BGI Genomics Homologous Recombination Deficiency Detection Kit receives CE-IVDD certification


BGI Genomics announces that its Homologous Recombination Deficiency Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method) has recently obtained CE-IVDD approval.

This kit is developed for the qualitative detection of genomic homologous recombination deficiency (HRD) based on high-throughput sequencing technology, and adopts the combinatorial probe-anchor synthesis sequencing method.

HRD is a functional defect in homologous recombination DNA repair (HRR). It is characterized by the inability of cells to effectively repair DNA double-strand breaks using the HRR pathway1. The occurrence of HRD is associated with several mechanisms. One of them is gene mutations of BRAC1/2, which are highly related to breast and ovarian cancers.

The significance of HRD detection is that it could predict the efficacy of PARP (poly ADP-ribose polymerase) inhibitor for ovarian and breast cancer patients. HRD status is positively correlated with the efficacy of PARP inhibitor. Studies have shown that HRD-positive patients who were treated with PARP inhibitor have enhanced chances of survival compared with those patients whose HRD status is negative.

Tissue samples or paraffin-embedded tissue samples (FFPE) of solid tumor patients are applicable for this test. The test results and clinical evaluation of patients' actual situations will help clinicians plan and propose precision treatment options to patients.

1. Stewart MD, Merino Vega D, Arend RC, et al. Homologous Recombination Deficiency: Concepts, Definitions, and Assays. Oncologist. 2022;27(3):167-174.

About BGI Genomics 

BGI Genomics, headquartered in Shenzhen China, is the world’s leading integrated solutions provider of precision medicine. Our services cover more than 100 countries and regions, involving more than 2,300 medical institutions. In July of 2017, as a subsidiary of BGI Group, BGI Genomics (300676.SZ) was officially listed on the Shenzhen Stock Exchange.