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Biocare Medical/CK HMW + p63 + AMACR (RM)/API 3154 DS AA/6-0-ml

Highmolecularweightcytokeratinsareexpressedinavarietyofnormalandneoplasticepithelialtissues(1).Inprostate,CKHMW[34βE12]hasbeenshowntobeausefulMarkerofbasalcellsofnormalglandsandprostaticintraepithelialneoplasia(PIN),aprecursorlesiontoprostaticadenocarcinoma;whereasinvasiveprostaticadenocarcinomatypicallylacksabasalcelllayer(2-4).

p63,ahomologofthetumorsuppressorp53,hasbeenidentifiedinproliferatingbasalcellsintheepitheliallayersofavarietyoftissues,includingepidermis,cervix,urotheliumandprostate(5).p63wasdetectedinnucleiofthebasalepitheliuminnormalprostateglands;however,itwasnotexpressedinmalignanttumorsoftheprostate(6).

α-MethylacylcoenzymeAracemase(AMACR),alsoknownasP504S,isaperoxisomalandmitochondrialenzymethatplaysaroleinbileacidsynthesisandβ-oxidationofbranchedchainfattyacids(7).AMACRwasinitiallyidentifiedfromaCDNAlibraryasagenethatisoverexpressedinhumanprostatecancer;withlittleornoexpressioninnormalprostate(8,9).Inimmunohistochemistry,AMACRhasbeenshowntobeaspecificmarkerofprostaticadenocarcinoma(8-11).Additionally,prostateglandsinvolvedinPINhavebeenfoundtoexpressAMACR,whereasAMACRwasnearlyundetectableinbenignglands(11,12).

StudieshaveshownthatcombinationsofCKHMW[34βE12],p63,and/orAMACRmaybeusefulintheevaluationofnormalprostateglands,PINandprostaticadenocarcinoma(13,14).

U.S.Patent8,603,765andpatentspending.

FormerlyknownasPIN-4®

IntendedUse

IVD

Source

MouseMonoclonal,RabbitMonoclonal

Clone

13H4,34BE12,4A4

Isotype

IgG,IgG1/kappa,IgG2a/kappa

Antigen

AMACR,CKHMW,p63

Localization

Cytoplasmic,Nuclear

PositiveControl

Normalprostateadenocarcinoma

SpeciesReactivity

Human;othersnottested

References:

1.MollR,etal.Thecatalogofhumancytokeratins:patternsofexpressioninnormalepithelia,tumorsandculturescells.Cell.1982Nov;31(1):11-24.
2.BostwickDG,QianJ.High-gradeprostaticintraepithelialneoplasia.ModPathol.2004Mar;17(3):360-79.
3.HumphreyPA.Diagnosisofadenocarcinomainprostateneedlebiopsytissue.JClinPathol.2007Jan;60(1):35-42.
4.ShahRB,etal.Comparisonofthebasalcell-specificmarkers,34betaE12andp63,inthediagnosisofprostatecancer.AmJSurgPathol.2002Sep;26(9):1161-8.
5.YangA,etal.p63,ap53homologat3q27–29,encodesmultipleproductswithtransactivating,death-inducing,anddominant-negativeactivities.MolCell.1998Sep;2(3):305-16.
6.SignorettiS,etal.p63isaprostatebasalcellmarkerandisrequiredforprostatedevelopment.AmJPathol.2000Dec;157(6):1769-75.
7.FerdinandusseS,etal.Subcellularlocalizationandphysiologicalroleofalphamethylacyl-CoAracemase.JLipidRes.2000Nov;41(11):1890-6.
8.XuJ,etal.Identificationofdifferentiallyexpressedgenesinhumanprostatecancerusingsubtractionandmicroarray.CancerRes.2000Mar15;60(6):1677-82.
9.RubinMA,etal.alpha-MethylacylcoenzymeAracemaseasatissuebiomarkerforprostatecancer.JAMA.2002Apr3;287(13):1662-70.
10.LuoJ,etal.Alpha-methylacyl-CoAracemase:anewmolecularmarkerforprostatecancer.CancerRes.2002Apr15;62(8):2220-6.
11.ZhouM,etal.Alpha-Methylacyl-CoAracemase:anoveltumormarkeroverexpressedinseveralhumancancersandtheirprecursorlesions.AmJSurgPathol.2002Jul;26(7):926-31.
12.WuCL,etal.Analysisofalpha-methylacyl-CoAracemase(P504S)expressioninhigh-gradeprostaticintraepithelialneoplasia.HumPathol.2004Aug;35(8):1008-13.
13.ShahRB,etal.Usefulnessofbasalcellcocktail(34betaE12+p63)inthediagnosisofatypicalprostateglandularproliferations.AmJClinPathol.2004Oct;122(4):517-23.
14.SungMT,etal.Alpha-methylacyl-CoAracemase(P504S)/34betaE12/p63triplecocktailstaininprostaticadenocarcinomaafterhormonaltherapy.HumPathol.2007Feb;38(2):332-41.
15.CenterforDiseaseControlManual.Guide:SafetyManagement,NO.CDC-22,Atlanta,GA.April30,1976“DecontaminationofLaboratorySinkDrainstoRemoveAzideSalts.”
16.ClinicalandLaboratoryStandardsInstitute(CLSI).ProtectionofLaboratoryWorkersfromOccupationallyAcquiredInfections;ApprovedGuideline-FourthEditionCLSIdocumentM29-A4Wayne,PA2014.

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