PIK3CA Mutation Detection Test | DiaCarta, Inc.

To aid in the identification of patients eligible for treatment and to monitor response to therapy, DiaCarta offers QClamp® PIK3CA Mutation Detection Test in plasma and Formalin-Fixed Paraffin-Embedded (FFPE) samples which can lead to improved outcomes in cancer patients. The QClamp® PIK3CA Mutation Detection Test is an in vitro diagnostic real-time qualitative PCR assay for the detection of somatic mutations in and near codons 542 and 545 in Exon 9 and codon 1047 in Exon 20 in the human PIK3CA gene, using purified DNA extracted from FFPE or plasma.

Learn More about QClamp® Assays >

Powered by XNA technology, the QClamp® PIK3CA Mutation Detection Test has achieved a much higher analytical sensitivity compared to other commercial qPCR kits and other cancer gene mutation detection methods. QClamp® PIK3CA Mutation Detection Test is able to detect reliably 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted mutations, providing lower detection limit compared with competition due to a strict enrichment of mutant sequences while suppressing amplification of wild-type sequences.

QClamp® PIK3CA Mutation Detection Test is CE/IVD-certified.

Advantages of QClamp® PIK3CA Mutation Detection Test


Detect reliably 0.1% to 0.5% VAF mutant DNA out of wild-type DNA for targeted mutations


Suitable for plasma and FFPE samples


Minimum 5ng input DNA per reaction. Less than 2 tubes of blood (10mL each) needed for cfDNA


Covering all relevant somatic mutations in 4 codons of PIK3CA oncogene


Less than 4 hours of assay run time


Validated on the most common qPCR machines with minimized variability

PIK3CA Mutation and Cancer

PIK3CA Introduction

PIK3CA (Phosphoinositide 3-kinases or PI3-Kinases) are family of lipid kinases capable of phosphorylating the 3’ position hydroxyl group of the inositol ring of phosphatidylinositol. They are involved in regulating cell growth, proliferation. Activating mutations in PIK3CA catalytic domain of the p110alpha subunit (PIK3CA) have been found at 25~40 % frequency in various types of tumors including colorectal cancer, breast and endometrial cancers, and other cancers and are associated with poor prognosis. About 80 % of the point mutations presides in exon 9 and exon 20 and they have been associated with resistance to cetuximab therapy in patients with colorectal cancer.

PIK3CA Mutations

Not occurred frequently in lung cancers, PIK3CA mutations in lung cancer can identify groups with prognostic relevance. Because activation of PI 3 kinase pathway can come from mutations of upstream regulators, such as receptor tyrosine kinases, PTEN and RAS proteins, or even mutations in the kinase itself, effective therapeutic agent against PI 3 kinase has been very challenging.

Streamlined Workflow for QClamp® PIK3CA Mutation Detection Tests

Step 1: DNA Isolation & Quantification

Extract DNA from FFPE or plasma using a commercial DNA extraction kit followed by measuring the concentration using fluorometric analysis

Step 2: set up qpcr

Mix the assay reagents, load into PCR plate, add controls and extracted DNA ~ 30-60 minutes

Step 3: Amplification parameters

Enter amplification parameters on
qPCR instrument, load PCR plate
and start the run ~ 2.5 hours

Step 4: Data analysis

Determine the presence or absence
of mutations according to the Cq
value cutoffs ~ 15 minutes


Catalog Number 

CE/IVD catalog #: DC-10-1072
 Research-use-only (RUO) catalog #: DC-10-1072R

Pack Size

30 samples

Detected Codons

Codons 542, 545 and 1047

Intended Use

For In vitro diagnostic Use (CE/IVD) or for research use

Sample Type

Plasma and FFPE

Input DNA


Validated Instruments

Roche LightCycler® 480, Bio-Rad CFX384 and ABI QuantStudio 5

Detection Channel


Detection Chemistry


Turnaround Time

Less than 4 hours


Stable for 12 months at -25 ℃ to -15 ℃

Most frequent PIK3CA mutations detected by QClamp® PIK3CA Mutation Detection Test

ExonAmino Acid ChangeNucleotide ChangeCosmic No.



Ordering Information

For products that are in stock, DiaCarta will arrange shipment in 1-3 days. For products that are on backorder, DiaCarta will arrange shipment in 3-5 weeks.
Intended Use: QClamp® PIK3CA Mutation Detection Test is CE/IVD-certified. For the outside USA, this product is available for diagnostic use (CE/IVD) and research use (RUO). For the USA, this product is provided for research use only (RUO) and not for diagnostic use. DiaCarta ships CE/IVD version to the outside USA and ships RUO version to the USA. Please call 1-800-246-8878 or email order@diacarta.com if you have questions or specific needs.
Shipping Condition: QClamp® PIK3CA Mutation Detection Test will be shipped with dry ice. For domestic shipment, DiaCarta provides overnight delivery through FedEx Domestic Overnight Shipping Service. For international shipment, DiaCarta provides 3-7 days in transit through FedEx International Priority Shipping Service. Please contact DiaCarta if you prefer to use your own shipping carrier.

Need Help?

Call us: +1 (800) 878-6662

Email us: information@diacarta.com

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