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Companion Diagnostics
Your CDx partner from translational research to global commercialization
Our vision is to make NGS accessible worldwide, bringing genomic testing closer to patients. With highly automated, end-to-end solutions, we empower a wide range of laboratories to provide genomic profiling with rapid turnaround times - bringing precision oncology to more patients everywhere. With proven expertise in companion diagnostics (CDx), we bridge translational research and global commercialization, accelerating the journey from development to clinical adoption.
Why are Oncomine Solutions a trusted choice for pharma?
- 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.
Oncomine NGS technology
Our technology addresses many of the challenges with biomarker testing in clinical oncology.
- Shorter turnaround times provide clinicians with timely results for more informed treatment decisions
- Automated workflows reduce labor time and operational costs
- Low sample input requirements enables more samples to be tested successfully so more patients can get actionable results
Oncomine NGS CDx solutions
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 are IVD tests that enables rapid NGS testing for relevant biomarkers, delivering results in as little as 24 hours.
| Oncomine Dx Target Test*
| Oncomine Dx Express Test (CE-IVD)**
| Oncomine Dx Express Test (IVD)†
|
Sample type | FFPE | FFPE, plasma | FFPE |
Number of genes | 46 (EU & Japan), 23 (US) | DNA, RNA, and cfTNA | DNA and RNA |
Alteration types | Mutations and fusions | Mutations, copy number variants, fusions | Substitutions, insertions, deletions, copy number variants, fusions, splice variants |
Instrument | PGM Dx | Genexus Dx System (CE-IVD) | Genexus Dx System (IVD) |
Workflow | Manual | Automated | Automated |
Turnaround time (days) | 4 | 1 | 1 |
Reimbursement status | Reimbursed in most countries launched | Varies by country | In development |
Oncomine Dx Target Test CDx Indications
United States
| 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 | amivantamab-vmjw | |
| HER2 (ERBB2) activating mutations | fam-trastuzumab deruxtecan-nxki | |
| RET | pralsetinib, selpercatinib | |
| ROS1 | crizotinib | |
| Glioma | IHD1/2 | vorasidenib |
| Cholangiocarcinoma | IDH1 | ivosidenib |
| Medullary Thyroid Cancer | RET mutations (SNV, MNVs, and deletions) | selpercatinib |
| Thyroid Cancer | RET fusions | selpercatinib |
Europe
| 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 |
Japan
| 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 |
Companion diagnostic news
July 3, 2025
October 21, 2024
March 20, 2024
October 19, 2023
September 9, 2023
January 24,2023
Global approvals and commercialization
Oncomine Dx Target Test, is approved and reimbursed by government and commercial insurers in over 15 countries, covering more than 550 million lives globally.
*CDx indications and therapies mentioned represent global approvals. Not all indications and therapies are available in all regions or countries.
Learn more about our partnership program to commercialize CDx tests with pharmaceutical and biotech companies. In close collaboration with our pharmaceutical partners, we provide solutions to assist in all stages of CDx development from the biomarker discovery process through CDx commercialization. Our dedicated CDx co-development teams embody expertise in program management, R&D, product development, quality control, regulatory, and commercialization.
* For In Vitro Diagnostic Use.
** For In Vitro Diagnostic Use. Not available in all countries, including the United States.
† For In Vitro Diagnostic Use.
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.
Intended use: The Oncomine™ Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology to detect substitutions, insertions, and deletions in 42 genes from DNA, copy number variants (CNVs) in 10 genes from DNA, and fusions or splice variants in 18 genes from RNA isolated from formalin-fixed, paraffin-embedded(FFPE) tumor samples using the Genexus™ Dx Integrated Sequencer.
The test is intended to be used as companion diagnostic to identify patients who may benefit from treatment with the targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling.
Table 1 Companion diagnostic indications Tissue type | Gene | Variant | Targeted therapy |
Non-small cell lung cancer (NSCLC) | EGFR | EGFR exon 20 insertions | ZEGFROVY™ (sunvozertinib) |