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Roche Diagnostics Corporation9115 Hague RoadIndianapolis, Indiana 46256diagnostics.roche.comRoche Tissue Diagnostics 2021 Roche MC-US-08482-0321Roche Tissue DiagnosticsEmpowering anatomic pathology labs to deliver accurate,timely results focused on improving patient careProduct Catalog 2021Product Catalog2021
Table of ContentsIntroductionRoche Tissue Diagnostics2-4Newest Additions5-8Medical ValuePersonalized Healthcare: Companion Diagnostics10-11Regulatory Classifications12-13Staining and Detection ReagentsIHC/ISH Reagents by Disease State18-23Primary Antibodies24-109IHC/ISH Detection111-116Special Staining Kits117-128Systems and SoftwareH&E Staining130-132IHC/ISH Automation133-134Special Stains135-136IHC/ISH Research137Digital Pathology Research138Workflow Solutions139-140Customer ExperienceWorkflow Consulting142Roche Diagnostics University143Roche Support Network144CareGiver Remote Support145Reimbursement146Medical and Scientific Affairs147AppendicesIndexTrademarks and Disclaimers150-157158
ROCHE TISSUE DIAGNOSTICSFounded by a pathologist, with a focus on innovationsthat change the practice of medicine
INTRODUCTIONRoche DiagnosticsInnovating diagnostics, shaping healthcare,changing livesRoche is a global pioneer in pharmaceuticals anddiagnostics, focused on advancing science to improvepeople’s lives. This combination of strengths has madeRoche the leader in personalized healthcare—a strategythat aims to fit the right treatment to each patient inthe best way possible.Combined strengths of the Roche GroupPharmaceuticalsThe world’s largest biotech company, Roche is also theglobal leader in in vitro diagnostics and tissue-basedcancer diagnostics.Personalized HealthcareSpanning the entire spectrum of diagnostics users2Diagnostics
INTRODUCTIONRoche Tissue DiagnosticsSolutions to help your lab advance patient careLike you, we’re passionate about the patient behindevery slide. We’re committed to transforming cancerdiagnosis with solutions that address the needs ofanatomic pathology labs and healthcare professionalsto help them improve the lives of the patients they serve.Empowering your lab from sample accessioningthrough case sign-outOur broad portfolio includes VENTANA integratedstaining and workflow management platforms, researchuse only (RUO) digital pathology solutions and a robustmenu of analytical and predictive assays that help labsincrease efficiency and deliver medical value.From the time a patient specimen arrives to delivery oftest results, Roche solutions enable your lab to provideaccurate and reliable results in a timely manner. Thishelps patients get the right test, for the right treatment,at the right time.Pathologist founded, patient focusedBuilding on the vision of Dr. Thomas Grogan,Roche continues to drive tissue diagnosticsinnovation that transforms the practice ofmedicine to improve patients’ lives.3
NEWEST ADDITIONSRoche Tissue DiagnosticsPartnering with healthcare professionals to improve patients’ lives.INNOVATIVE PORTFOLIO ofhigh-quality products that:Healthcare professionals gainDIAGNOSTIC CONFIDENCEIMPROVED PATIENT CAREresulting from:from: H elp healthcare professionalsdeliver personalized healthcarethat improves patients’ lives Comprise the industry’s largest menuof unique, medical-value assays todiagnose more disease states L everage extensive research andpharmaceutical collaborations4 I ndustry-leading quality and fullyautomated efficiency U nparalleled service and support,when and where you need it P roactive, comprehensive education Precision diagnoses that drive moreeffective treatments Faster, safer tissue-based diagnosisresulting from standardized,automated assays Broad menu of key biomarkers tohelp inform personalized healthcare
