Breast Cancer Prognosis Profile II, Paraffin Block

CPT: 88360(x2); 88377
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Test Details

Test Includes

Estrogen/progesterone receptor (ER/PR) assay; HER-2/CEP17 FISH assay

Use

Provide prognostic information to aid the physician in determining risk of recurrence and potential benefits of therapy options for the breast cancer patient; HER-2/neu gene amplification status is a predictor of response to certain breast cancer treatments, including targeted immunotherapy.

Limitations

Use of fixatives other than 10% formalin may not yield equivalent or satisfactory results.

Methodology

ER/PR: immunohistochemistry; HER-2/neu gene amplification status: fluorescence in situ hybridization (FISH)

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tumor

Volume

One paraffin block

Container

Paraffin block transport pouch

Collection

Specimen should be fixed in 10% neutral-buffered formalin. Optimum fixation time is 12 to 24 hours, not to exceed 48 hours.

Storage Instructions

Maintain specimen at room temperature.

Clinical Information

Special Instructions

Please direct any questions regarding this test to oncology customer service at 800-345-4363.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
495036 Breast Ca Prog II, Paraffin 480278 Estrogen Receptor IHC % 14228-1
495036 Breast Ca Prog II, Paraffin 480279 Progesterone Rec. IHC % 14230-7
495036 Breast Ca Prog II, Paraffin 480276 Comment 8251-1
495036 Breast Ca Prog II, Paraffin 480268 Fixative N/A
495036 Breast Ca Prog II, Paraffin 480299 Fixation Time N/A
495036 Breast Ca Prog II, Paraffin 480298 Additional Information 19147-8
495036 Breast Ca Prog II, Paraffin 483249 HER-2/neu FISH 31150-6
495036 Breast Ca Prog II, Paraffin 483299 HER-2/CEP17 Ratio 49683-6
495036 Breast Ca Prog II, Paraffin 483328 Avg Num Her-2 signals/nucleus: 74860-8
495036 Breast Ca Prog II, Paraffin 483329 Avg Num CEP17 probes/nucleus: 74861-6
495036 Breast Ca Prog II, Paraffin 483332 Number of Tumor Cells Counted: 62361-1
495036 Breast Ca Prog II, Paraffin 483334 Number of Observers: N/A
495036 Breast Ca Prog II, Paraffin 483259 Fixation Time N/A
495036 Breast Ca Prog II, Paraffin 483260 Fixative N/A
495036 Breast Ca Prog II, Paraffin 483336 Scoring Criteria 19147-8
495036 Breast Ca Prog II, Paraffin 483002 Director Review N/A

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf