10
CDx Approved
ALK
BRAF
EGFR mutations & deletions
EGFR insertions
ERBB2 (HER2) activating mutations
IDH1
MET exon 14 skip
ROS1
RET fusions
RET mutations
Our vision is to democratize NGS globally and bring genomic testing closer to patients.
Our highly automated and end-to-end solutions enable a broad spectrum of laboratories to provide genomic profiling with rapid turnaround time, bringing precision oncology to more patients everywhere.
Innovative NGS technology combines speed and automation to empower more labs to conduct testing, even with small and challenging samples.
Exceptional track record and capability of CDx co-development through regulatory approval and commercialization, providing more patients to access therapies.
Globally distributed NGS CDx solution: commercially available and reimbursed by government and private payors in the US, EU, Asia, and the Middle East, accelerating patient access to new therapies through local testing.
Latest Companion Diagnostic News Global Approvals & Commercialization
Our technology solves the challenges of routine biomarker testing in clinical oncology.
Oncomine Dx Target Test was the first distributable NGS-based CDx test approved in 2017.
It is now commercially available as a distributable test, which can be implemented in laboratories around the world.
Oncomine Dx Express Test is a CE-IVD test that enables rapid NGS testing for clinically relevant biomarkers, delivering results in as little as 24 hours.
Oncomine Dx Target Test* | Oncomine Dx Express Test (CE-IVD)** | |
Sample Type | FFPE | FFPE, plasma |
Number of Genes | 46 (EU & Japan), 23 (US) | 46 |
Nucleic Acid Type | DNA and RNA | DNA, RNA, and cfTNA |
Alteration Types | Mutations and fusions | Mutations, copy number variants, fusions |
Instrument | PGM Dx | Genexus Dx Integrated Sequencer (CE-IVD) |
Workflow | Manual | Automated |
Turnaround Time (Days) |
4 |
1 |
Reimbursement Status | Reimbursed in most countries launched | In Development |
Cancer Type | Gene | Targeted Therapies |
Non Small Cell Lung Cancer (NSCLC) | BRAF | dabrafenib in combination with trametinib |
EGFR L858R, exon 19 deletions | gefitinib | |
EGFR exon 20 insertions | mobocertinib, amivantamab-vmjw | |
HER2 (ERBB2) activating mutations | fam-trastuzumab deruxtecan-nxki | |
RET | pralsetinib, selpercatinib | |
ROS1 | crizotinib | |
Cholangiocarcinoma | IDH1 | ivosidenib |
Medullary Thyroid Cancer | RET mutations (SNV, MNVs, and deletions) | selpercatinib |
Thyroid Cancer | RET fusions | selpercatinib |
Cancer Type | Gene | Targeted Therapies |
Non Small Cell Lung Cancer (NSCLC) | ALK | brigatinib, lorlatinib, alectinib, crizotinib |
BRAF | encorafenib and binimetinib | |
EGFR mutations | afatinib, gefitinib, erlotinib, osimertinib, dacomitinib |
|
RET | selpercatinib | |
ROS1 | crizotinib, entrectinib | |
HER2 | trastuzumab deruxtecan | |
Thyroid Cancer | RET fusions and mutations | selpercatinib |
BRAF | encorafenib in combination with binimetinib |
Cancer Type | Gene | Targeted Therapies |
Non Small Cell Lung Cancer (NSCLC) | ALK | Legally marketed ALK kinase inhibitors |
BRAF | Legally marketed BRAF kinase inhibitors | |
EGFR L858R, exon 19 deletions | Legally marketed EGFR tyrosine kinase inhibitors | |
ROS1 | Legally marketed ROS1 tyrosine kinase inhibitors |
Oncomine Dx Target Test, is approved and reimbursed by government and commercial insurers in over 15 countries, covering more than 550 million lives globally.
ALK
BRAF
EGFR mutations & deletions
EGFR insertions
ERBB2 (HER2) activating mutations
IDH1
MET exon 14 skip
ROS1
RET fusions
RET mutations
AstraZeneca
Bayer
Blueprint Medicines
Boehringer Ingelheim
Chugai Pharmaceuticals
Daiichi Sankyo
Hengrui Therapeutics
Janssen Oncology
Lilly Oncology
Novartis
Pfizer
Servier
Pharmaceuticals
Spectrum
Pharmaceuticals
Takeda
Pharmaceuticals
Austria
Australia
Belgium
Canada
Denmark
Finland
France
Germany
Italy
Israel
Japan
Korea
Netherlands
Poland
Spain
Saudi
Switzerland
United Kingdom
United States
afatinib
alectinib
amivantamab-vmjw
brigatinib
capmatinib
crizotinib
dabrafenib with trametinib
dacomitinib
entrectinib
encorafenib
erlotinib
fam-trastuzumab-deruxtecan-nxki
gefitinib
ivosidenib
lorlatinib
mobocertinib
osimertinib
pralsetinib
selpercatinib
tepotinib
Not all therapies are approved in all regions. Please refer to the intended use per country for details.
*For In Vitro Diagnostic Use.
** For In Vitro Diagnostic Use. Not available in all countries including the United States.
Abbreviated Intended Use: 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 (SNVs), insertions, and deletions in 23 genes from DNA and fusions in ROS1 and RET from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non–small cell lung cancer (NSCLC), IDH1 R132 mutations from FFPE tumor tissue samples from patients with cholangiocarcinoma (CC) and RET SNVs, MNVs, and deletions from DNA isolated from FFPE tumor tissue samples from patients with medullary thyroid cancer (MTC), and RET fusions from RNA isolated from FFPE tumor tissue samples from patients with thyroid cancer (TC) using the Ion PGM Dx System.
Abbreviated Intended Use: The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology and the Ion Torrent Genexus Dx System to detect deletions, insertions, substitutions, and copy number gain present in 42 genes and fusions in 18 genes from DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. The Oncomine Dx Express Test also detects deletions, insertions and substitutions in 42 genes and fusions in 7 genes from cfTNA extracted from plasma samples. The Oncomine Dx Express Test is intended to provide clinically relevant tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines as an aid in therapy management of cancer patients with solid malignant neoplasms using FFPE samples and as an aid in therapy management of cancer patients with non-small cell lung cancer using plasma samples. It is not conclusive or prescriptive for labeled use of any specific therapeutic product.
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