NEWEST ADDITIONSNewest AdditionsImproving lives through ongoing innovationAs part of Roche, we’re continuously investing in diagnostic tools that address unmetmedical needs and provide information to help advance patient care.CINtec PLUS CytologyKnow now if she is progressing towards cervical cancer In the fight against cervical cancer, the ability to identify disease early and with certainty through screening iscrucial to help better manage patients. While the addition of human papillomavirus (HPV) testing has enabledclinicians to identify women who are positive for HPV, which causes 99% of cervical cancers, challenges still remainin determining who is most at risk and will benefit from more immediate followup and who is at low risk and can begiven more time to clear the infection on her own.CINtec PLUS Cytology is the first FDA-approved test designed to address the need for a triage test that can moreclearly stratify disease risk in HPV-positive women. CINtec PLUS Cytology uses dual-stain technology to objectivelydetect the simultaneous presence within a single cell of two biomarkers, p16 and Ki-67, which indicates cellsundergoing oncogenic transformation. With more definitive information, clinicians can have the confidence andclarity needed to determine the right next step for their patients. Approved for triage of cobas HPV-positive/NILM* Pap cytology co-testing results in women ages 30-65 years Approved for triage of cobas HPV-positive results (HPV Primary Screening) in women ages 25-65 years Optimized for use on the fully automated VENTANA BenchMark ULTRA instrument Learn more at go.roche.com/cervicalsolutionsPack Size100 testsCatalog Number07478496001Alt. Cat. Nr.760-100Kit includes DAB and Fast Red detection chemistries.* NILM: negative for intraepithelial lesion or malignancySee complete product details on page 48.Co-expression of p16/Ki-67 biomarkers indicates transforming HPV infectionsCINtec PLUS CytologyPap Cytology-- Expression of p16 (brown)signals halting of celldivisionExpression of Ki-67 (red)signals progression of celldivisionCo-expression of p16 andKi-67 (brown and red)indicates cell cyclederegulationReliant on interpretation ofmorphology5
NEWEST ADDITIONSVENTANA HER2 DUAL ISH DNA Probe Cocktail ENTANA HER2 Dual ISH DNA Probe Cocktail assay is the next generationVof the INFORM HER2 Dual ISH assay. Based on input from customers, thisenhanced assay provides the same proven, fully automated brightfield technology,now optimized with oligo probes that produce faster hybridization and turnaroundtimes, delivering high reproducibility and decreased speckling. The VENTANAHER2 Dual ISH assay is used for determining HER2 gene amplification andhelps identify breast cancer patients eligible for treatment with HERCEPTIN (trastuzumab).Learn more at: go.roche.com/H2DIPack Size30 testsCatalog Number08314365001Alt. Cat. Nr.760-6072VENTANA ROS1 (SP384) Rabbit Monoclonal Primary AntibodyVENTANA ROS1 (SP384) is the first ROS1 immunohistochemistry (IHC)IVD product available to detect the presence of ROS1 protein expression innon-small cell lung cancer (NSCLC). Given the rarity of ROS1 rearrangements,use of an immunohistochemistry assay to detect the presence of ROS1 proteinexpression prior to confirmatory testing may decrease the overall cost of ROS1testing and will satisfy current professional testing guidelines. Learn more at: go.roche.com/lung cancerPack Size50 testsCatalog Number08404160001Alt. Cat. Nr.790-6087See complete product details on page 99.VENTANA pan-TRK (EPR17341) AssayVENTANA pan-TRK (EPR17341) is intended for the