Geneclock

A new paradigm in testing for targeted therapies

In the era of personalized medicine, molecular profiling has become essential for the treatment of patients with metastatic non-small cell lung carcinoma (NSCLC).  With an increasing number of genomic alterations becoming clinically relevant, sequential testing of individual mutations becomes a significant challenge for clinical laboratories. Next-generation sequencing (NGS), which can detect multiple alterations at once from a small amount of tissue, offers a solution.

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  • Multiple therapies—one test indicated as a companion diagnostic device to aid in selecting NSCLC patients for treatment
  • Multiple biomarkers—one test for detection of 46 genes associated with targeted oncology treatments approved or in development
  • One sample—one sample used to deliver multiple biomarker results, minimizing the risk of depleting tissues and requiring additional biopsies
  • Fast results— from sample extraction to clinical test report, the total workflow turn-around time is four days
  • Established performance—concordance with comparator methods based on FISH or PCR was established for EGFR, BRAF, ALK, and ROS1

For technical and validation data information please download the brochure above.

Oncomine Dx Target Test content

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, ERBB2, and MET exon 14 skipping mutations; and ALK, ROS1, RET, and NTRK1/2/3 fusions.

Figure 2
Figure 2. Examples of genes with cancer driver variants associated with different tumor types.

Explore our new oncomine.com educational portal to learn how NGS is driving precision oncology from research to diagnostics


The power of next generation sequencing

Next-generation sequencing (NGS) can sequence hundreds to thousands of genes and detect multiple biomarkers at the same time. The sequencing takes place in a chip that contains millions of wells (flow cells) with separate sequencing reactions taking place in each well, allowing many genes to be sequenced at once and multiple variations to be detected simultaneously, unlike traditional companion diagnostic technologies such as FISH, IHC, or PCR, which only analyze one target gene at the time.

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Figure 3. The NGS process starts with extraction of the DNA and/or RNA, which is processed in the chip in the Ion PGM Dx instrument, and results are analyzed and reported by a dedicated bioinformatics solution.

For In Vitro Diagnostic Use.