Minimum content of reports for RAS testing of CRC to guide anti-EGFR therapy
| Report item | Example |
|---|---|
| The tested tissue block reference number | Laboratory reference number: 1234–14 |
| The neoplastic cell content of the tissue (macrodissected or not) from which DNA was extracted | The sample of tissue macrodissected for RAS analysis had an estimated neoplastic cell content of 40% |
| The analytical method used, including the version number of the kit (if used), the scope and the limit of detection (LOD) of the assay* | Pyrosequencing using the Therascreen Qiagen RGQ PCR kit, which assays 7 KRAS mutations (12Ala, 12Asp, 12Arg, 12Cys, 12Ser, 12Val and 13Asp). Assay LOD 1–5% |
| The result | KRAS mutation present |
| The nucleotide and the amino acid changes (using HGVS nomenclature†), if specified by the testing method | c.35G>T p.Gly12Val |
| A clinical interpretation of the result | The patient is unlikely to respond to anti-EGFR therapy |
*It is essential that the requestor of RAS testing understands what proportion of RAS mutations have been tested for, particularly in the event of a wild-type result.