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Test Description Result Prognostic Interpretation GenPath ...

her2 scoring criteria update for breast CancerASCO/CAP has recently released revised scoring criteria for her2 analysis (FISH and IHC) for breast cancer . GenPath would like to advise you of the report changes we have made (see below) to reflect these her2 scoring changes. Revised her2 Guidelines available online through CAP. UpdateIf you have any questions please contact your local sales representativeThank YouFinal Report SMITH, SUSAN ONCOLOGY CENTER 123 MAIN STREET ELMWOOD PARK, NJ 07407 ACCT #: ABCDE 60 P: 555-555-5555 F: 555-555-5555 DOCTORPATIENTSAMPLESAMPLE, REPORT DOB: 11/19/1956 Age: 56Y Sex: F Surgical #: XXXXXXXX Patient ID: 55555555 Address: 123 MAIN STREET ANYTOWN, NJ 01451 Phone: (999) 999-9999 Specimen ID: 111111111 Date of Report: 10/12/2013 8:02 AM Date Collected: 10/07/2013 Time Unknown Date Received: 10/09/2013 Source: RIGHT breast Clinical Information: Right breast ReportDOCTORSAMPLE302 AUTOMATED breast cancer her2 /NEU FISH ANALYSISACCT #:31C0079 JAGGESSARSINGH, DANA F:(718) 661-7745P:(718) 670-1374 NYH/QUEENS PATHOLOGY 56-45 MAIN STREET FLUSHING, NY 11355C,#F56Y11/19/1956 DOB:Age:Sex:Patient ID:3799708 FIN, ALICE 223 18 56 RDAddress.

HER2 Scoring Criteria Update for Breast Cancer ASCO/CAP has recently released revised scoring criteria for HER2 analysis (FISH and IHC) for breast

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Transcription of Test Description Result Prognostic Interpretation GenPath ...

1 her2 scoring criteria update for breast CancerASCO/CAP has recently released revised scoring criteria for her2 analysis (FISH and IHC) for breast cancer . GenPath would like to advise you of the report changes we have made (see below) to reflect these her2 scoring changes. Revised her2 Guidelines available online through CAP. UpdateIf you have any questions please contact your local sales representativeThank YouFinal Report SMITH, SUSAN ONCOLOGY CENTER 123 MAIN STREET ELMWOOD PARK, NJ 07407 ACCT #: ABCDE 60 P: 555-555-5555 F: 555-555-5555 DOCTORPATIENTSAMPLESAMPLE, REPORT DOB: 11/19/1956 Age: 56Y Sex: F Surgical #: XXXXXXXX Patient ID: 55555555 Address: 123 MAIN STREET ANYTOWN, NJ 01451 Phone: (999) 999-9999 Specimen ID: 111111111 Date of Report: 10/12/2013 8:02 AM Date Collected: 10/07/2013 Time Unknown Date Received: 10/09/2013 Source: RIGHT breast Clinical Information: Right breast ReportDOCTORSAMPLE302 AUTOMATED breast cancer her2 /NEU FISH ANALYSISACCT #:31C0079 JAGGESSARSINGH, DANA F:(718) 661-7745P:(718) 670-1374 NYH/QUEENS PATHOLOGY 56-45 MAIN STREET FLUSHING, NY 11355C,#F56Y11/19/1956 DOB:Age:Sex:Patient ID:3799708 FIN, ALICE 223 18 56 RDAddress.

2 OAKLAND GARDENS, NY 11364 Phone:(718) 225-9190 Surgical #:S13-16145-1A Right breast carcinomaFixation time not provided. Specimen ID:302329051 Date of Report:10/17/2013 8:02 AMDate Collected:10/07/2013 Time UnknownDate Received:10/09/2013 Source:RIGHT BREASTC linical Information:Test DescriptionInterpretation and ResultsPhotomicrographNote relative predominance of red ( her2 ) signals compared to green (CEP-17) signals (x1000). her2 : CEP-17 ratio:Number of Cells Scanned:100 Average her2 CEP-17 FISH :1 HypodiploidMaximum her2 FISH results are best interpreted by analyzing the ratio with respect to the her2 /neu copy number. An H & E slide was reviewed and demonstrates lesional tissue. Analysis of her2 /neu gene amplification status was performed using an automated Fluorescence In Situ Hybridization (FISH) signal enumeration system (Metafer Slide Scanning System, MetaSystems Group Inc.)

