PIK3CA Mutation Analysis, Breast Cancer, IVD
Also known as: PIK3CA
Use
The therascreen PIK3CA RGQ RT-PCR Kit is a real-time, qualitative PCR assay for the detection of 11 mutations in the phosphatidyl 3-kinases catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue. The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY(R) (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue produce a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY® (alpelisib).
Special Instructions
Not provided.
Limitations
Results must be interpreted alongside all relevant clinical and laboratory findings and are not for standalone diagnostic use. Samples may harbor PIK3CA mutations not detected by the therascreen PIK3CA RGQ PCR Kit. Detection depends on sample integrity and DNA quantity. Procedures may require repetition if DNA quality is insufficient. This qualitative test does not measure Mutant Allele Frequency (MAF). Contamination precautions must be taken to prevent sample and reagent contamination. The therascreen PIK3CA RGQ PCR Kit is exclusively for DNA from FFPE breast cancer tissue using the QIAamp DSP DNA FFPE Tissue Kit.
Methodology
PCR-based (qPCR)
Biomarkers
LOINC Codes
- 60034-6 - PIK3CA gene Mut Anl Bld/T
- 57723-9 - Unique bar code # Current sample
- 8251-1 - Service Cmnt-Imp
- 49549-9 - Ref lab test method
- 75608-0 - Citation Ref Lab Test
- 72486-4 - Lab director name Provider
- 8100-0 - Specimen preparation
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
FFPE block or 6 unstained slides at 4-5m and one matching H&E-stained slide or 7 unstained slides
Minimum Volume
3 unstained slides at 4-5m and one matching H&E-stained slide or 4 unstained slides. Resection or Surgical Biopsies require > or =10% tumor content. Core Needle Biopsies require a minimum of > or = 20 mm2 tumor area total available for extraction.
Container
FFPE block or slides
Collection Instructions
Ship specimen at room temperature. Contact customer service at 800-345-4363 for questions regarding this test.
Storage Instructions
Maintain blocks/slides at room temperature.
Causes for Rejection
Specimens not meeting criteria for sample type, container, minimum volume, collection, and storage; specimens with suspicious foreign material; no tumor tissue in FFPE block or slides; broken or stained slides; non-formalin fixative.
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