Research Assays

The APIS PIK3CA Mutations Kit is a real-time qualitative PCR test for the detection of the five most prevalent activating mutations in the PIK3CA gene, using DNA extracted from either formalin-fixed, paraffin-embedded (FFPE) breast tumour tissue (gDNA) or blood plasma (cfDNA).

The APIS ESR1 Mutations Controls serve as a quality control material and can be used for oestrogen receptor gene (ESR1) mutations assay validations, or alongside the APIS ESR1 Mutations Kit as run validity controls. The product consists of two tubes, a negative and a positive control. The positive control contains DNA fragments encoding eleven mutations within the ESR1 gene, as well as a reference sequence encoding a fragment of exon 3.

A digital PCR (dPCR) workflow allowing for reliable detection of mutations within the oestrogen receptor (ESR1) gene. The kit detects eleven ESR1 mutations across three exons: exon 5 (E380Q), exon 7 (S463P) and exon 8 (P535H, L536R, L536Q, L536H, L536P, Y537C, Y537S, Y537N and D538G).

*UNDER DEVELOPMENT

For the detection of the hypermutated phenotype associated with mutations in POLE and POLD1.

First-in-class cartridge-based assay for risk stratification of indeterminate thyroid nodules.

*UNDER DEVELOPMENT

Novel Gene Expression Signature for Primary Melanoma

An assay for the molecular characterization of hormone receptor positive (HR+) HER2 negative (HER2-) metastatic breast cancer. For Research Use Only.

The APIS ESR1 Mutations Kit is an advanced qPCR assay for the sensitive and precise detection of mutations within the oestrogen receptor gene. The APIS ESR1 Mutations Kit is a qualitative test, detecting eleven ESR1 mutations across three exons: exon 5 (E380Q), exon 7 (S463P) and exon 8 (P535H, L536R, L536Q, L536H, L536P, Y537C, Y537S, Y537N and D538G).

The APIS Breast Cancer Subtyping Kit is a highly reproducible, RNA-based diagnostic workflow for detecting mRNA expression of standard biomarkers (ER, PR, HER2, Ki67) and novel proliferative biomarkers from pre-operative core-needle biopsy (CNB) or resected formalin-fixed paraffin-embedded (FFPE) breast tumour tissue.

The fully automated Idylla™ IDH1-2 Mutation Assay Kit performs detection of 5 mutations in the isocitrate dehydrogenase 1 gene (IDH1) and 10 mutations in the isocitrate dehydrogenase 2 gene (IDH2).

The fully automated Idylla^TM MSI Assay performs detection of mutations in 7 novel MSI loci

Fully-automated detection of 21 KRAS mutations in exons 2,3 and 4 directly from 1ml plasma

Fully-automated detection of 21 KRAS mutations in exons 2,3 and 4 directly from a single slice of FFPE tissue

Fully-automated detection of 51 EGFR mutations in exons 18,19,20 and 21 directly from a single slice of FFPE tissue

Fully-automated detection of 7 BRAF mutations in codon 600 directly from a single slice of FFPE tissue

The fully automated Idylla GeneFusion Assay detects ALK, ROS1, RET, NTRK1/2/3 rearrangements & MET exon 14 skipping in a single cartridge.

Idylla ctEGFR covers 49 EGFR mutations in exons 18, 19, 20 & 21 and showed high concordance compared to NGS.

Fully-automated detection of 18 mutations in NRAS exons 2,3 and, 5 mutations in BRAF codon 600 as well as  2 EGFR mutations in codon 492 directly from a single slice of FFPE tissue

Fully-automated detection of 18 mutations in NRAS exons 2,3 and, 5 mutations in BRAF codon 600 as well as  2 EGFR mutations in codon 492 directly from 1ml plasma.