Product Features
·Comprehensive detection coverage
·Matched fully-automatic reporting system
·Continuously updated proprietary database
·The only NMPA-approved BRCA1/BRCA2 companion diagnostic for prostate cancer in China
Product Description
The Human BRCA1/BRCA2 Gene Mutation Detection Kit (Reversible-Terminator Sequencing) leverages Amoy Diagnostics’
in-house developed HANDLE® library-preparation technology. It features simple operation, short turnaround time, comprehensive detection coverage and a powerful exclusive bioinformatics analysis system, delivering accurate and reliable test results. Approved by the National Medical Products Administration (NMPA), this kit serves as a companion diagnostic for Niraparib and Abiraterone Acetate Tablets (AKEEGA®) and Olaparib Tablets.
Simple operation & short reporting turnaround: Library construction can be finished in as fast as 6 hours, greatly shortening the turnaround time (TAT).
Comprehensive detection coverage: For in-vitro qualitative detection of single-nucleotide variants (SNVs), insertions/deletions (InDels) and homozygous deletions (HD) within the coding regions, exon-intron junctions and untranslated regions (UTRs) of human BRCA1 and BRCA2 genes, using 10% neutral formalin-fixed, paraffin-embedded (FFPE) tissue specimens from prostate cancer patients.
Integrated fully-automatic reporting system: Developed based on proprietary patented technology (Chinese Invention Patent No. ZL201610460870.6). It provides a graphical user interface and fully-automated analysis-and-report workflow. Its built-in database integrates variant data from major public databases plus over 50000 in-house test records, with continuous updates for variant interpretation data.
Product Registration Certificates
Registration Numbers: NMPA Registration No. 20253402685, NMPA Registration No. 20263401004
Note: This product is NMPA-approved in China and is currently intended for the Chinese market only. It is not commercially available outside China.
·Comprehensive detection coverage
·Matched fully-automatic reporting system
·Continuously updated proprietary database
·The only NMPA-approved BRCA1/BRCA2 companion diagnostic for prostate cancer in China
Product Description
The Human BRCA1/BRCA2 Gene Mutation Detection Kit (Reversible-Terminator Sequencing) leverages Amoy Diagnostics’
in-house developed HANDLE® library-preparation technology. It features simple operation, short turnaround time, comprehensive detection coverage and a powerful exclusive bioinformatics analysis system, delivering accurate and reliable test results. Approved by the National Medical Products Administration (NMPA), this kit serves as a companion diagnostic for Niraparib and Abiraterone Acetate Tablets (AKEEGA®) and Olaparib Tablets.
Simple operation & short reporting turnaround: Library construction can be finished in as fast as 6 hours, greatly shortening the turnaround time (TAT).
Comprehensive detection coverage: For in-vitro qualitative detection of single-nucleotide variants (SNVs), insertions/deletions (InDels) and homozygous deletions (HD) within the coding regions, exon-intron junctions and untranslated regions (UTRs) of human BRCA1 and BRCA2 genes, using 10% neutral formalin-fixed, paraffin-embedded (FFPE) tissue specimens from prostate cancer patients.
Integrated fully-automatic reporting system: Developed based on proprietary patented technology (Chinese Invention Patent No. ZL201610460870.6). It provides a graphical user interface and fully-automated analysis-and-report workflow. Its built-in database integrates variant data from major public databases plus over 50000 in-house test records, with continuous updates for variant interpretation data.
Product Registration Certificates
Registration Numbers: NMPA Registration No. 20253402685, NMPA Registration No. 20263401004
Note: This product is NMPA-approved in China and is currently intended for the Chinese market only. It is not commercially available outside China.
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