immunohistochemicaldetection of the C-terminal region of the tropomyosin receptor kinase (TRK)proteins A, B, and C, which is known to be conserved across wild-type andchimeric fusion proteins. Neurotrophic tyrosine receptor kinase (NTRK) genefusions are emerging as actionable biomarkers around a broad range oftumor types. Pan-TRK immunohistochemistry (IHC) has been shown to be aresource-efficient method to stratify patients for NTRK fusion genetic testing.Learn more at: go.roche.com/NTRKIHCPack Size50 testsCatalog Number08494665001Alt. Cat. Nr.790-7026See complete product details on page 91.6
NEWEST ADDITIONSVENTANA CLDN18 (43-14A) AssayVENTANA CLDN18 (43-14A) assay is a mouse monoclonal antibody producedagainst CLDN18 proteins and detects both CLDN18.1 and CLDN18.2 isoforms.Isoforms of CLDN18 can be detected in differentiated epithelial cells of the normalgastric mucosa and pneumocytes in normal lung tissue, in a variety of advancedand metastatic gastrointestinal cancers, including gastric, esophageal, pancreatic,biliary duct cancers, and in non-small cell lung cancer.Pack Size50 testsCatalog Number08504148001Alt. Cat. Nr.790-7027See complete product details on page 49.PAX-8 (EP331) Rabbit Monoclonal Antibody PAX-8 (EP331) is intended for use in the detection of the PAX-8 protein andis useful for marking several types of carcinoma included but not limited toovarian serous carcinoma, clear cell renal cell carcinoma, and papillary thyroidcarcinoma PAX-8 (EP331) is a sensitive and specific marker for both primaryand metastatic tumors.Pack Size50 testsCatalog Number08313431001Alt. Cat. Nr.760-6077See complete product details on page 92.Anti-CD117 (EP10) Rabbit Monoclonal Primary AntibodyAnti-CD117 (EP10) is a new Class 1 IVD antibody used to evaluate theexpression of CD117 protein. Along with a panel of antibodies, CD117 IHC mayaid in the diagnosis of a range of diseases, including gastrointestinal stromaltumors (GIST), mast cell disorders, and germ cell neoplasms. This new reagentwill replace the current Class III PATHWAY anti-c-KIT (9.7) primary antibody,allowing for broader use that will suit the current clinical application of CD117.Learn more at: go.roche.com/cd117Pack Size50 testsCatalog Number08763909001Alt. Cat. Nr.790-7061See complete product details on page 46.SATB2 (EP281) Rabbit Monoclonal Primary AntibodySATB2 (EP281) is an in vitro diagnostic assay with favorable sensitivity andspecificity for colorectal carcnomas when utilized in the immunohistochemicalpanel with cytokeratin 7 and cytokeratin 20. The sensitivity and specificity ofSATB2 for colorectal cancers make it a valuable antibody for differentiatingcarcinomas of unknown primaries.Pack Size50 testsCatalog Number08313415001Alt. Cat. Nr.760-6075See complete product details on page 100.7
NEWEST ADDITIONSRoche uPath Enterprise SoftwareCase management and collaboration with a 360 sample viewRoche uPath enterprise software enhances theefficiency of pathology laboratory workflow withconnectivity and automation. Integrating powerful imagingand analysis tools, the universal platform seamlesslyenables communication between pathologists andtechnicians via usability, innovation and digitization.Streamline case management: Featuring aninnovative design, the software enables multi-slidecanvas viewing for faster case loading, annotationand signout.Quickly access information: The intuitive webbased application offers safe, secure automateddata transfer so you can view all slides and caseinformation simultaneously.Improve patient care: Timely, efficient access toslide images enables case sharing and real-timecollaboration/remote consultation, with faster turnaround for second opinions.Customize your workflow: The software’s highlyconfigurable interface and scalability offerpersonalization to suit your needs.Fully integrated Connects with VANTAGE workflow solution†and VENTANA Connect middleware solution†for LIS interaction and data automation.