Recently, the " Human K-ras Gene Mutations Detection Kit (multiplex fluorescence PCR method)" developed by XIAMEN SPACEGEN CO.,LTD. (hereinafter referred to as " Spacegen ") based on the PCR technology platform has passed the review of the Chinese State Drug Administration (NMPA) and officially approved the registration certificate of class III medical devices (National Machinery registration standard 20223400275).This approval once again proves the leading position of Spacegen in the field of molecular diagnosis.

As one of the companion diagnostic detection kits, the wild-type K-ras gene used for qualitative detection for colorectal cancer patients can assist clinicians in judging the benefits of patients using cetuximab injection.

As an antitumor drug, cetuximab can specifically bind to EGF receptors expressed on the surface of normal cells and a variety of cancer cells, and competitively block EGF and other ligands.

K-ras gene is a member of RAS gene family. Among RAS genes, K-ras has the greatest impact on human cancer. It is like a molecular switch: it controls the path of regulating cell growth when normal; But ，when abnormality occurs, it will lead to the continuous growth of cells ，prevents cells from self-destruction K-ras gene is involved in intracellular signal transmission. When K-ras gene is mutated, the gene is permanently activated and cannot produce normal Ras protein, resulting in disorder of intracellular signal transduction, uncontrolled cell proliferation and canceration.96% of K-ras gene mutations occurred in codons 12 and 13 of exon 2.As the most important effector downstream of EGFR signaling pathway, K-ras gene plays an important role in tumor signal transduction.

Many authoritative guidelines at home and abroad point out that patients with colorectal cancer should be tested for RAS and BRAF genes, so as to formulate more effective and personalized treatment plans.

The diagnostic kit for KRAS gene mutation of Spacegen has been approved in China, which is expected to provide more treatment options for patients with colorectal cancer and benefit public health. For patients with inoperable NSCLC, KRAS gene mutation was detected before systematic treatment, and treatment was guided according to molecular typing. If tissue samples are inaccessible, circulating tumor DNA can be considered for detection. On the other hand, for metastatic colorectal cancer, KRAS gene mutation detection should be carried out before neoadjuvant chemotherapy in the potentially resectable group or systematic treatment in the palliative treatment group to master the drug resistance of mutated patients to cetuximab.

In recent years, based on digital PCR platform, fluorescence quantitative PCR platform, high-throughput sequencing platform and nucleic acid mass spectrometry platform, Spacegen has independently developed a full range of tumor accurate diagnosis products, and has a variety of products approved by the State Drug Administration (NMPA).At present, Spacegen has produced a series of tumor accurate diagnosis kits, which have been adopted by domestic hospitals and enterprises and have been highly recognized in the industry.

This certification is one of the many achievements made by Spacegen in the field of precision treatment .The company continued to maintain a stable pace of research and development, innovatively launched products conducive to the progress of precision medicine, and boosted the cause of molecular diagnosis to a higher level.