APIS ESR1 dPCR Kit

The APIS ESR1 dPCR Kit is 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).

Analytical Sensitivity

The Limit of Detection (LoD) was established for each target using samples contrived with wild-type (WT) and mutant DNA at 0.1% mutant allele frequency (MAF). A total of 6 replicates were generated per target, across one instrument and two kit lots. The LoD was defined as the highest MAF with 100% correct calls.

Table 1. Mutations detected by the APIS ESR1 dPCR Kit. LoD in % MAF and copies. The mutant copies at LoD and WT copies at LoD describe the copies of each DNA fragment in the contrived LoD samples.

The APIS ESR1 dPCR Kit Ligand-Binding Domain (LBD) Point Mutations

Figure 1. ESR1 ligand-binding domain (LBD) point mutations detected by the APIS ESR1 dPCR Kit

Analytical Specificity

The Limit of Blank (LoB) was determined by testing mutation-negative samples contrived with WT DNA fragments (10,000 and 20,000 copies). For each target, the overall rate of correct sample interpretation was 100%.

APIS ESR1 dPCR Kit Specifications

The kit has undergone testing as part of the APIS unique assay development pipeline, which includes in silico and wet laboratory testing. An appropriate instrument and compatible dPCR enzyme mix, suitable for use with probe-based chemistry, is required for use.

APIS ESR1 dPCR Kit

The APIS ESR1 dPCR Kit is currently available as a Research Use Only (RUO) product. Not applicable for use in diagnostic procedures.

For more information on this product please contact us and select ‘ESR1 dPCR Kit’

Ordering Information

Product NameTest TypeKit VolumesCatalogue NumberPrice
APIS ESR1 dPCR KitRUOPP mixes: 252 μL, Controls: 210 μL03301 (distributed by APIS)Available upon request
APIS ESR1 dPCR KitRUOPP mixes: 252 μL, Controls: 210 μL03302 (distributed by Biocartis)Available upon request

Biocartis distributes directly to the following countries: Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of Cyprus, Republic of Ireland, Slovenia, Spain, Sweden, Switzerland.

Biocartis distributes via local distributors to the following countries: Colombia, Ecuador, Estonia, Hong Kong, Mexico, Philippines, Thailand.

APIS is the distributor for all other countries.

To order the APIS ESR1 dPCR Kit or to learn more about how our assay can elevate your breast cancer research capabilities, please contact us below.