GENE ONLINE|News &
Opinion
Blog

.

Зеркало официального сайта всегда доступно для входа на Мостбет, даже при ограничениях. Скачать Mostbet – это шаг к удобству и азартным развлечениям.

Если вы ищете место для увлекательных ставок, обратите внимание на Joycasino, где лучшие предложения для игроков ждут вас.
last added cars
2018-07-11| Trials & Approvals

CFDA processes priority review of BGI’s BRCA1/2 gene testing kit

by GeneOnline
Share To

The BRCA1/2 gene mutation detection kit by the BGI Wuhan Ltd., a subsidiary of the Beijing Genomics Institute (BGI), received the priority reviewing notice from the Centre of Medical Device Evaluation, China Food and Drug Administration (CFDA) [1]. This BRCA1/2 gene testing kit is the first genetic test to be listed on the innovative medical device priority reviewing process.

By Joanne Shih

This BRCA1/2 gene mutation detection kit is performed with BGI’s in-house high-throughput sequencer and with combinatorial probe anchor synthesis (cPAS)-based sequencing method. This kit is designed for detecting germline variant of the exon and adjacent intron regions of BRCA1 and BRCA2 genes in patients with clinically diagnosed ovarian cancer and breast cancer.

The existence of BRCA1 and BRCA2 mutations is highly related to the efficacy of poly (ADP-ribose) polymerase (PARP) inhibitors when treating cancer. Therefore, being able to quantify the gene mutations in patients with BRCA-related cancers will allow clinicians to make more accurate treatment decision and advance the outcome of targeted therapy that uses PARP inhibitors.

If this BGI’s gene testing kit receive further approval from CFDA, it will be the first gene testing kit guiding the use of PARP inhibitors and may be beneficial to a large number of cancer patients.

Reference

  1. Centre of Medical Device Evaluation.CFDA: http://www.cmde.org.cn/CL0050/7586.html
  2. Okuma HS, Yonemori K. BRCA Gene Mutations and Poly(ADP-Ribose) Polymerase Inhibitors in Triple-Negative Breast Cancer. DOI. 10.1007/978-981-10-6020-5_13
  3. https://xueqiu.com/1912517390/110207640

 

©www.geneonline.com All rights reserved. Collaborate with us: [email protected]
Related Post
AI-Powered Blood Test Achieves 98% Accuracy in Early Breast Cancer Detection
2024-12-11
Antibody-Drug Conjugates: Connecting Drugs to Cancer Cells and Unlocking Billions in Market Opportunities
2024-11-06
Highlights from ESMO 2024: Key Oncology Advances from Major Pharmaceutical Companies
2024-09-19
LATEST
Beyond Pouch Packaging: Hanmi Pharmaceutical Introduces a New Automated Vial Dispensing Solution in Canada and the United States
2025-02-13
NASA Says There’s a 1 in 43 Chance an Asteroid 2024 YR4 Could Hit Earth in 2032—Should We Worry?
2025-02-13
Sodium Channel Targeting: What the Latest FDA Non-Opioid Approval Reveals About the Next Big Thing in Pain Relief
2025-02-12
Novartis Reclaims Abelacimab in $925M Deal to Boost Cardiovascular Portfolio
2025-02-12
GLP-1 Weight Loss Drugs Might Cause Blindness
2025-02-11
South Korea’s Olix Strikes $660M Deal with Eli Lilly for Phase 1 MASH candidate
2025-02-11
22 USA States Sue Trump Administration for Slashing Critical Medical Research Funding
2025-02-11
EVENT
2025-02-19
Healthcare Conference Taipei 2025
Taipei, Taiwan
2025-03-04
MIXiii Health-Tech.IL
Jerusalem, Israel
2025-03-05
Medical Japan
Osaka, Japan
2025-03-17
BIO-Europe Spring 2025
Milan, Italy
2025-04-21
World Vaccine Congress 2025
Washington, U.S.A
Scroll to Top