TEST:

APIS ESR1 Mutations Kit

The APIS ESR1 Mutations Kit demonstrated high sensitivity and specificity as a qualitative qPCR assay for detecting ESR1 mutations in varying WT backgrounds. Its performance with the SensID ESR1 Reference Set 1% AF cfDNA validated the kit's LoD at ≤1% MAF with external samples. The APIS kit is a valuable tool for assessing ESR1 mutations in both clinical and research settings, offering a more accessible alternative to traditional next-generation sequencing (NGS) and dPCR assays.

A dilution series of DNA fragments, ranging from 5 to 10,000 copies per reaction, was analyzed to determine linearity. The kit's performance was further assessed using the SensID ESR1

In conclusion, employing enrichment techniques for low-allele frequency variants can improve the sensitivity of ESR1 mutation detection in breast cancer. This approach has the potential to enhance our ability to monitor and respond to disease progression dynamically, ultimately supporting more effective, individualized patient care.

"PT Global Bioray Teknologi and APIS Assay Technologies Sign Collaboration to Commercialise the ESR1 Mutations Kit & the Breast Cancer Subtyping Kit..."

"Shiva Scientific and APIS Assay Technologies Sign Collaboration to Commercialise the APIS ESR1 Mutations Kit..."

The APIS ESR1 Mutations Kit showcased highly specific and sensitive detection of both the mutations present in the SensID ESR1 Reference Set 1% AF cfDNA and wildtype ESR1 from highly fragmented FFPE-derived DNA. Here, the kit’s LoD was affirmed at ≤1% MAF for cfDNA-based sample types and compatibility for detecting ESR1 mutations was demonstrated with both cfDNA and FFPEderived DNA samples.

The ESR1 Mutations Kit demonstrated highly sensitive and specific detection of the SensID ESR1 Reference Set 1% AF cfDNA, confirming the kit's LoD of ≤ 1% MAF with externally validated samples.

The ESR1 Mutations Kit demonstrated high sensitivity and performance as a qualitative qPCR assay to detect eleven ESR1 mutations. Mutations detected with the APIS ESR1 Mutations Kit

The APIS ESR1 Mutations Kit demonstrated high sensitivity and performance as a qualitative qPCR assay to detect 11 ESR1 mutations.

"Biocartis Group NV...announces the launch of the new Breast Cancer Portfolio during the Breast Cancer Awareness month: the Idylla™ PIK3CA-AKT1 Mutation Assay and, in collaboration with APIS Assay Technologies (APIS), the APIS Breast Cancer Subtyping Kit and the APIS ESR1 Mutations Kit."

"Biocartis Group NV...and APIS Assay Technologies Ltd...today announced the expansion of their partnership to include the commercialization of the APIS ESR1 Mutations Kit through Biocartis’ worldwide commercial network....'Together with the Idylla™ PIK3CA-AKT1 Mutation Assay and the APIS Breast Cancer Subtyping Kit we will be able to provide a comprehensive menu of products in the breast cancer domain to our customers.'"