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- The Oncomine Dx Target Test is a laboratory test designed to detect genetic variations in tumor tissue samples from patients with non-small cell lung cancer (NSCLC), cholangiocarcinoma, and anaplastic thyroid cancer12345. It uses targeted high-throughput, parallel-sequencing technology to detect sequence variations in specific genes135. The test helps doctors identify patients who may benefit from specific FDA-approved treatments25.Learn more:✕This summary was generated using AI based on multiple online sources. To view the original source information, use the "Learn more" links.The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect sequence variations in 46 genes in DNA and RNA isolated from FFPE specimens using the Ion PGM Dx System.www.thermofisher.com/order/catalog/product/ar/en/…The Oncomine Dx Target Test is a laboratory test designed to detect the presence of mutations within a specific gene in patients who have cancer. This test helps doctors identify patients with cholangiocarcinoma who may benefit from specific FDA-approved treatments.www.fda.gov/medical-devices/recently-approved-d…The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect sequence variations in 23 genes in DNA and RNA isolated from formalin-fixed, paraffin-embedded tumor (FFPE) tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System.www.thermofisher.com/order/catalog/product/A49755The Oncomine Dx Target Test (ODxTT) is a laboratory test designed to find genetic variations in the genetic material of tumor tissue from patients with non-small cell lung cancer (NSCLC) and cholangiocarcinoma.www.fda.gov/medical-devices/recently-approved-d…The Oncomine™ Dx Target Test is a laboratory test designed to detect genetic changes in tumor tissue samples from a person with certain type of cancers. This approval expands the use of the test to identify a certain mutation in anaplastic thyroid cancer.www.fda.gov/medical-devices/recently-approved-d…
Oncomine Dx Target Test--US - Thermo Fisher Scientific
The Oncomine Dx Target Test is a next-generation sequencing (NGS) test that can detect multiple biomarkers for targeted therapies in NSCLC, cholangiocarcinoma, and thyroid cancer. It is a companion diagnostic device …
Other content from thermofisher.comThe Oncomine Dx Target Test is a next-generation sequencing (NGS) in vitro diagnostic (IVD) test for non-small cell lung cancer (NSCLC), cholangiocarcinoma (CC), and thyroid cancer …
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Oncomine™ Dx Target Test – P160045/S035 | FDA
Sep 29, 2022 · The Oncomine Dx Target Test helps doctors identify patients with non-small cell lung cancer who may be eligible to receive treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki).
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Oncomine™ Dx Target Test – P160045/S025 | FDA
Jan 26, 2024 · The Oncomine™ Dx Target Test is a laboratory test designed to detect genetic changes in tumor tissue samples from a person with certain type of cancers. This approval …
This document provides information on the Oncomine Dx Target Test, a next-generation sequencing assay for detection of cancer-related gene alterations. It covers the intended use, …
Oncomine Dx Target Test Technical and Validation …
The Oncomine Dx Target Test is a NGS in vitro diagnostic test that detects multiple biomarkers for NSCLC, CC, and TC patients. It has established concordance with FDA approved or validated methods for EGFR, BRAF, …
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The Oncomine Dx Target Test utilizes a single streamlined NGS workflow for detecting cancer-associated biomarkers, incorporating reagents, instrument systems, and bioinformatics. The …
Targeted Next-Generation Sequencing In Vitro …
The Oncomine Dx Target Test is a low-cost, fast and reimbursed NGS test for NSCLC patients. It delivers multiple biomarker results for multiple targeted therapies from one sample, with lower tissue requirements and shorter …
The Oncomine Dx Target Test is a NGS test that can detect 368 variants in 23 cancer-associated genes, including EGFR, BRAF, ROS1, and others, from one NSCLC sample. It can help select …
The Ion TorrentTM OncomineTM Dx Target Test is the fi rst CE-IVD solid-tumor biomarker test, based on targeted next-generation sequencing (NGS), which detects key biomarkers that are …
Oncomine Dx Target Test - Thermo Fisher Scientific
The Oncomine Dx Target Test is designed for use with the Ion PGM Dx System, including the instrument, reagents, and software. This system facilitates 21CFR Part 11 compliance, allowing for role-based workflows, sample and reagent …
The Ion Torrent™ Oncomine™ Dx Target Test achieves 71% success with only 1 tissue slide. As more genes are required, slide consumption when using single-gene methods continues to …
Dx Target Test (Cat. No. A49755) provides a set of primers in two panels that target key regions of 23 genes related to NSCLC and one related to CC. Intended use
The Ion Torrent ™ Oncomine Dx Target Test is the first targeted next-generation sequencing (NGS) in vitro diagnostic test for non-small cell lung cancer (NSCLC), cholangiocarcinoma …
The Ion Torrent ™ Oncomine Dx Target Test is the first FDA-approved, next-generation sequencing (NGS)-based companion diagnostic (CDx) that can help you achieve
Oncomine Dx Target Test – P160045/S028 | FDA
Oct 4, 2021 · The Oncomine Dx Target Test is a laboratory test designed to detect the presence of mutations within a specific gene in patients who have cancer. This test helps...
Oncomine™ Dx Target Test - Thermo Fisher Scientific
The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high-throughput, parallel-sequencing technology to detect sequence variations in 46 genes in DNA …
Oncomine Dx Target Test 510(k) FDA Approval
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 …
Thermo Fisher’s Oncomine Dx Target Test - The Pathologist
Dec 5, 2023 · The Oncomine Dx Express Test covers relevant genes and variants across numerous solid tumor types, including NSCLC, breast, melanoma, colorectal, and thyroid, …
Oncomine Dx Target Test—Europe - Thermo Fisher Scientific
The Oncomine Dx Target Test is the only test that detects 46 cancer driver gene variants, including EGFR mutations (including L858R, T790M, and exon 19 deletions); BRAF, KRAS, …
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