† For information about the VENTANA DP 200slide scanner, VANTAGE workflow solution, andVENTANA Connect middleware solution, seepages 138 - 140.Intended Use: Roche uPath enterprise software is FDAcleared for specific clinical applications and is intendedfor research and educational use for other applications.Roche uPath enterprise software is not approved by theFDA for primary diagnosis.F or more information about Roche uPath enterprisesoftware and image analysis algorithms, visitgo.roche.com/uPathuPath digital pathology imageanalysis algorithmsEmpowering precision diagnosisIn combination with the VENTANA DP 200* slidescanner and Roche uPath enterprise software*,uPath image analysis algorithms* empowerpathologists to confidently, accurately andobjectively assess whole tissue slide images. Actionable: Objective and accurate assessmentof VENTANA DP 200 slide images that areactionable and reproducible. Integrated: Quick, one-click image analysisseamlessly integrated into Roche uPathenterprise software. Ready to Use: Fully trained and validated byexpert pathologists on Roche Tissue Diagnosticsbiomarkers.Current Menu: uPath PD-L1 (SP263) image analysis fornon-small cell lung cancer (NSCLC)* uPath HER2 (4B5) image analysis forbreast cancer* uPath HER2 Dual ISH image analysis forbreast cancer** For Research Use Only. Not for use in diagnosticprocedures.8
MEDICAL VALUEPioneering solutionsthat drive personalized healthcare
M E D I C A L VA L U EPersonalized Healthcare:Companion DiagnosticsBecause your assay choice mattersA call to personalize the practice of medicineOur commitment to helping you deliverpersonalized healthcare“ Personalized healthcare is not holding apatient’s hand. It’s holding the intimate detailsof a patient’s test results to a brighter lightand asking, ‘What am I missing?’”In our mission to improve the lives of all patientsafflicted with cancer, our goal is to empower you withthe highest quality, most innovative tools to help deliveron the promise of personalized diagnostics and treatment. We’re committed to accelerating the developmentof new cancer tests that can help improve and extendpatients’ lives by spanning the gap between genericand personalized treatment.— Tom Grogan, M.D.,pathologist and founder ofVentana Medical Systems, Inc.Linking the most accurate diagnosis with the mosttargeted and relevant therapeutic is the essence ofpersonalized healthcare, offering the potential for morepositive outcomes for the patient—saving lives andimproving the quality of life.“ Targeted diagnostic tests that help to improvemedical decision-making not only offer clinicalbenefits for patients but are also attractivethrough health economic benefits to regulatoryauthorities and payers.”— Severin Schwan,CEO, Roche10
M E D I C A L VA L U EVENTANA companion diagnosticsSelective and predictive assays essential for personalized healthcareVENTANA companion diagnostics are fully automated to help improve quality and standardize testing,and can easily fit into your current workflow.PATHWAY anti-HER-2/neu (4B5) RabbitMonoclonal Primary AntibodyThe most widely adopted HER2-IHC primary antibody,this FDA-approved assay consistently achieves highproficiency assessment scores compared to otherclones.