Table 2.
Summary of basic requirements
| Recommendation | |
|---|---|
| RAS mutation testing | |
| RAS mutation testing is recommended prior to first‐line chemotherapy to assess the benefit of anti–EGFR antibody therapy in patients with unresectable CRC. | Strong recommendation |
| RAS mutation testing can determine the optimal perioperative chemotherapy based on the presumed recurrence risk in patients with resectable CRC. | Expert Consensus Opinion |
| BRAF mutation testing | |
| BRAF V600E mutation testing is recommended prior to first‐line chemotherapy to determine the optimal treatment based on the prognosis of patients with unresectable CRC. | Strong recommendation |
| BRAF V600E mutation testing is recommended to determine the optimal perioperative chemotherapy based on the presumed recurrence risk in patients with resectable CRC. | Recommendation |
| BRAF V600E mutation testing is recommended to help diagnose Lynch syndrome. | Recommendation |
| Testing for mismatch repair deficiency | |
| MMR deficiency testing is recommended to evaluate the benefit of immune checkpoint inhibitors in patients with unresectable CRC. | Strong recommendation |
| MMR deficiency testing is recommended to assess the risk of recurrence and to stratify optimal perioperative chemotherapy in patients with resectable CRC. | Recommendation |
| MMR deficiency testing is recommended to screen for Lynch syndrome. | Strong recommendation |
| The following methods are recommended when assessing for MMR deficiency: | |
| MSI testing | Strong recommendation |
| IHC testing | Strong recommendation |
| NGS‐based testing | Recommendation |
| Next‐generation sequencing‐based comprehensive genomic profiling tests | |
| Comprehensive genomic profiling tests are recommended to assess the benefits of molecular targeted drugs in patients with unresectable CRC. | Strong recommendation |
| Liquid biopsy | |
| ctDNA testing is recommended to determine the optimal perioperative chemotherapy based on the presumed recurrence risk of patients with resectable CRC. | Recommendation |
| ctDNA testing is recommended to evaluate the suitability of and to monitor the therapeutic effects of anti–EGFR antibody therapy in patients with unresectable CRC. | Recommendation |
| ctDNA‐based comprehensive genomic profiling tests are recommended to assess the benefits of molecular targeted drugs for patients with unresectable CRC. | Recommendation |
| Angiogenic factors | |
| Measurement of VEGF‐D level is performed to identify the appropriate angiogenesis inhibitors for patients with unresectable CRC. | Expert Consensus Opinion |
| Samples for molecular testing | |
| FFPE tissue is suitable for genomictesting of somatic mutations. It is recommended to confirm that the samples have an adequate amount of tumor cells and expect sufficient quality of nucleic acids by assessing the matched reference hematoxylin and eosin stained slides. Selection of FFPE samples, decision on the need for macrodissection, and assessment of tumor cell content should be performed by a pathologist. | Strong recommendation |
| In ctDNA testing, use of collection tubes and the preservation and adjustment of plasma after blood collection should be performed in accordance with the manufacturer’s instructions. | Strong recommendation |
| Quality assurance requirements for testing | |
| Genomic testing for CRC treatment should be carried out under a quality assurance system. | Strong recommendation |
Abbreviations: CRC, colorectal cancer; ctDNA, circulating tumor DNA; EGFR, epidermal growth factor receptor; FFPE, formalin‐fixed paraffin‐embedded; IHC, immunohistochemistry; MMR, mismatch repair; NGS, next‐generation sequencing; VEGF, vascular endothelial growth factor.