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St. John Health System
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PIK3CA Mutation Analysis

Order Name PIK3CA Mutat
Test Number: 6907417
Revision Date 12/12/2022
Test Name Methodology LOINC Code
PIK3CA Mutation Analysis
Polymerase Chain Reaction/Sequencing 60034-6 
SPECIMEN REQUIREMENTS
Specimen Specimen Volume (min) Specimen Type Specimen Container Transport Environment
Preferred 1 Block Tissue Paraffin Block Room Temperature
Alternate 1 See Instructions Tissue See Instructions Room Temperature
Instructions Notes: 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. Minimum
Specimen Type: FFPE block or slides
Specimen Storage: Maintain blocks/slides at room temperature.
Specimen Collection: Ship specimen at room temperature. Please direct any questions regarding this test to customer service at 800-345-4363.
Special Instructions: Please provide a copy of the pathology report. Testing will be delayed if the pathology report is NOT received. Please direct any questions regarding this test to customer service at 800-345-4363.
Specimen Stability: Ambient: Not Available, Refrigerated : Not Available, Frozen: Not Available
GENERAL INFORMATION
Expected TAT 7 days from setup  
Clinical Use PIK3CA Mutation Analysis - PIK3CA mutation has been associated with poor prognosis in endometrial, breast and colorectal cancers. Mutations in exons 9 and 20 of PIK3CA ave also been associated with resistance to cetuximab therapy in patients with colorectal cancer. 
Notes The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR in vitro diagnostic test, performed on the Rotor-Gene Q MDx (US) instrument. It uses allele refractory mutation system (ARMS) primers, hydrolysis probes and PCR clamp technologies to detect 11 mutations in exons 7, 9 and 20 of the PIK3CA oncogene against a background of wild-type gDNA.
Labcorp Test Code: 485113
CPT Code(s) 88381, 0155U
Service Provided By Labcorp Oklahoma, Inc.
Lab Section Reference Lab