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Test Code PIK3T PIK3CA Mutation Analysis, Tumor


Necessary Information


A pathology report (final or preliminary), at minimum containing the following information, must accompany specimen for testing to be performed:

1. Patient name

2. Block number-must be on all blocks, slides, and paperwork (can be handwritten on the paperwork)

3. Tissue collection date

4. Source of the tissue



Specimen Required


This assay requires at least 20% tumor nuclei.

-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue 108 mm(2)

-Minimum amount of tumor area: tissue 18 mm(2)

-These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei

-Tissue fixation: formalin-fixed paraffin-embedded (FFPE), non-decalcified

 

Preferred: Submit 2, if available, of the following specimens.

Acceptable: Submit at least one of the following specimens.

 

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.

 

Specimen Type: Tissue slide

Slides: 1 Hematoxylin and eosin-stained and 10 unstained

Collection Instructions:

Submit the followings slides:

1 Slide stained with hematoxylin and eosin

AND

10 Unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.

Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block.

Additional Information: Unused unstained slides will not be returned.


Secondary ID

614801

Useful For

Identification of hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer tumors that may be eligible for treatment with targeted kinase inhibitor therapy (eg, alpelisib).

Testing Algorithm

When this test is ordered, slide review will always be performed at an additional charge.

Method Name

Polymerase Chain Reaction (PCR)

Reporting Name

PIK3CA Mutation Analysis, Tumor

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred)
  Refrigerated 

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

An interpretive report will be provided

Day(s) Performed

Monday through Friday

Report Available

8 to 12 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

81309

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PIK3T PIK3CA Mutation Analysis, Tumor 60034-6

 

Result ID Test Result Name Result LOINC Value
616654 Result Summary 50397-9
616655 Result 82939-0
616656 Interpretation 69047-9
616657 Additional Information 48767-8
616658 Specimen 31208-2
616659 Source 31208-2
616660 Tissue ID 80398-1
616661 Released By 18771-6

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

Additional Tests

Test ID Reporting Name Available Separately Always Performed
SLIRV Slide Review in MG No, (Bill Only) Yes