APIS PIK3CA qPCR Kit

The APIS PIK3CA qPCR 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 kit includes mutation-specific probes to enable highly sensitive detection of the target mutations. Additionally, it uses PCR clamp and blocker technology, which ensures specific amplification of the mutant sequence, even in the presence of a high wild-type background.

Assay Mutations and Analytical Sensitivity

Synthetic DNA samples were prepared at ≤ 0.5% mutant allele frequency (MAF), with a total input of 5000 copies per reaction. A total of 24 replicates were generated per target, across 2 instruments and 2 kit lots. The Limit of Detection (LoD) is based on the highest MAF with ≥ 95% correct calls observed for each target. The LoD was established at ≤ 0.5% MAF for all targets (Table 1).

Table 1. Five PIK3CA mutations detected by the APIS PIK3CA qPCR Kit. LoD in % MAF.

APIS PIK3CA qPCR Kit Specifications

The kit has undergone testing as part of APIS unique RUO assay development pipeline, including both in silico and wet laboratory testing. As a result, researchers can depend on the kit for consistent and high-quality detection of PIK3CA mutations. A positive and negative control (PC and NTC), which monitor assay set up and assay performance, are also supplied with the kit.

Table 2. Kit specification for the APIS PIK3CA qPCR Kit.

APIS ESR1 Mutations and PIK3CA qPCR Kits Bundle - Achieve ≤ 0.5% MAF Detection

Discover the advanced capabilities of the APIS ESR1 and PIK3CA qPCR Kits, both designed to achieve a ≤ 0.5% Limit of Detection (LoD).

The APIS ESR1 Mutations Kit is an advanced qPCR assay for the sensitive and precise detection of mutations within the oestrogen receptor gene (ESR1). The APIS ESR1 Mutations Kit is a qualitative test, detecting eleven ESR1 mutations from DNA extracted from plasma (cfDNA).

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

For the APIS ESR1 Mutations Kit, additional testing with samples at 0.5% MAF has demonstrated that the kit can achieve mutation detection at ≤ 0.5% MAF with a wild-type (WT) background of 10,000 or 50,000 copies. This detection capability applies to the following mutations: E380Q, D538G, Y537S, Y537C, L536H, L536Q, Y537N, and P535H, each reaching ≤ 0.5% MAF sensitivity.

Mutations Detected by the APIS ESR1 Mutations Kit and APIS PIK3CA qPCR Kit

Table 3. The different mutations detected by both the ESR1 Mutations Kit and the PIK3CA qPCR Kit

APIS PIK3CA qPCR Kit

The APIS PIK3CA qPCR Kit is a Research Use Only (RUO) product. Not for use in diagnostic procedures.

For more information on this product please contact us and select ‘PIK3CA qPCR Kit’

Ordering Information

Product NameTest TypeKit SizeCatalogue NumberPrice
APIS PIK3CA qPCR KitRUO24 samples plus controls 03101 (distributed by APIS)Available upon request
APIS PIK3CA qPCR KitRUO24 samples plus controls03102 (distributed by Biocartis)Available upon request

Please visit the product web page, for the list of countries that Biocartis distributes the APIS PIK3CA qPCR Kit. APIS is the distributor for all other countries.

To order the APIS PIK3CA qPCR Kit or to learn more about how our assay can elevate your breast cancer research capabilities, please contact us by clicking below.