† The assay aids in the assessment of breastcancer patients for whom HERCEPTIN (trastuzumab)treatment is considered.For more information, see page 70.VENTANA HER2 Dual ISH DNA Probe CocktailFDA-approved, fully automated, ready-to-use assay thatallows evaluation of HER2 gene status with morphologicalcontext using brightfield microscopy. The assay helpsidentify breast cancer patients eligible for treatment withHERCEPTIN (trastuzumab).Catalog Number: 08314365001Alternative Catalog Number: 760-6072VENTANA ALK (D5F3) CDx AssayFully automated, easy-to-score, 4½-hour ALK IHC testthat provides same-day results to aid in identifyingALK-positive non-small cell lung cancer (NSCLC)patients eligible for treatment with XALKORI (crizotinib),ZYKADIA (ceritinib), ALECENSA (alectinib) orLORBRENA (lorlatinib).For more information, see page 25.VENTANA PD-L1 (SP142) AssayFDA-approved, fully automated, ready-to-use assayfor determining PD-L1 status. The assay helps identifynon-small cell lung cancer (NSCLC) and triple-negativebreast cancer (TNBC) patients eligible for treatmentwith TECENTRIQ (atezolizumab).For more information, see page 93.†B ased on data from a leading external quality assessment scheme.Retrieved from http://www.nordiqc.org/epitope.php11
M E D I C A L VA L U ERegulatory ClassificationsWhat do they mean?At Roche Diagnostics, we develop and manufacture avariety of in vitro diagnostic (IVD) products, includingreagents, instruments and systems. IVDs that areclassified as a medical device for clinical diagnosticsfall under FDA regulations.In vitro diagnostic products are those reagents,instruments, and systems intended for use in thediagnosis of disease or other conditions, including adetermination of the state of health, in order to cure,mitigate, treat, or prevent disease or its consequences.Such products are intended for use in the collection,preparation, and examination of specimens takenfrom the human body.†IVD Assay Classifications:Risk to Public HealthNon-clinical reagents include: Research Use Only (RUO) Investigational Use Only (IUO) - Used only inclinical trials and not commercially marketedIn vitro diagnostic (IVD) productsRegulatory ClassificationFDA-regulated in vitro diagnostics are composedof non-clinical and clinical-use reagentsIRUOs and IUOs are not intended for clinicaldiagnostic use.Clinical reagents include: Class I, including analyte specific reagents (ASRs) Class II (510(k) and de novo status) Class III (Premarket Approval (PMA), companionand complementary status)FDA Cleared510(k) / de novo IIFDA Approved / PMA IIILowModerateHighClinical UtilityAdjuvant testStandalone assayPredictive / SelectiveDiagnosticCharacteristicsEstablished in literatureWell-characterizedtissue controlsClaims supported by clinicaltrials data submissionCD3ER, PR (breast),CINtec Histology,MMR IHC PanelHER2, ALK, PD-L1ExamplesAs device class increases from Class I to Class III, the regulatory controls also increase, with Class I devices subject tothe least regulatory control, and Class III devices subject to the most stringent regulatory control.† #112
M E D I C A L VA L U EThe regulatory controls for each device classinclude: Class II (moderate to high risk): General controlsand special controls RUO/IUO (Research Use Only/InvestigationalUse Only)— Class ll products are standalone, moderate-riskassays, requiring greater regulatory controlsto provide reasonable assurance of safety andeffectiveness.