BGI Genomics Co., Ltd (SHE: 300676), a leading genomics company based in China, has announced an unsuccessful market filing for its BRCA1/2 gene mutation detection kit, which utilizes the combined probe anchored polymerization sequencing method. The company cited the failure to complete the required complement and correction of information as the reason for the filing’s rejection.
This detection kit is designed for qualitative gene detection in patients with ovarian and breast cancer and plays a crucial role in guiding ovarian cancer patients to use Lynparza (olaparib) for maintenance therapy. The clinical trial supplementation period coincided with stringent public health prevention and control measures, leading to delays. The primary requirement for data supplementation was to add pharmacodynamic clinical trial data and related information for the applicable population of the accompanying diagnostic drug. As some enrolled subjects have not yet reached the required efficacy follow-up endpoint, the data supplementation could not be completed within the scheduled timeline. BGI intends to refile once the remaining participants have completed the efficacy follow-up.- Flcube.com
