Ordering Recommendation

Use to identify TP53 mutations in formalin-fixed, paraffin-embedded (FFPE) tissue from various tumors. TP53 mutation status is a prognostic biomarker in many tumor types, including lymphoid malignancies.

New York DOH Approval Status

Testing is not New York state approved. Specimens from New York clients will be sent out to a New York state-approved laboratory.

Specimen Required

Patient Preparation
Collect

Tumor tissue.
New York State Clients: Paraffin-embedded tissue.

Specimen Preparation

Formalin-fixed (10 percent neutral buffered formalin) and paraffin-embedded tissue.
Diff-Quik- and Papanicolaou-stained cytology smears are also acceptable. Number of slides needed for testing is dependent on the tumor cellularity of the smear. Slide(s) will be destroyed during testing process and will not be returned to client. Protect from excessive heat. Transport block and/or slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at 800-522-2787.
Resections: Transport 8 unstained 5-micron slides. (Min: 5 slides)
Small Biopsies: Transport 15 unstained 5-micron slides. (Min: 10 slides)

New York State Clients: Submit 7-10 unstained slides cut at 10 microns thick.

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

New York State Clients: Refrigerated. Also acceptable: Room temperature.

Unacceptable Conditions

Less than 10 percent tumor. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens processed in a non-EDTA decalcifier. FNA smears with less than 50 tumor cells.

Remarks

Include surgical pathology report.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block") or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Methodology

Qualitative Massively Parallel Sequencing

Performed

Varies

Reported

12-14 days

Reference Interval

Interpretive Data

Refer to report.

Compliance Category

Note

Gene Tested: TP53 (NM_000546.5) exons 2-11

Hotline History

N/A

CPT Codes

81351, 81352

Components

Component Test Code* Component Chart Name LOINC
2002148 Block ID 57723-9
3017689 TP53 FFPE Interp 103680-5
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

Somatic TP53 Mutations in Formalin-Fixed, Paraffin-Embedded (FFPE) Tissue