health, Inc. | May 19, 2026 | APPR |
| P260004 | Signatera CDx | Natera, Inc. | May 15, 2026 | APPR |
| P240040 | Oncomine Dx Express Test | Life Technologies Corporation | Jul 2, 2025 | APPR |
| P240010 | MI Cancer Seek | Caris Life Sciences | Nov 5, 2024 | APPR |
| P230011 | TruSight Oncology Comprehensive | Illumina, Inc. | Aug 21, 2024 | APPR |
| P210011 | xT CDx | Tempus Labs, Inc. | Apr 28, 2023 | APPR |
| P210040 | RESOLUTION ctDx FIRST | Exact Sciences Corporation | Dec 12, 2022 | APWD |
| P200011 | ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) | Pillar Biosciences | Jul 30, 2021 | APPR |
| P200016 | FoundationOne Liquid CDx | Foundation Medicine, Inc. | Nov 6, 2020 | APCB |
| P200006 | FoundationOne Liquid CDx (F1 Liquid CDx) | Foundation Medicine, Inc. | Oct 26, 2020 | APCB |
| P190032 | FoundationOne Liquid CDx (F1 Liquid CDx) | Foundation Medicine, Inc. | Aug 26, 2020 | APPR |
| P200010 | Guardant360 CDx | Guardant Health, Inc. | Aug 7, 2020 | APPR |
| P170019 | FoundationOne CDx | Foundation Medicine, Inc. | Nov 30, 2017 | APPR |
| P160038 | Praxis Extended RAS Panel | Illumina, Inc. | Jun 29, 2017 | APWD |
| P160045 | Oncomine Dx Target Test | Life Technologies Corporation | Jun 22, 2017 | APPR |
| P160018 | FoundationFocus CDxBRCA | Foundation Medicine, Inc. | Dec 19, 2016 | APWD |
Top Applicants
- Foundation Medicine, Inc. — 5 clearances
- Guardant Health, Inc. — 2 clearances
- Illumina, Inc. — 2 clearances
- Life Technologies Corporation — 2 clearances
- Caris Life Sciences — 1 clearance
