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Estrogen Receptor, Progesterone Receptor, and HER-2 Immunohistochemistry Testing

Estrogen Receptor, Progesterone Receptor, and HER-2 Immunohistochemistry Testing

Test Guide

Estrogen Receptor, Progesterone Receptor, and HER-2 Immunohistochemistry Testing

Quest Diagnostics has 4 options for estrogen receptor (ER), progesterone receptor (PR), and HER-2/neu immunohistochemistry (IHC) testing (Table 1). The traditional option includes antigen staining, analysis, and interpretation of results. For pathologists who want to analyze and interpret the stains themselves, a stain without interpretation option is available. For these 2 options, analysis of the stained tissue is performed manually. Since manual analysis of stained slides is time-consuming and subjective, semi-automated analysis is now an option. The InScape® line of testing incorporates semi-automated analysis performed at either Quest Diagnostics or the referral site.

The InScape immunohistochemistry system is comprised of 5 steps: 1) antigen-specific immunohistochemistry staining; 2) whole slide scanning to create a digital image of the entire stained tissue section; 3) manual selection of the regions to be analyzed, performed by a pathologist at Quest Diagnostics or at the referral site; 4) automated determination of results according to an antigen-specific computer algorithm; and 5) pathologist review and validation of the results either at Quest Diagnostics or the referral site. Digital images are available at the client/referral site within 24 hours. Studies contributing to FDA clearance of the hardware and software used are shown in Tables 2 and 3.

Table 1. Available Testing Options for ER, PR, and HER-2 Immunohistochemistrya

  Stain with Interpretation Stain without Interpretation

InScape® with Interpretation

InScape® without Interpretation

Clinical utility Assist with treatment selection; assess prognosis in patients with breast cancer
Method IHC IHC IHC IHC
Image analysis Manual,
microscopic
Manual,
microscopic
Computer-
assisted, digital
Computer-
assisted, digital
Digital image provided No No Yes Yes
Stained slides provided Yes
 
Yes Yes Yes
ER/PR results provided

Positive (1%) or negative (<1%) for tumor nuclei stainingb

Stain intensity (weak, moderate,
or strong)

None

Positive (1%) or negative (<1%) for tumor nuclei stainingb

Stain intensity (weak, moderate,
or strong)

None
HER-2 results provided Negative (0, 1+) equivocal (2+), or positive (3+) cell membrane stain intensity None Negative (0, 1+) equivocal (2+), or positive (3+) cell membrane stain intensity None

Reporting pathologistc

Quest Diagnostics pathologist Referring/client pathologist Quest Diagnostics pathologist Referring/client pathologist
Equipment required at
client site
None Microscope None

Image analysis and viewing softwared

a See Table 4 for available test codes.

b Cutpoint consistent with ASCO/CAP guidelines.1
c Responsible for software validation and quality control, both of which should be performed according to the institution’s standard operating procedures.
d To obtain, contact your Quest Diagnostics sales representative.

Table 2. Reproducibility of Manual and Automated Image Analysis2,3

ER PR

HER-2

  % Positive Nuclei Intensity Score   % Positive Nuclei Intensity Score   Score

Manual

Inter-pathologist

 

91% - 99%

 

55% - 86%

 

 

84% - 99%

 

59% - 88%

 

 

76% - 91%

Automated

Inter-pathologist

 

94% - 99%

 

89% - 90%

 

 

85% - 99%

 

69% - 88%

 

 

86% - 94%

Each of 3 pathologists selected, in a blinded manner, the tumor regions to be analyzed. Analysis was performed on 80 specimens for the ER studies and 180 specimens for the PR and HER-2 studies. Data represent the range of agreement in results obtained among the various pathologists (eg, pathologist 1 vs 2, 1 vs 3, and 2 vs 3).

Table 3. Percent Agreement Between Manual and Automated Image Analysis Results2,3
Percent Agreement

ER

% Positive Nuclei

Intensity Score

 

92 – 98

64 – 86

PR

% Positive Nuclei

Intensity Score

 

81 – 99
59 – 84

HER-2

78 – 92

Each of 3 pathologists selected, in a blinded manner, the tumor regions to be analyzed. Analysis was performed on 80 specimens for the ER studies and 180 specimens for the PR and HER-2 studies. The data represent the range of agreements obtained by the pathologists (ie, range derived from the agreement between manual and automated for each pathologist).

Table 4. Available Test Codes

Test Code

Test Name

36160X

Estrogen Receptor (ER), IHC with Interpretation

19197X

Estrogen Receptor (ER), IHC without Interpretation

36159X

Progesterone Receptor (PR), IHC with Interpretation

19261X

Progesterone Receptor (PR), IHC without Interpretation

30316

HER-2, IHC, with Interpretation

19214X

HER-2, IHC, without Interpretation

15547

HER-2 , IHC [with Interpretation] with Reflex to FISHa

7037X

ER/PR, Paraffin Block [IHC with Interpretation]

10970

ER/PR/HER-2 [IHC with Interpretation] with Reflex to HER-2 FISH, Paraffin Blocka

70183X

InScape® ER, Quantitative IHC with Interpretation

70175X

InScape® ER, Quantitative IHC without Interpretation

70176X

InScape® PR, Quantitative IHC with Interpretation

70178X

InScape® PR, Quantitative IHC without Interpretation

70179X

InScape® HER-2, Quantitative IHC with Interpretation

70181X

InScape® HER-2, Quantitative IHC without Interpretation

16708X

InScape® ER/PR, Quantitative IHC with Interpretation

16711X

InScape® ER/PR, Quantitative IHC without Interpretation

16706X

InScape® ER/PR/HER-2 Quantitative IHC with Interpretation

16707X

InScape® ER/PR/HER-2 Quantitative IHC without Interpretation

a Reflex tests are performed at an additional charge and are associated with an additional CPT code.

References

  1. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptor in Breast Cancer. J Clin Oncol. 2010;28:2784-2795.

  2. 510K summary of substantial equivalence: ScanScope® XT System [HER-2]. U.S. Food and Drug Administration Center for Devices and Radiological Health Web site. Available at: http://www.accessdata.fda.
    gov/cdrh_docs/pdf7/K071128.pdf
    . Published October 10, 2007. Accessed October 2, 2012.

  3. 510K summary of substantial equivalence: ScanScope® XT System [ER/PR]. U.S. Food and Drug Administration Center for Devices and Radiological Health Web site. Available at: http://www.accessdata.fda.
    gov/cdrh_docs/pdf7/K073677.pdf
    . Published August 11, 2008. Accessed October 2, 2012.
     

Content reviewed 12/2012
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* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.