AmoyDx® BRCA1 and BRCA2 Gene Mutation Detection Kit approved by Chinese Authority
Time:2019-03-01Source : AmoyDx

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.

For more information, please call us at +86-592-6806835 or email us at sales@amoydx.com.



Tel:+86-592-6806835
Email:sales@amoydx.com
BACK
Recommend
Visit AmoyDx at European Lung Cancer Congress 2019 in Geneva
27 /03
Visit AmoyDx at AACR Annual Meeting 2019 in Atlanta, USA
26 /03
AmoyDx® BRCA1 and BRCA2 Gene Mutation Detection Kit approved by Chinese Authority
01 /03
Welcome to visit AmoyDx on 17th Congress on Targeted Anticancer Therapies (TAT) in Paris
26 /02
Sanomics Limited and Amoy Diagnostics Partner to Deliver Multi-Gene Tests in Hong Kong and Macau
28 /01
AmoyDx ROS1 Kit Approval in Taiwan
18 /12
AmoyDx® Essential NGS panel approval from Chinese authority
21 /11
2018 AmoyDx Distributors Annual Meeting successfully held in Shanghai
11 /11
Visit AmoyDx at AMP Annual Meeting 2018 in USA
02 /11
AmoyDx ROS1 Gene Fusions Detection Kit was Approved by South Korea MFDS as Companion Diagnostics for Pfizer's Crizotinib
10 /10
Visit AmoyDx at the 19th World Conference on Lung Cancer (WCLC) 2018 in Canada
21 /09
Amoy Diagnostics achieved China NMPA Approval of Multi-Genes Mutations Detection Kit
24 /08
Meet AmoyDx at ELCC 2018 in Switzerland for NSCLC Molecular Testing
04 /04
China NMPA grants approval to AmoyDx Super-ARMS EGFR mutation test kit
22 /01
AmoyDx Distributors Annual Meeting (APAC-MEAF) 2017
05 /12
AmoyDx Distributors Annual Meeting (Europe) 2017
20 /11
Visit AmoyDx at MEDICA 2017, Germany
17 /11
Visit AmoyDx at MEDICA 2017 in Germany
20 /10
Amoy Diagnostics exhibits in the18th World Conference on Lung Cancer(WCLC) in Yokohama, Japan
20 /10
Detection sensitivity or therapeutic response prediction accuracy, which weighs more on NSCLC EGFR blood testing?
20 /09
Visit AmoyDx at WCLC 2017 of IASLC in Japan
16 /08
Amoy Diagnostics Co., Ltd. achieved IPO on Shenzhen Stock Exchange
02 /08
AmoyDx attended News Conference of Xalkori ROS1 approval in Japan
28 /06
AmoyDx to develop CDx for CANbridge Glioblastoma Candidate
22 /05
AmoyDx in European Lung Cancer Conference (ELCC) 2017
09 /05
Visit AmoyDx at ELCC 2017 in Switzerland
21 /04
AmoyDx HER2 Mutation Test Acting as Companion Diagnostics for Boehringer Ingelheim's Afatinib Study in NSCLC Patients
14 /02
AmoyDx ROS1 Fusion Test Kit was Approved by Japanese Authority as Companion Diagnostics Kit for Pfizer's Crizotinib
03 /02
TOP
Inquiry
* Required information
Manage your account info
Change your password