|Clinical application of companion diagnostics in colorectal cancer
Companion diagnosis (CDX) is the core subdivision of in vitro diagnostics and the cornerstone of precision medicine for tumors. In order to standardize diagnosis and treatment and ensure the prognosis of patients, the National Health Commission has formulated the Chinese Colorectal Cancer Diagnosis and Treatment Standards (2023 Edition), which recommends that patients with early-stage colorectal cancer undergo prognosis and risk assessment through KRAS, NRAS and BRAF gene mutation testing, and recommends the detection of the above gene mutations in patients with clinically confirmed or metastatic colorectal cancer, so as to better guide clinical medication. It has been reported that in patients with metastatic colorectal cancer, patients with RAS wild-type can achieve survival benefits and improved outcomes with specific precision-targeted** drugs (e.g., anti-EGFR monoclonal antibodies). BRAF is an important signaling molecule in the EGFR signaling pathway, and its mutation can lead to continuous activation downstream of the MAPK pathway, resulting in abnormal differentiation, proliferation, metabolism and growth of tumor cells. Therefore, BRAF mutations are an important negative prognostic factor for colorectal cancer, and the most common mutation form is BRAF V600E mutation, which has an incidence of 54%~5.7%。
|Colorectal cancer-related biomarkers and corresponding targeted immunization**
Colorectal cancer detection testRecommendations for reference product settings1.Positive reference.
Ideally, the positive reference should include a quality control sample for each genotype of the declared product. However, considering the large number of detectable genes based on NGS technology, the applicant should make a targeted and representative design based on factors such as the intended use, clinical significance, and gene type of the product.
For genes that are clearly related to tumor companion diagnosis, the rationality and completeness of the gene reference setting should be considered, and all hot genes related to companion diagnosis should be included, and it is recommended to use nucleic acid stock solutions extracted from clinical samples or cell lines as raw materials.
For genes of significant or potential clinical significance, consideration should be given to the issue of representativeness to identify the types of genes that are clinically diagnostic and the different types of variants within the genotype. The selection of mutation frequency and variant type should be representative, including different exons, different gene mutations, etc.
The positive reference set is the most complex, focusing on clinically significant loci and not requiring full coverage. Priority is given to targets and biomarkers for clinical drug development
2.Negative reference.
Negative references and negative controls are recommended to be mixtures or cell lines of normal clinical samples, which should clearly do not contain tumor mutations in the target region.
|Starfish Biotech's colorectal cancer detection reference solution
The above content is provided by Starfish Biotech.
Our Services: CRISPR Cas9 Cell Gene Editing, Vector Construction, Virus Packaging, Molecular Diagnostic Standards, Mutant Gene Standards, Fusion Gene Standards, Cell Stabilization, Cell Interference.
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