Amoy Diagnostics Co., Ltd. products

The AmoyDx Comprehensive Panel (Reversible Terminator Sequencing) is a next-generation sequencing (NGS) based assay intended for the qualitative detection of single nucleotide variants (SNVs), insertions and deletions (indels), gene fusions, and copy number variations (CNVs) in 110 genes, single nucleotide polymorphisms (SNPs) in 19 genes, and tumor microsatellite instability (MSI) status. The assay allows the detection of SNVs, Indels, fusions, CNVs, SNPs and MSI using DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue specimens, and the detection of SNVs, indels, fusions and SNPs using circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood specimens. The kit is intended to be used by trained professionals in a laboratory environment.

The Homologous Recombination Repair (HRR) pathway plays an important role in the repair of double-strand breaks, which is a major cause of cancer development. It has been demonstrated that loss of function of HRR genes, Homologous Recombination Deficiency (HRD) is the inability to repair double strand breaks and will cause a higher risk of developing cancer^[1-5]. Patients with HRD showed higher responses to poly ADP ribose polymerase inhibitors (PARPi) and platinum-containing therapies^[6-7]. HRD Score testing and BRCA1/2 mutations testing have been approved for patient selection for PARPi therapy.

The AmoyDx HANDLE Classic NGS Panel (Reversible Terminator Sequencing) is a multi-biomarker next generation sequencing (NGS) assay that enables the detection of variants in 40 key solid tumor genes and microsatellite instability (MSI) status using DNA and RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The assay allows concurrent analysis of DNA and RNA to simultaneously detect single nucleotide variants (SNVs), insertions and deletions (InDels), fusions, copy number amplifications (CNAs) and MSI in a single workflow. The kit is intended to be used by trained professionals in a laboratory environment.

The AmoyDx BRCA1 and BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing) is intended for qualitative detection of  BRCA1 and BRCA2 variants using DNA isolated from peripheral whole blood, fresh-frozen tissue or formalin-fixed paraffin-embedded (FFPE) tissue samples. The kit provides full and uniform coverage of both BRCA1 and BRCA2 genes, covering all coding exons, exon/intron junctions, some introns and UTR regions. The kit allows the detection of single nucleotide variants (SNVs) and insertions and deletions (Indels) from tissue-derived DNA, and the detection of SNVs, Indels, and large rearrangements (LRs) from blood-derived DNA. The kit is intended to be used by trained professionals in a laboratory environment.