AmoyDx® BRCA1 and BRCA2 Gene Mutation Detection Kit was approved by Chinese National Medical Products Administration (NMPA) on February 27, 2019, intended for qualitative detection of gene BRCA1 and BRCA2 mutation in patients with different cancer types including ovarian cancer and breast cancer. It is the first approved BRCA gene mutation detection product in China, also the second NGS-based testing kit from AmoyDx approved by Chinese Authority. AmoyDx® Essential NGS panel was approved by NMPA on November 20, 2018, for qualitative detection of gene mutations in patients with Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC).
BRCA1 and BRCA2 gene are tumor suppressor genes involved in DNA damage repair. Mutations in BRCA1 and BRCA2 genes have been linked to the development of hereditary breast cancer and ovarian cancer. BRCA gene mutation detection has also been highly recommended by many oncology clinical guidelines such as NCCN, CSCO and ASBrS guidelines, and the mutation testing results can guide use of PARP inhibitors such as Olaparib, surgical planning and screening for individual with high risk of ovarian cancer and/or breast cancer.
Ovarian cancer and breast cancer are the life-threatening malignant tumors that seriously affect the health of women all over the world.The treatment of ovarian cancer and breast cancer with PARP inhibitors opened a new era of targeted therapy. Currently, a number of PARP inhibitors have been approved worldwide, among which, Olaparib has been approved for the treatment of patients with ovarian cancer in China. About 50,000 women are diagnosed with ovarian cancer every year in China, which accounts for the highest death rate among all female cancers. . According to the clinical study data published by ESMO in October 2018, Olaparib significantly extended Progression-Free Survival (PFS) in BRCA-Mutated Advanced Ovarian Cancer.
Breast cancer is the most common female cancer in the United States with nearly 270,000 new cases every year. The clinical study data released by NEJM in 2017 shows that PFS of patients with BRCA-mutated gene and HER2-negative gene are significant longer with Olaparib therapy for breast cancer.
Companion Diagnostics (CDx) is critical to guide cancer targeted therapy. AmoyDx® BRCA1 and BRCA2 Gene Mutation Detection Kit can be used as CDx of Olaparib. Clinical data for registrations showed that patients with BRCA-mutated ovarian cancer which was detected by AmoyDx kit have significant clinical benefit from Olaparib treatment. The first approval of this product in China not only improves the development of NGS product in AmoyDx, but also provides effective solution on cancer mutation detecting to guide clinical precision oncology practice of the leading cancers in women.