— RUO and IUO devices are not intended forclinical diagnostic use. Class III (high risk): General controls andPremarket Approval (PMA) Class I (low to moderate risk): General controls— Class l devices are typically an adjuvant test, lowrisk and therefore subject to the least regulatorycontrols.RUOClass I *Class IIClass IIIFDA submissionNoNoYesPMAImmunoreactivity (ToT oYesYesYesPre-analytical (fixatives, etc)NoYesOccasionallyYesStability studiesNoYesYesYesDesign validationNoYesYesYesReader precisionNoNoYesYesInter-laboratory reproducibility or repeatabilityNoNoYesYesProof of utility in detecting a diseaseNoNoOccasionallyYesClinical utility proving device performance inrelation to drug outcome or potential misdiagnosisNoNoOccasionallyYesCut offNoNoYesYesNoneBiomarkerdetectionAids intreatmentdecisionsLinked to atherapy(Companion/Complementary)Product Classification:Characterization studies performed— Class lll products are used as predictive orselective diagnostic assays, and have the highestrisk. They are therefore subject to the highestlevel of regulatory control. These devices mustbe approved by the FDA prior to being promotedor sold in the U.S.Clinical application:* Registered with the FDA13
14M E D I C A L VA L U E
PRIMARY ANTIBODIESA vast product portfolio supported by the resources andglobal reach of a leading healthcare company
PRIMARY ANTIBODIESReady-to-Use Primary AntibodiesMore than 300 prediluted antibodies, optimizedfor use on VENTANA staining platformsFeaturing a world-class breast panel as well as cornerstone and emerging markers for lung diagnostics andother disease states, our comprehensive portfolio ofhigh-value assays empowers pathology labs to deliveraccurate, timely results with clinical confidence.Breast ER (SP1) PR (1E2) HER-2/neu (4B5) Ki-67 (30-9) p53 (DO-7) HER2 Dual ISH I mprove testing efficiency: Our predilutedantibodies are optimized for use on the fullyautomated VENTANA BenchMark staining platforms,reducing time-to-result and the resources requiredwith manual or semi-automated solutions.Lung TTF-1 (SP141) Cytokeratin 5/6 (D5/16B4) Napsin A (MRQ-60) p40 (BC28) ALK (D5F3) ROS1 (SP384) ount on consistent performance: Roche Cantibodies have consistently demonstrated(via in-house validation) superior performancewhen compared to concentrated antibodiesthat require manual dilution.1 C hoose from a comprehensive portfolio:We offer more than 300 ready-to-use Class I assays,including the largest menu of rabbit monoclonalIVD antibodies available. DLL3 (SP347) pan-TRK (EPR17341)Colorectal MLH-1 (M1) MSH2 (G219-1129) MSH6 (SP93) PMS2 (A16-4) BRAF-V600E (VE1) CDX-2 (EPR2764Y) CLDN18 (43-14A) SATB2 (EP281)Our broad portfolio includes sensitive, specific assaysfor key markers. Turn the page for a complete listing ofour primary antibodies and other IHC/ISH reagents bydisease state.16PRIM
PRIMARY ANTIBODIESMARY The rabbit monoclonal differenceSuperior sensitivity and specificity forconsistent, high-quality staining 2Demonstrating a better signal-to-noise ratio comparedto mouse monoclonal and rabbit polyclonal antibodies,A N TrabbitI B O monoclonals:D-IES Provide broader diagnostic potential due torecognizing antigens and epitopes thatare not immunogenic in rodents Reduce background for cleaner slides Provide greater consistency from lot to lotReferences:1. Assessment Run B13 2012. Estrogen receptor (ER).NordiQC. sessment-B13-ER.htm. Updated July 10,2012. Accessed May 23, 2013.2. Spieker-Polet H, Sethupathi P, Yam PC, Knight KL.Rabbit monoclonal antibodies: Generating a fusionpartner to produce rabbit-rabbit hybridomas.Proc Natl Acad Sci U S A. 1995; 92(20):9348-9352.17
PRIMARY ANTIBODIESIHC/ISH Reagents by Disease StateExtensive menu of ready-to-use clinical reagents, optimized foruse on VENTANA BenchMark IHC/ISH staining platformsBreastTypical Breast Panel Assays Estrogen Receptor (ER) (SP1), CONFIRMProgesterone Receptor (PR) (1E2), CONFIRMHER-2/neu (4B5), PATHWAYVENTANA HER2 Dual ISH DNA Probe CocktailKi-67 (30-9), CONFIRMp53 (DO-7), CONFIRME-cadherin (36), VENTANAFOXA1 (2F83)GATA3 (L50-823)Human Placental Lactogen (hPL) (polyclonal)p57 (Kp10)PAX-8 (EP331)PAX-8 (MRQ-50)PD-L1 (SP142) Assay, VENTANATopoisomerase IIα (JS5B4), CONFIRM18CervicalPRIMCINtec HistologyCINtec PLUS Cytology