3 , Watertown, MA). This system scans up to 5 different specified areas of tumor. A minimum of 20 cells representing >10% of contiguous and homogeneous invasive tumor cells were scanned. * Negative/Not Amplified: her2 /CEP17 ratio of < with an average her2 copy number of < signals/cell.* Equivocal/Borderline: her2 /CEP17 ratio of < with an average her2 copy number of and < signals/cell.* Positive/Amplified: her2 /CEP17 ratio of with an average her2 copy number of signals/cell, or her2 /CEP17 ratio of with an average her2 copy number of < signals/cell, or her2 /CEP17 ratio of < with an average her2 copy number of INFORMATIONREFERENCES2013 asco /CAP her2 Testing Guideline update : Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in breast cancer . Wolff, et al. Arch Pathol Lab Med. doi: her2 /neu DNA probe kit (Vysis) was used.

4 This test was developed and its performance characteristics determined by Vysis. It has been approved by the FDA to detect the over-expression of the HER-2/neu gene in neoplastic breast tissue. It may help identify candidates for Herceptin therapy. This lab has been approved by CLIA 88, designated as a high complexity laboratory and is qualified to perform these tests. Results are reported using the asco /CAP scoring 1 of 1 Liliya Feldman, 10/17/2013 8:21 AMElectronically signed by J. Weisberger, Laboratories, Edward H. Ross DriveElmwood Park, NJ 07407(800) 627-1479 James Weisberger, DirectorGenPath is a business unit of BioReference Laboratories, 10/12/2013481 Edward H Ross Drive Elmwood Park, NJ 07407 1 800 627 1479 tel 1 201 791 8760 fax GenPath is a business unit of BioReference Laboratories, Inc. 2013 BioReference Laboratories, Inc.

5 All rights reserved. 91643 11/13 FISH ReportFinal Report SMITH, SUSAN ONCOLOGY CENTER 123 MAIN STREET ELMWOOD PARK, NJ 07407 ACCT #: ABCDE 60 P: 555-555-5555 F: 555-555-5555 DOCTORPATIENTSAMPLESAMPLE, REPORT DOB: 11/19/1956 Age: 56Y Sex: F Surgical #: XXXXXXXX Patient ID: 55555555 Address: 123 MAIN STREET ANYTOWN, NJ 01451 Phone: (999) 999-9999 Specimen ID: 111111111 Date of Report: 10/12/2013 8:02 AM Date Collected: 10/07/2013 Time Unknown Date Received: 10/09/2013 Source: RIGHT breast Clinical Information: Right breast ReportDOCTORSAMPLE302 AUTOMATED breast cancer her2 /NEU FISH ANALYSISACCT #:31C0079 JAGGESSARSINGH, DANA F:(718) 661-7745P:(718) 670-1374 NYH/QUEENS PATHOLOGY 56-45 MAIN STREET FLUSHING, NY 11355C,#F56Y11/19/1956 DOB:Age:Sex:Patient ID:3799708 FIN, ALICE 223 18 56 RDAddress:OAKLAND GARDENS, NY 11364 Phone:(718) 225-9190 Surgical #.

6 S13-16145-1A Right breast carcinomaFixation time not provided. Specimen ID:302329051 Date of Report:10/17/2013 8:02 AMDate Collected:10/07/2013 Time UnknownDate Received:10/09/2013 Source:RIGHT BREASTC linical Information:Test DescriptionInterpretation and ResultsPhotomicrographNote relative predominance of red ( her2 ) signals compared to green (CEP-17) signals (x1000). her2 : CEP-17 ratio:Number of Cells Scanned:100 Average her2 CEP-17 FISH :1 HypodiploidMaximum her2 FISH results are best interpreted by analyzing the ratio with respect to the her2 /neu copy number. An H & E slide was reviewed and demonstrates lesional tissue. Analysis of her2 /neu gene amplification status was performed using an automated Fluorescence In Situ Hybridization (FISH) signal enumeration system (Metafer Slide Scanning System, MetaSystems Group Inc.)

7 , Watertown, MA). This system scans up to 5 different specified areas of tumor. A minimum of 20 cells representing >10% of contiguous and homogeneous invasive tumor cells were scanned. * Negative/Not Amplified: her2 /CEP17 ratio of < with an average her2 copy number of < signals/cell.* Equivocal/Borderline: her2 /CEP17 ratio of < with an average her2 copy number of and < signals/cell.* Positive/Amplified: her2 /CEP17 ratio of with an average her2 copy number of signals/cell, or her2 /CEP17 ratio of with an average her2 copy number of < signals/cell, or her2 /CEP17 ratio of < with an average her2 copy number of INFORMATIONREFERENCES2013 asco /CAP her2 Testing Guideline update : Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in breast cancer . Wolff, et al. Arch Pathol Lab Med. doi: her2 /neu DNA probe kit (Vysis) was used.

