EGFR mutations & deletions
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
Unparalleled track record and capability of partnering with pharma companies on companion diagnostics from development through regulatory approval, to bring new therapies
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.
A Precision Medicine Roadmap for Rx and CDx Co-development and Regulatory Approval in Japan
Our technology solves the challenges of routine biomarker testing in clinical oncology.
Oncomine Dx Target Test was first approved in 2017 and is a commercially distributable multiple biomarker CDx test based on NGS, which can be implemented in new laboratories around the world. Oncomine Dx Express Test is a CE-IVD test that enables fast NGS testing for clinically relevant biomarkers in as little as 24 hours.
|Oncomine Dx Target Test* (Approved)||Oncomine Dx Express Test (CE-IVD)**|
|Sample Type||FFPE||FFPE, plasma|
|Number of Genes||46 (EU & Japan), 23 (US and Korea)||46|
|Nucleic Acid Type||DNA and RNA||DNA, RNA, and cfTNA|
|Alteration Types||Mutations (single nucleotide variants, multi-nucleotide variants, insertions, deletions, and fusions)||Mutations, copy number variants, fusions|
|Instrument||PGM Dx||Genexus Dx Integrated Sequencer (CE-IVD)|
|Turnaround Time (Days)||
|Reimbursement Status||Reimbursed in most countries launched||In Development|
Oncomine Dx Target Test, is approved and reimbursed by government and commercial insurers in over 15 countries, covering more than 550 million lives globally.
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.