PRIMARY ANTIBODIESLungMARY ANTIBODTypicalI E SLung Panel Assays Cytokeratin 5/6 (D5/16B4)Napsin A (MRQ-60)p40 (BC28)Thyroid Transcription Factor-1 (SP141)ALK (D5F3) CDx Assay, VENTANABG8, Lewisy (F3)CD56 (MRQ-42)CEA (CEA31)Chromogranin A (LK2H10)c-MET Total (SP44), CONFIRMCytokeratin 5 (SP27)Cytokeratin 5/14 (EP1601Y/LL002)Cytokeratin 7 (SP52), CONFIRMCytokeratin 14 (SP53)Cytokeratin 17 (SP95)Cytokeratin 20 (SP33), CONFIRMCytokeratin (CAM 5.2)Desmoglein 3 (5G11)E-cadherin (36), VENTANAE-cadherin (EP700Y)EGFR (3C6), CONFIRMEGFR (5B7), CONFIRMEGFR E746-A750 del (SP111)EGFR L858R (SP125)EMA (E29), CONFIRMEp-CAM (Epithelial Specific Antigen) (Ber-EP4)Epithelial-Related Antigen (MOC-31)Ki-67 (30-9), CONFIRMMesothelial Cell (HBME-1)MUC1 (H23)Napsin A (polyclonal)NSE (MRQ-55)p63 (4A4), VENTANAPan Keratin (AE1/AE3/PCK26)pan-TRK (EPR17341) Assay, VENTANAPD-L1 (SP142) Assay, VENTANAPD-L1 (SP263 ) Assay, VENTANAROS1 (SP384)SOX-2 (SP76)SOX-10 (SP267)Synaptophysin (MRQ-40)Synaptophysin (SP11), CONFIRMTAG-72 (B72.3)Thyroid Transcription Factor-1 (8G7G3/1), CONFIRMWT1 (6F-H2)The identified typical antibodies and panels listed for disease state stratification are for informational use only and no medicalvalue or intended use claims are being made. For that information, please refer to the specific product package insert.19
PRIMARY ANTIBODIESIHC/ISH Reagents by Disease State (continued)Colorectal and GastrointestinalTypical Colorectal Panel Assays MLH1 (M1), VENTANAMSH2 (G219-1129), VENTANAMSH6 (SP93), VENTANAPMS2 (A16-4), VENTANABRAF-V600E (VE1), VENTANATypical Gastrointestinal Panel Assays 20CD34 (QBEnd/10), CONFIRMCD117 (EP10)CDX-2 (EPR2764Y)CLDN18 (43-14A), VENTANACytokeratin 7 (SP52), CONFIRMCytokeratin 20 (SP33), CONFIRMDOG1 (SP31)Helicobacter pylori (SP48), VENTANASmooth Muscle Actin (1A4)Beta-catenin (14)Cadherin 17 (SP183)COX-2 (SP21)Cytokeratin 19 (A53-B/A2.26)Glutamine Synthetase (GS-6)MUC1 (H23)SATB2 (EP281)PRIM
PRIMARY ANTIBODIES DermatopathologyTypical Melanoma Panel Assays OMART-1/melanA (A103), CONFIRMMARY ANTIBD MelanomaAssociatedAntigen (KBA.62)IES Melanoma Associated Antigen (PNL2)Melanosome (HMB45), CONFIRMMITF (C5/D5), CONFIRMNerve Growth Factor Receptor (MRQ-21)S100 (4C4.9), CONFIRMS100 (polyclonal), CONFIRMSOX-10 (SP267)Tyrosinase (T311), CONFIRMA-1-Antichymotrypsin (ACT) (polyclonal)A-1-Antitrypsin (polyclonal)Albumin, FITC (polyclonal)C1q, FITC (polyclonal)C3, FITC (polyclonal)CD2 (MRQ-11)CD3 (2GV6), CONFIRMCD31 (JC70)CD34 (QBEnd/10), CONFIRMCD63 (NKI/C3)CEA (CEA31)Cytokeratin 8 & 18 (B22.1 & B23.1)Desmin (DE-R-11), CONFIRMEMA (E29), CONFIRMEp-CAM (Epithelial Specific Antigen) (Ber-EP4)Factor VIII Related Antigen (polyclonal)Factor XIIIa (AC-1A1)Fibrinogen, FITC (polyclonal)IgA (Immunoglobulin A) (polyclonal)IgA (Immunoglobulin A), FITC (polyclonal)IgG (Immunoglobulin G) (polyclonal)IgG (Immunoglobulin G), FITC (polyclonal)IgM (Immunoglobulin M) (polyclonal)IgM (Immunoglobulin M), FITC (polyclonal)Kappa, FITC (polyclonal)Keratin (34ßE12), CONFIRMLambda, FITC (polyclonal)Macrophage (HAM-56)Melanoma Triple Cocktail (A103, HMB45, T311)Neurofilament (2F11)p53 (Bp53-11)p53 (DO-7), CONFIRMPodoplanin (D2-40)Synaptophysin (MRQ-40)Synaptophysin (SP11), CONFIRMTryptase (G3)Vimentin (V9), CONFIRMThe identified typical antibodies and panels listed for disease state stratification are for informational use only and no medicalvalue or intended use claims are being made. For that information, please refer to the specific product package insert.21
