Dispense Ready (DR) and Ready-to-Use (RTU)

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® Liquid PIK3CA qPCR Assay is supplied as four simplex product variants each one targeting a specific mutation in the human PIK3CA gene.

Genomic targets:
PIK3CA E542K Simplex (P4)
PIK3CA E545K Simplex (P5)
PIK3CA H1047L Simplex (P6)
PIK3CA H1047R Simplex (P7)

SensiScreen^® Liquid PIK3CA qPCR Assay

PIK3CA E542K Simplex (P4):
20 reactions DR: 5585
12 reactions RTU: 5591

PIK3CA E545K Simplex (P5):
20 reactions DR: 5586
12 reactions RTU: 5600

PIK3CA H1047L Simplex (P6):
20 reactions DR: 5601
12 reactions RTU: 5592

PIK3CA H1047R Simplex (P7):
20 reactions DR: 5587
12 reactions RTU: 5590

SensiScreen^® Liquid PIK3CA qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the PIK3CA Mutational Status.

Each product variant is supplied as both a Dispense Ready (DR) and a Ready-to-Use (RTU) version. DR assays include oligonucleotide mixtures and Master Mix in separate tubes which need to be dispensed into suitable plasticware before addition of template. RTU assays are pre-dispensed in PCR strip tubes and only need the addition of template before real-time qPCR amplification.

SensiScreen^® Liquid PIK3CA qPCR Assay combines allele-specific PCR with PentaBase’s novel and selective technologies comprising both HydrolEasy^® probes, SuPrimers™ and BaseBlockers™ for specific and sensitive target amplification. The SensiScreen^® Liquid PIK3CA qPCR Assay is based on PentaBase’s unique intercalating nucleic acid (INA^®) technology and the inclusion of intercalating pseudonucleotides (IPNs), which are synthetic DNA analogues comprising a flat heteroaromatic, hydrophobic molecule and a linker. IPN molecules are inserted into the oligonucleotides at fixed positions during oligonucleotide synthesis. The SensiScreen^® Liquid PIK3CA qPCR Assay contains both standard and INA^® oligonucleotides.

Intended purpose:
SensiScreen^® Liquid PIK3CA qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the detection, identification, and relative quantification of specific somatic mutations in the human phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) gene in cell-free DNA (cfDNA) purified from liquid biopsies including plasma and serum. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or manual workflows.
The assay is an in vitro diagnostic medical device intended for patients already diagnosed with PIK3CA mutation to aid in disease monitoring based on PIK3CA mutation status. The test result correlates with the amount of PIK3CA mutant cfDNA. Results can be used to determine changes in PIK3CA mutation quantity levels in patients over time such as during cancer interventions or during follow-up. It is not intended as a companion diagnostic device.

Intended user:
SensiScreen^® Liquid PIK3CA qPCR Assay is intended to be used by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical conclusions based on results from this product require medical authorization.

Procedure:
Designed to run on open platforms with at least two-channels (green and yellow)

Validated Real-Time PCR instruments:
BaseTyper™ and CFX96 Touch (Bio-Rad)

PentaBase technologies:
Based on our INA^® technology. The mutation-specific assays contain a HydrolEasy^® probe, a BaseBlocker™, a mutation-specific primer set and an internal control assay

Genomic target:
Codons 542, 545 and 1047 of the human PIK3CA gene

Sample types:
Liquid biopsies

Sample DNA extraction methods:
cfDNA extraction kits and/or procedures specially designed for handling of liquid biopsy samples according to the manufacturer´s instructions

Sample input:
5 ng DNA or less per reaction

PCR run time:
Less than 2 hours

For the latest version of the Instructions For Use (IFU) – Click here –

Kindt et al. – ResearchGate – 2024 – Click here – for article