Original from: AmoyDx
Amoy Diagnostics Co., Ltd. (¡°AmoyDx,¡± SZSE: 300685) today announced that its AmoyDx® HRD Complete Panel has received certification under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) by TÜV SÜD Product Service GmbH for use as a companion diagnostic to aid in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations ( germline and /or somatic) who may be eligible for treatment with olaparib monotherapy who have progressed following prior therapy that included a novel hormonal agent.
The AmoyDx® HRD Complete Panel is an NGS-based in vitro diagnostic assay designed to detect and classify genomic alterations in homologous recombination repair (HRR) genes from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens from prostate cancer patients. Detection of pathogenic or likely pathogenic BRCA1 and BRCA2 variants, including single nucleotide variants (SNVs), insertions and deletions (InDels), and homozygous deletions (HDs), was approved for use as a companion diagnostic for olaparib.
The AmoyDx® HRD Complete Panel is the first IVDR CDx product developed and launched by a Chinese diagnostics company. The IVDR certification marks an important milestone in AmoyDx¡¯s European expansion and further strengthens the company¡¯s capabilities in companion diagnostic development and global regulatory registration.
Beyond the CDx biomarkers, the Panel also covers additional genes, including ATM, BARD1, BRIP1, CDH1, CDK12, CHEK1, CHEK2, FANCA, FANCL, HDAC2, PALB2, PPP2R2A, PTEN, RAD51B, RAD51C, RAD51D, RAD54L and TP53, which have undergone extensive analytical evaluation and validation by AmoyDx.
AmoyDx will continue to collaborate with global pharmaceutical partners to advance the development, regulatory registration and global application of companion diagnostic solutions, further expanding its international precision oncology footprint.
