The QClamp® PIK3CA Mutation Detection Test for plasma sample aids in the identification of cancer patients eligible for treatment and in monitoring response to therapy, which can lead to improved outcomes in cancer patients. The QClamp® PIK3CA Mutation Detection Test is an in vitro diagnostic real-time quantitative 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.
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 to similar assays available in the market due to robust 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
Reliably detects 0.1% to 0.5% VAF mutant DNA out of wild-type DNA for targeted mutations
Suitable for plasma and FFPE samples
LOW INPUT DNA
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 (Phosphoinositide 3-kinases or PI3-Kinases) are a 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 and 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 in colorectal cancer, breast and endometrial cancers, and other cancers, and are associated with poor prognosis. About 80 % of the point mutations reside in exon 9 and exon 20 and have been associated with resistance to cetuximab therapy in patients with colorectal cancer.
Streamlined Workflow for QClamp® Gene Mutation Detection Tests
Step 1: DNA Isolation & Quantification
Extract DNA from FFPE or plasma using a commercial DNA extraction kit and measure 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
CE/IVD catalog #: DC-10-1072
Research-use-only (RUO) catalog #: DC-10-1072R
Codons 542, 545 and 1047
Plasma and FFPE
Roche LightCycler® 480, Bio-Rad CFX384 and ABI QuantStudio 5
Less than 4 hours
Stable for 12 months at -25 ℃ to -15 ℃
Most frequent PIK3CA mutations detected by QClamp® PIK3CA Mutation Detection Test
|Exon||Amino Acid Change||Nucleotide Change||Cosmic No.|
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. Outside
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.