Sansure’s Tumor Personalized Medicine Gene and Tumor Genetics Risk Assessment Diagnostic Products Received CE Approval
15th August 2017

Recently, Sansure Biotech Inc. independently developed BRAF, EGFR, KRAS and PIK3CA tumor personalized medicine gene diagnostic kits, and BRCA1/2 tumor genetics risk assessment diagnostic kit had received CE approval, officially listed abroad.


Gene Mutation Detection and Tumor Personalized Medicine

Personalized medicine helps doctors learn about a person’s genetic makeup and how their tumor grows. With this information, doctors hope to find prevention, screening, and treatment strategies that may be more effective. They also want to find treatments that cause fewer side effects than the standard options. By performing genetic tests on the cancer cells and on normal cells, doctors may be able to customize treatment to each patient’s needs. A lot of studies demonstrated that EGFR, KRAS, PIK3CA, BRAF and other gene mutation detection is closely related to tumor personalized medicine.


EGFR (Epidermal Growth Factor Receptor) Gene

The EGFR gene is located on human chromosome 7, spans approximately 118 kb, which encodes the Epidermal Growth Factor Receptor. Mutations in the EGFR oncogene are found in human cancers. Researchers have found that the most common mutations in EGFR gene are on the exon 18~21, and the presence of these mutations correlates with response to certain tyrosine kinase inhibitor (TKI) cancer therapies in patients with non-small cell lung cancer (NSCLC).



The KRAS gene is located on human chromosome 12, spans approximately 35 kb, which belongs to the RAS gene family. The protein encoded by this gene is related to the generation, proliferation, migration, proliferation and angiogenesis of tumor. The study found that the most common mutations in KRAS gene are codon 12 and 13 on the exon 2, and the mutation status directly affects the therapeutic efficacy of medicine targeted EGFR (epidermal growth factor). Therefore, the detection of KRAS gene mutations can provide a more accurate basis for individual treatment on cancer patients 



Mutations in the PIK3CA oncogene are frequently found in human cancers. PIK3CA mutations occur in approximately 15% of breast cancer or colorectal cancer, which are mainly on the exon 9 and exon 20. The clinical usefulness of these mutations is under investigation.



The BRAF gene is a serine/threonine kinase that functions within the RAS-RAF-MEK-MAPK pathway. This pathway normally regulates cell proliferation and survival under the control of growth factors and hormones. The most common alteration in the BRAF gene is a mutation called V600E, which alters the valine at position 600 in the protein to a glutamic acid. Other mutations observed at the V600 position are V600D, V600K and V600R. Mutations in the BRAF gene have been associated with the development of cancer. BRAF mutations occur in approximately 60% of melanoma tumors, approximately 44% of papillary thyroid tumors, and~15% of colorectal tumors.


Sansure’s BRAF, EGFR, KRAS and PIK3CA gene mutation diagnostic kits adopt unique amplification system which is able to reduce nonspecific amplification markedly and read result directly (without ΔCt calculation lead to objective result reading). The sensitivity is up to 1% and covered more mutation gene types enable doctors to make personalized medicine strategies for patients with Non-small Cell Lung Cancer (NSCLC), colorectal cancer, breast cancer, ovarian cancer, melanoma, pancreatic cancer and other cancers effectivity


BRCA1/2 Gene VS. Breast Cancer & Ovarian Cancer

BRCA1/2 gene mutations are closely related to the incidence and high risk of familial breast and ovarian cancer. Women carrying a BRCA mutation have up to an 87% lifetime chance of breast and 54% chance of ovarian cancers (vs. general population: 12% breast and < 1% ovarian). Poly (ADP-ribose) polymerase inhibitors (PARPs) have shown promising activity in patients with BRCA1/2 mutated ovarian and breast cancers. A preplanned retrospective subgroup analysis showed that treatment with Olaparib extended progression-free survival (PFS) by 6.9 months for ovarian cancer patients with the BRCA1/2 mutations (11.2 months vs 4.3 months) compared to placebo.


Sansure’s Human BRCA1/2 Sequencing Panel Kit (Next Generation Sequencing) is intended to build up the sequencing library which contains complete BRCA1/2 gene exon region and variable shear zone with high specificity and passed high-throughput sequencing and bioinformatics analysis. The kit enable doctors to acquire BRCA1/2 gene mutation information of tested sample, to provide guidance in the medical strategies making, prevalence risk and recurrence risk assessment, early medical intervention or genetic diseases prevention for patients.

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