Template for Reporting Results of Biomarker Testing of Specimens From Patients With Carcinoma of the Breast

Abstract

he College of American Pathologists offers thesetemplates to assist pathologists in providing clinicallyuseful and relevant information when reporting results ofbiomarker testing. The College regards the reportingelements in the templates as important elements of thebiomarker test report, but the manner in which theseelements are reported is at the discretion of each specificpathologist, taking into account clinician preferences,institutional policies, and individual practice.The College developed these templates as educationaltools to assist pathologists in the useful reporting of relevantinformation. It did not issue them for use in litigation,reimbursement, or other contexts. Nevertheless, the Collegerecognizes that the templates might be used by hospitals,attorneys, payers, and others. The College cautions that useof the templates other than for their intended educationalpurpose may involve additional considerations that arebeyond the scope of this document.TEMPLATE FOR REPORTING RESULTS OF BIOMARKERTESTING OF SPECIMENS FROM PATIENTSWITH CARCINOMA OF THE BREASTCompletion of the template is the responsibility of thelaboratory performing the biomarker testingand/or providingthe interpretation. When both testing and interpretation areperformed elsewhere (eg, a reference laboratory), synopticreporting of the results by the laboratory submitting thetissue for testing is also encouraged to ensure that allinformation is included in the patient’s medical record andthus readily available to the treating clinical team.BIOMARKER REPORTING TEMPLATEBreastNote: Required elements in this template comply with the mostrecent versions of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines onHER2 and hormone receptor testing. Reporting elements arerequired only if applicable and only for tests performed. If somestudies were performed on different specimen(s), the specimennumber(s) should be provided.þ Data elements preceded by this symbol are not required.RESULTSEstrogen Receptor (ER)___ Positive (percentage of cells with nuclear positivity:___ %)þ Average intensity of staining:þ ___ Weakþ ___ Moderateþ ___ Strong___ Negative___ Internal controls present and ER positive (asexpected)___ Internal controls present but ER negative___ Internal controls absent___ Cannot be determined (explain): _________________Progesterone Receptor (PgR)___ Positive (percentage of cells with nuclear positivity:____ %)þ Average intensity of staining:þ ___ Weakþ ___ Moderateþ ___ Strong___ Negative___ Internal controls present and PgR positive (asexpected)___ Internal controls present but PgR negative