Approved PARP inhibitors and their accompanying diagnostic test reagents

Up to now, FDA and NMPA have approved six PARP inhibitors for treatment or maintenance treatment, involving breast cancer, ovarian cancer, pancreatic cancer and prostate cancer. Among them, ovarian cancer is the most approved use.

Only two HRD detection products in the world have been verified by large-scale phase III clinical research and approved by the US FDA: Myriad myChoice? CDX (Meliard Gene Laboratory Co., Ltd.) and FoundationFocus? CDx BRCA LOH (Basic Medical Company). In Myriad MyChoice? In CDx detection, HRD positive was defined as BRCA 1/2 mutation and/or GIS score ≥ 42. GIS score is calculated by LOH, TAI and. The threshold was set according to the 5th percentile HRD score of ovarian cancer and breast cancer samples with BRCA deficiency, and it was proved for the first time that it could effectively predict the chemosensitivity of breast cancer and ovarian cancer to platinum-containing drugs. At FoundationFocus? In the detection of CDx BRCA LOH, HRD positive was defined as tumor BRCA 1/2 mutation and/or genome LOH score ≥ 16%. The threshold is initially set according to its effective differentiation of chemotherapy effect of platinum-containing drugs on ovarian cancer patients, and then adjusted according to its differentiation of therapeutic effect of rucaparib on ovarian cancer patients.

Ability to give human resources development scores; It is enough to give the mutation detection results of BRCA species or systems; The detection results of HRRm gene mutation can be given.