8
CDx Approved
ALK
BRAF
EGFR mutations & deletions
EGFR insertions
IDH1
RET fusions
RET mutations
ROS1
Our mission is to advance precision medicine through democratizing NGS globally to enable testing locally, closer to cancer patients.
Most innovative NGS technology to deliver fast, automated NGS results from
small samples.
Unparalleled track record and capability of partnering with pharma companies on companion diagnostics from development through regulatory approval, to bring new therapies
to patients.
The only globally distributed NGS CDx solution, commercially available and reimbursed by government and private payors in US, EU, Asia, and Middle East, accelerating patient access to new therapy 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 first approved in 2017 and and is still the only commercially distributable multiple biomarker CDx test based on NGS, which can be implemented in new laboratories around the world. Oncomine Dx Express Test is currently under development for future regulatory submissions.
Oncomine Dx Target Test* (Approved) | Oncomine Dx Express Test† (In Development) | |
Sample Type | FFPE | FFPE, plasma |
Number of Genes | 46 (EU & Japan), 23 (US and Korea) | 46 |
Alteration Types | Mutations, copy number variants, fusions | Mutations, copy number variants, fusions |
Instrument | PGM Dx | Genexus Dx - In development |
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 | |
RET | pralsetinib | |
ROS1 | crizotinib | |
Cholangiocarcinoma | IDH1 | ivosidenib |
Cancer Type | Gene | Targeted Therapies |
Non Small Cell Lung Cancer (NSCLC) | ALK | alectinib, crizotinib |
BRAF | dabrafenib in combination with trametinib | |
EGFR variants | afatinib, gefitinib, erlotinib, osimertinib |
|
RET | selpercatinib | |
ROS1 | crizotinib, entrectinib |
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 |
Cancer Type | Gene | Targeted Therapies |
Non Small Cell Lung Cancer (NSCLC) | BRAF | dabrafenib in combination with trametinib |
EGFR L858R, exon 19 deletions | gefitinib | |
ROS1 | crizotinib |
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
IDH1
RET fusions
RET mutations
ROS1
AstraZeneca
Blueprint Medicines
Chugai Pharmaceuticals
Daiichi Sankyo
Hengrui Therapeutics
Janssen Oncology
Lilly Oncology
Novartis
Pfizer
Servier Pharmaceuticals
Spectrum Pharmaceuticals
Takeda Pharmaceuticals
Austria
Belgium
Denmark
Finland
France
Germany
Italy
Israel
Japan
Korea
Netherlands
Poland
Saudi
Spain
Switzerland
United Kingdom
United States
afatinib
alectinib
amivantamab-vmjw
crizotinib
dabrafenib with trametinib
entrectinib
erlatinib
gefitinib
ivosidenib
mobocertinib
osmeritinib
pralsetinib
selpercatinib
ODxTT only available in specific countries. Contact us to learn more.
*For In Vitro Diagnostic Use.
†For investigational use only. The performance characteristics of this product have not been established.
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