# PQP · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/PQP

## Overview

- **Product Code:** PQP
- **Device Name:** Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## 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 (20 of 52)

Showing 20 most recent of 52 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240040S005](/device/P240040S005.md) | Oncomine™ Dx Express Test | Life Technologies Corporation | Sep 9, 2026 | APPR |
| [P230011S006](/device/P230011S006.md) | TruSight Oncology Comprehensive | Illumina, Inc. | Aug 14, 2026 | APPR |
| [P250036](/device/P250036.md) | PGDx elio tissue complete CDx | Personal Genome Diagnostics, Inc. | Jul 30, 2026 | APPR |
| [P190032S029](/device/P190032S029.md) | FoundationOne Liquid CDx | Foundation Medicine, Inc. | May 27, 2026 | APPR |
| [P170019S060](/device/P170019S060.md) | FoundationOne CDx (F1CDx) | Foundation Medicine, Inc. | May 27, 2026 | APPR |
| [P250027](/device/P250027.md) | Guardant360® Liquid CDx | Guardant Health, Inc. | May 19, 2026 | APPR |
| [P260004](/device/P260004.md) | Signatera™ CDx | Natera, Inc. | May 15, 2026 | APPR |
| [P200010S026](/device/P200010S026.md) | Guardant360 CDx | Guardant Health, Inc. | Jan 15, 2026 | APPR |
| [P200010S021](/device/P200010S021.md) | Guardant360 CDx | Guardant Health, Inc. | Sep 25, 2025 | APPR |
| [P240040](/device/P240040.md) | Oncomine Dx Express Test | Life Technologies Corporation | Jul 2, 2025 | APPR |
| [P170019S054](/device/P170019S054.md) | FoundationOne CDx | Foundation Medicine, Inc. | Jan 16, 2025 | APPR |
| [P240010](/device/P240010.md) | MI Cancer Seek | Caris Life Sciences | Nov 5, 2024 | APPR |
| [P160045S046](/device/P160045S046.md) | Oncomine Dx Target Test | Life Technologies Corporation | Oct 17, 2024 | APPR |
| [P230011](/device/P230011.md) | TruSight Oncology Comprehensive | Illumina, Inc. | Aug 21, 2024 | APPR |
| [P200011S001](/device/P200011S001.md) | oncoRevealTM CDx | Pillar Biosciences | Apr 18, 2024 | APPR |
| [P170019S048](/device/P170019S048.md) | FoundationOne CDx (F1CDx) | Foundation Medicine, Inc. | Nov 16, 2023 | APPR |
| [P190032S011](/device/P190032S011.md) | FoundationOne Liquid CDx (F1LCDx) | Foundation Medicine, Inc. | Oct 11, 2023 | APPR |
| [P170019S043](/device/P170019S043.md) | FoundationOne CDx (F1CDx) | Foundation Medicine, Inc. | Oct 6, 2023 | APPR |
| [P160045S025](/device/P160045S025.md) | Oncomine Dx Target Test | Life Technologies Corporation | Sep 29, 2023 | APPR |
| [P190032S010](/device/P190032S010.md) | FoundationOne Liquid CDx (F1 Liquid CDx) | Foundation Medicine, Inc. | Jun 8, 2023 | APPR |

## Top Applicants

- Foundation Medicine, Inc. — 24 clearances
- Life Technologies Corporation — 10 clearances
- Guardant Health, Inc. — 8 clearances
- Illumina, Inc. — 3 clearances
- Pillar Biosciences — 2 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/PQP](https://fda-staging.innolitics.com/productcode/PQP)

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**Cite:** Innolitics at https://innolitics.com