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Solid Tumour Precision Panel (50 Genes)

The Solid Tumour Precision Panel is a targeted next-generation sequencing (NGS) test that analyses DNA and RNA from a single tumour sample. It detects hotspot mutations, small insertions and deletions, copy number variations, gene fusions and splice variants across 50 genes relevant to solid cancers.

The test uses tumour tissue already obtained at biopsy or surgery. It analyses the tumour only and does not determine whether an alteration is inherited.

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Solid Tumour Precision Panel (50 Genes)
Sample FFPE tumour block or 8 to 10 unstained sections; at least 20% tumour content preferred
Turnaround 3 working days from receipt of a suitable sample
Method Targeted amplicon NGS of DNA and RNA on the Genexus System
Clinical Area Cancer Genomics
Clinical Indications Method and Coverage Sample & Preparation Documents & Timing Limitations Results & Counselling Charges & Downloads
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Clinical Indications

  • Advanced, metastatic or recurrent solid tumours, to identify alterations that guide targeted therapy.
  • Earlier-stage solid tumours where a molecular biomarker informs treatment.
  • Progression on targeted therapy, to identify acquired resistance alterations.

Method & Coverage

Method

DNA and RNA are co-extracted from the tumour sample and analysed by targeted amplicon-based NGS on the automated Genexus System. DNA is used to detect single nucleotide variants, small insertions and deletions, and copy number variations. RNA is used to detect gene fusions and splice variants, which DNA-based assays may miss.

The assay requires as little as 10 ng of DNA or RNA, which makes it suitable for small biopsies and cytology cell blocks.

Genes Analysed

DNA hotspot mutations (SNVs and indels): 45 genes

AKT1, AKT2, AKT3, ALK, AR, ARAF, BRAF, CDK4, CDKN2A, CHEK2, CTNNB1, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GNA11, GNAQ, GNAS, HRAS, IDH1, IDH2, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, NTRK1, NTRK2, NTRK3, PDGFRA, PIK3CA, PTEN, RAF1, RET, ROS1, SMO, TP53

Copy number variations: 14 genes

ALK, AR, CD274, CDKN2A, EGFR, ERBB2, ERBB3, FGFR1, FGFR2, FGFR3, KRAS, MET, PIK3CA, PTEN

Inter-genic fusions (RNA): 16 genes

ALK, BRAF, ESR1, FGFR1, FGFR2, FGFR3, MET, NRG1, NTRK1, NTRK2, NTRK3, NUTM1, RET, ROS1, RSPO2, RSPO3

Intra-genic alterations (RNA): 3 genes

AR (AR-V7), EGFR (EGFRvIII), MET (exon 14 skipping)

Several genes are analysed for more than one type of alteration.

Sample & Preparation

  • Preferred sample: formalin-fixed paraffin-embedded (FFPE) tumour block from biopsy or resection.
  • Alternative: 8 to 10 unstained sections of 5 to 10 µm on plain glass slides, with one matching H&E-stained slide.
  • Small samples: core biopsies, small biopsies and FNA cell blocks are acceptable.
  • Tumour content: at least 20% tumour cells is preferred. The tumour area is reviewed and marked by a pathologist before testing.
  • Block age: blocks less than 3 years old give the best results.
  • Unsuitable samples: bone decalcified with strong acid, and tissue fixed in anything other than 10% neutral buffered formalin.
  • Transport: room temperature (15 to 25°C), protected from heat. No cold chain is required.

Tumour sample selection and pre-analytical review

Sample selection

  • Select the FFPE block with the highest tumour content and least necrosis.
  • A tumour content of at least 20% is preferred. Samples with lower tumour content are assessed individually.
  • For small biopsies or cytology, a cell block with adequate cellularity is acceptable.
  • Recent blocks (less than 3 years old) give the best nucleic acid quality.
  • Use tissue fixed in 10% neutral buffered formalin for 6 to 72 hours.
  • Avoid bone samples decalcified with strong acid. EDTA-decalcified samples may be acceptable.

Pre-analytical Review

A pathologist reviews the H&E slide, confirms tumour content and marks the tumour area for macrodissection where required. If a sample is unsuitable, the referring clinician is informed within 1 working day so that an alternative block can be sent.

See also general sample requirements and reasons samples may be rejected

Documents & Timing

Documents

  • Label every sample with at least two patient identifiers, matching the requisition form.
  • Include the completed requisition form, clinical information and signed consent.

Accompanying Information

  • Histopathology report with block or slide identification.
  • Clinical summary: diagnosis, stage and previous targeted therapy.
  • Signed requisition and patient consent.

Turnaround Time

3 working days from receipt of a suitable sample at the laboratory.

Limitations

  • The panel analyses defined hotspot regions and specified fusions in 50 genes. It is not whole-gene, whole-exome or whole-genome sequencing.
  • It analyses tumour tissue only and cannot distinguish somatic from germline alterations. Suspected hereditary cancer requires separate germline testing.
  • It does not assess BRCA1, BRCA2, mismatch repair genes, microsatellite instability (MSI), tumour mutational burden (TMB) or homologous recombination deficiency (HRD). PD-L1 protein expression is assessed by immunohistochemistry.
  • Low tumour content, suboptimal fixation or old blocks may reduce sensitivity. A negative result does not exclude alterations below the limit of detection or outside the regions analysed.
  • Results support, but do not replace, the clinical judgement of the treating oncologist.

Interpreting a negative result

A negative result means no reportable alteration was detected in the regions analysed. It does not exclude alterations below the limit of detection, outside the panel, or in samples with low tumour content. Where clinical suspicion remains high, repeat testing on another block or alternative testing may be considered.

Reporting & Follow-up

Report

Clinically significant variants are tiered according to the AMP/ASCO/CAP guidelines for somatic variant interpretation. Each finding is linked to approved targeted therapies and relevant clinical trials. Variants of uncertain significance are listed separately. The report also states sample quality and tumour content.

How results are reported

Each report is prepared by a qualified scientist, reviewed independently and signed out by an authorised specialist. Reports state the test performed, the regions analysed, the result and its interpretation, recommendations for follow-up and the limitations of the test.

Report: A signed report is sent to the referring doctor.

Genetic Counselling

This test analyses the tumour only. If an inherited cancer risk is suspected, separate germline testing and genetic counselling may be needed.

Charges & Downloads

Prices depend on the test and clinical situation. Ask our team for current price information.

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