Oncomine Solid Tumour Kits

The Oncomine Solid Tumour kits are CE-IVD* next-generation sequencing (NGS) kits for both DNA and RNA workflows enabling analysis of solid tumour formalin-fixed and paraffin-embedded (FFPE) samples. They enable accurate and reliable results for both DNA and RNA analyses starting from as little as 10 ng of nucleic acid.  With content coverage designed with leading clinicians from the OncoNetwork Consortium,** these kits enable the assessment of actionable mutations involved in solid tumors, particularly those originating from the lung and colon***.

Compared to other molecular diagnostic testing methods, NGS offers higher multiplex capacity and wider target coverage from FFPE samples while maintaining the quality of performance and confidence needed for the clinical laboratory. Traditional molecular diagnostic kits involve single-gene tests performed in succession to determine the presence or absence of variants of interest.  

With the Oncomine Solid Tumour DNA and Oncomine Solid Tumour Fusion Transcript kits:

• You will be able to analyze your sample for multiple variants of interest using a single FFPE sample in a single experiment.
  
• You can detect single nucleotide changes, inversions, insertions, deletions, and multiple gene fusions in a single run.
• You only need as little as 10 ng of FFPE DNA or RNA, enabling analysis of samples that may contain partially degraded or limited tumour material,
  
• A simple workflow enables you to produce targeted libraries, typically in 3.5 hours.

The Oncomine Solid Tumour DNA Kit consists of a single pool of primers and associated reagents to perform multiplex PCR for preparation of amplicon libraries for NGS, providing sensitive and comprehensive sample amplification. Sufficient reagents are supplied for 96 tests, together with bar codes to facilitate the combination of up to 16 samples in a single NGS run.

The Oncomine™ Solid Tumour Fusion Transcript Kit consists of a single pool of primers and associated reagents to perform multiplex PCR for preparation of amplicon libraries for NGS, enabling sensitive and comprehensive sample amplification. Sufficient reagents are supplied for 96 tests, together with bar codes to facilitate the combination of up to 16 samples in a single NGS run. The kit includes Optimized positive controls designed to distinguish an assay failure from a true negative sample

*According to Directive 98/79/EC on in vitro diagnostics. Available in Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Finland, Hungary, Iceland, Ireland, Italy, Germany, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Not available in the US.

**OncoNetwork members:

• Dr. José Luis Costa, PhD, IPATIMUP Medical Faculty of Porto University, Portugal
• Prof. Ian Cree, Warwick Medical School, United Kingdom
• Prof. Harriet Feilotter, Queen's University, Ontario, Canada
• Dr. Henriette Kurth, Viollier AG Basel, Switzerland
• Dr. Marjolijn J.L. Ligtenberg, Radboud University Medicial Center, Nijmegen, Netherlands
• Prof. Jose Carlos Machado, IPATIMUP Medical Faculty of Porto University, Portugal
• Prof. Kazuto Nishio, Faculty of Medicine, Kinki University Osaka, Japan
• Dr. Cristoph Noppen, Viollier AG Basel, Switzerland
• Dr. Nicola Normanno, Centro Ricerche Oncologiche Mercogliano, Italy
• Prof. Pierre Laurent Puig, Université Paris Descartes, Paris, France
• Prof. Aldo Scarpa, ARC-NET University of Verona, Italy
• Prof. Orla Sheils, Trinity College, Dublin, Ireland
• Dr. Bastiaan Tops, Radboud University Medical Center, Nijmegen, Netherlands
• Prof. Cecily P. Vaughn, ARUP- Institute for Clinical and Experimental Pathology, Utah, USA

***Intended use statements:
The Oncomine Solid Tumour DNA Kit provides material that captures regions of human somatic variants (deletions, insertions, inversions, and substitutions) present in selected regions in the following cancer related genes: EGFR, ALK,  ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, MET, DDR2, KRAS, PIK3CA, BRAF, AKT1, PTEN, NRAS, MAP2K1, STK11, NOTCH1, CTNNB1, SMAD4, FBXW7, TP53 for analysis using next generation sequencing technology. The Solid Tumour DNA Panel is intended for in vitro diagnostic use by trained personnel in a professional laboratory environment with extracted human DNA samples including those from formalin-fixed paraffin-embedded (FFPE) tissues.

The Oncomine Solid Tumour Fusion Transcript Kit is intended to detect rearrangements involving the ALK gene and specific rearrangements for ROS-1, RET and NTRK-1 genes analysis using next generation sequencing technology. This kit is intended for in vitro diagnostic use by trained personnel in a professional laboratory environment with extracted human RNA samples including those from formalin-fixed paraffin-embedded (FFPE) tissues.