PRIMARY ANTIBODIESIHC/ISH Reagents by Disease State (continued)HematopathologyTypical Hematopathology Panel Assays bcl-2 (SP66)c-Myc (Y69)CD3 (2GV6), CONFIRMCD5 (SP19), CONFIRMCD10 (SP67), VENTANACD20 (L26), CONFIRMCD23 (SP23), CONFIRMCD30 (Ber-H2)Cyclin D1 (SP4-R), VENTANAKi-67 (30-9), CONFIRMMUM1 (EP190)PAX5 (SP34), CONFIRMALK1 (ALK01), CONFIRMAnnexin A1 (MRQ-3)bcl-2 (124), CONFIRMbcl-6 (GI191E/A8)BOB.1 (SP92)BRAF V600E (VE1), VENTANACD1a (EP3622)CD2 (MRQ-11)CD4 (SP35), CONFIRMCD7 (SP94)CD8 (SP57), CONFIRM22CD13 (SP187)CD14 (EPR3653)CD15 (MMA), CONFIRMCD16 (SP175)CD25 (4C9)CD31 (JC70)CD33 (SP266)CD34 (QBEnd/10), CONFIRMCD38 (SP149)CD43 (L60)CD45 (LCA) (2B11 & PD7/26)CD45 (LCA) (RP2/18), CONFIRMCD45R (MB1)CD56 (123C3), CONFIRMCD56 (MRQ-42)CD57 (NK-1)CD61 (2f2)CD68 (KP-1), CONFIRMCD71 (MRQ-48)CD79a (SP18), CONFIRMCD99 (O13), CONFIRMCD138/syndecan-1 (B-A38)Fascin (55k-2)FoxP1 (SP133)Galectin-3 (9C4)Glycophorin A (GA-R2)Granzyme B (polyclonal)Hemoglobin A (SP212)PRIM
PRIMARY ANTIBODIESMARYProstateHGAL (MRQ-49)IgA (Immunoglobulin A) (polyclonal)D) (polyclonal)A N TIgDI B (ImmunoglobulinODIgG (ImmunoglobulinG) (polyclonal)IESIgM (Immunoglobulin M) (polyclonal)Kappa (polyclonal), CONFIRMLambda (polyclonal), CONFIRMLMO2 (SP51)Lysozyme (polyclonal)Myeloperoxidase (polyclonal)Oct-2 (MRQ-2)PD-1 (NAT-105)SOX-11 (MRQ-58)Spectrin (RBC2/3D5)T-bet (MRQ-46)TdT (polyclonal)TRAcP (9C5)ZAP-70 (2F3.2)Typical Prostate Panel Assays asal Cell Cocktail (34βE12 p63), VENTANABCytokeratin 5/6 (D5/16B4)p504s (SP116)p63 (4A4), VENTANAPSA (polyclonal), CONFIRMPSAP (PASE/4LJ)Androgen Receptor (SP107)Carbonic Anhydrase IX (EP161)Cytokeratin (35betaH11)Cytokeratin 7 (SP52), CONFIRMCytokeratin 20 (SP33), CONFIRMERG (EPR3864)NKX3.1 (EP356)PSA (ER-PR8)PSMA (EP192)PTEN (SP218), VENTANARenal Cell Carcinoma (PN-15)Uroplakin III (SP73)The identified typical antibodies and panels listed for disease state stratification are for informational use only and no medicalvalue or intended use claims are being made. For that information, please refer to the specific product package insert.23
PRIMARY ANTIBODIESA-1-Antichymotrypsin (polyclonal)Catalog Number:Alt. Cat. Nr.:Quantity:Controls:Clone Name:Species:Localization:Regulatory Status:05267196001760-260450 testsHistiocytic TumorsPolyclonalRabbitCytoplasmicIVDINTENDED USEA-1-Antichymotrypsin Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the alpha-1 antichymotrypsin protein informalin-fixed, paraffin-embedded tissue stained on VENTANA BenchMark IHC/ISH instruments. This product should be interpreted by a qualifiedpathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitrodiagnostic (IVD) use.A-1-Antitrypsin (polyclonal)Catalog Number:Alt. Cat. Nr.:Quantity:Controls:Clone Name:Species:Localization:Regulatory Status:05267200001760-260550 testsAppendix, Lymph Node, TonsilPolyclonalRabbitCytoplasmicIVDINTENDED USEA-1-Antitrypsin Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the A-1-Antitrypsin protein in formalin-fixed,paraffin-embedded tissue stained on VENTANA BenchMark IHC/ISH instruments. This product should be interpreted by a qualified pathologist inconjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.ACTH (polyclonal)Catalog Number:Alt. Cat. Nr.:Quantity:Controls:Clone Name:Species:Localization:Regulatory Status:05268176001760-270850 testsNormal PituitaryPolyclonalRabbitCytoplasmicIVDINTENDED USEACTH Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the ACTH protein in formalin-fixed, paraffin-embeddedt
Table of Contents Introduction Roche Tissue Diagnostics 2-4 Newest Additions 5-8 Medical Value Personalized Healthcare: Companion Diagnostics 10-11 Regulatory Classifications 12-13 Staining and Detection Reagents