8 This test was developed and its performance characteristics determined by Vysis. It has been approved by the FDA to detect the over-expression of the HER-2/neu gene in neoplastic breast tissue. It may help identify candidates for Herceptin therapy. This lab has been approved by CLIA 88, designated as a high complexity laboratory and is qualified to perform these tests. Results are reported using the asco /CAP scoring 1 of 1 Liliya Feldman, 10/17/2013 8:21 AMElectronically signed by J. Weisberger, Laboratories, Edward H. Ross DriveElmwood Park, NJ 07407(800) 627-1479 James Weisberger, DirectorGenPath is a business unit of BioReference Laboratories, 10/12/2013 Final Report SMITH, SUSAN ONCOLOGY CENTER 123 MAIN STREET ELMWOOD PARK, NJ 07407 ACCT #: ABCDE 60 P: 555-555-5555 F: 555-555-5555 DOCTORPATIENTSAMPLESAMPLE, REPORT DOB: 6/13/1948 Age: 65Y Sex: F Surgical #: XXXXXXXX Patient ID: 55555555 Address: 123 MAIN STREET ANYTOWN, NJ 01451 Phone: (999) 999-9999 Specimen ID: 111111111 Date of Report: 10/21/2013 4:10 PM Date Collected: 10/16/2013 9:41 AM Date Received: 10/18/2013 Source: LEFT breast Clinical Information: Left breast calcificationsPATIENTF inal ReportDOCTORSAMPLE302 breast TUMOR Prognostic PROFILEACCT #:FXP6082 LLAUDES, MAXIMO F:(570) 476-3319P:(570) 476-3543 POCONO MEDICAL CENTER 206 EAST BROWN ST EAST STROUDSBURG, PA 18301%F65Y6/13/1948 DOB.

9 Age:Sex:Patient ID:34-44-21/PMS-13-8739-1 ROBERTS, CARROL 22 HIGHLAND CIRCLEA ddress:STROUDSBURG, PA 18360 Phone:(570) 982-4058 Surgical #:S13-8739-1 Left breast calcifications Specimen ID:302337523 Date of Report:10/21/2013 4:10 PMDate Collected:10/16/2013 9:41 AMDate Received:10/18/2013 Source:LEFT BREASTC linical Information:Test DescriptionResultPrognostic InterpretationEstrogen Receptor0%Negative1 Allred Score :0 Internal Control:PositiveExternal Control: Positive3 Progesterone Receptor<1%Negative1 Staining Intensity:WeakAllred Score :0 Internal Control:PositiveExternal Control: Positive3Ki-67 Proliferation Marker>10<20% PositiveBorderline1 her2 by IHC3+Positive2 Fixative Duration of Fixation (hours) Cold Ischemia Time (minutes) Sample AdequacyFormalinNot statedNot statedAdequateThe slides were scanned for morphometric analysis using BioImagene's Virtuoso and iScan scanner (BioImagene, Inc.)

10 , Cupertino, California). A negative control and a positive control for each antibody have been reviewed and or < 1% Negative>=1%PositiveER/PgR Interpretation <10%Favorable>10% & <20%Borderline>20%UnfavorableKi-67 InterpretationNo observable staining, or membrane staining that is incomplete and is faint/barely perceptible in 10% of invasive tumor membrane staining that is faint/barely perceptible in >10% of invasive tumor cells. 1+Circumferential membrane staining that is incomplete and/or weak/moderate in >10% of invasive tumor cells, or complete and circumferential intense membrane staining in 10% of invasive tumor cells. NegativeHER2 IHC InterpretationStaining PatternScoreAssessmentNegative2+3+Weakly Positive / EquivocalHomogeneous, dark, circumferential (chicken wire) pattern in >10% of invasive tumor IndexPloidy Interpretation1 DNA Aneuploid (Near-diploid)Cell Cycle by Flow Cytometry Aneuploid Aneuploid (Tetraploid)> Aneuploid Reference Ranges:DNA Index: Ploidy: Diploid<2%Low2%Intermediate>2%HighS-Phase in Infiltrating breast Tumors<3%Low3-6%Intermediate>6%High DNA Aneuploid DNA DiploidPATTERN ANALYSISPage 1 of 2R.

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