美国FDA认证COBAS-HPV-作为宫颈癌筛查首选方案

FDAapprovesfirsthumanpapillomavirustestforprimarycervicalcancerscreeningFDANEWSRELEASEForImmediateRelease:April24,2014MediaInquiries:SusanLaine,301-796-5349,[e-mail]:888-INFO-FDATheU.S.FoodandDrugAdministrationtodayapprovedthefirstFDA-approvedHPVDNAtestforwomen25andolderthatcanbeusedalonetohelpahealthcareprofessionalassesstheneedforawomantoundergoadditionaldiagnostictestingforcervicalcancer.Thetestalsocanprovideinformationaboutthepatient’sriskfordevelopingcervicalcancerinthefuture.Usingasampleofcervicalcells,thecobasHPVTestdetectsDNAfrom14high-riskHPVtypes.ThetestspecificallyidentifiesHPV16andHPV18,whileconcurrentlydetecting12othertypesofhigh-riskHPVs.BasedonresultsofthecobasHPVTest,womenwhotestpositiveforHPV16orHPV18shouldhaveacolposcopy,anexamusingadevicethatilluminatesandmagnifiesthecervixsoaphysiciancandirectlyobservethecervicalcells.Womentestingpositiveforoneormoreofthe12otherhigh-riskHPVtypesshouldhaveaPaptesttodeterminetheneedforacolposcopy.HealthcareprofessionalsshouldusethecobasHPVTestresultstogetherwithotherinformation,suchasthepatientscreeninghistoryandriskfactors,andcurrentprofessionalguidelines.“Today’sapprovalofferswomenandphysiciansanewoptionforcervicalcancerscreening,”saidAlbertoGutierrez,Ph.D.,directoroftheOfficeofInVitroDiagnosticsandRadiologicalHealthattheFDA’sCenterforDevicesandRadiologicalHealth.“RocheDiagnosticsconductedawell-designedstudythatprovidedtheFDAwithareasonableassuranceofthesafetyandeffectivenesswhenusedasaprimaryscreeningtoolforcervicalcancer.”TheFDAfirstapprovedthetest,calledthecobasHPVTestin2011foruseinconjunctionwithorasafollow-uptoaPaptest(cellcytology),whichexaminescervicalcellsforchangesthatmightbecomecervicalcancer.Today’sapprovalexpandstheuseofthetesttoincludeuseaseitheraco-testorasaprimarycervicalcancerscreeningtest,however;itdoesnotchangecurrentmedicalpracticeguidelinesforcervicalcancerscreening.Theseguidelinesaredeveloped,reviewedandmodifiedbygroupsotherthantheFDA.GenitalHPVsareagroupofmorethan40relatedvirusesand,accordingtotheCentersforDiseaseControlandPrevention(CDC),arethemostcommonsexuallytransmittedinfections.Approximately14“high-risk”HPVtypesareassociatedwithcervicalcancer.Inmostcases,ahigh-riskHPVinfectiongoesawayonitsownanddoesnotcauseanyhealthproblems.However,about10percentofwomeninfectedwithhigh-riskHPVdevelopapersistentinfectionwhichmayputthematriskofcancer.VirtuallyallcervicalcancersarecausedbyHPVinfections,withjusttwotypes,HPV16andHPV18,responsibleforapproximately70percentofcervicalcancers.DatasupportingtheuseofthecobasHPVTestasaprimaryscreeningtestforcervicalcancerincludedastudyofmorethan40,000women25yearsandolderundergoingroutinecervicalexams.WomenwhohadapositivePaptestorwhosecervicalcellsscreenedpositiveforHPV,aswellasasubsetofwomenwhosePapandHPVtestswerebothnegative,underwentacolposcopyandcervicaltissuebiopsy.AllbiopsyresultswerecomparedtothePapandcobasHPVTestresults.Datafromthisstudy,whichincludedthreeyearsoffollow-uponwomenwhowenttocolposcopy,showedthatthecobasHPVTestissafeandeffectiveforthenewindicationforuse.ThecobasHPVTestismanufacturedbyRocheMolecularSystems,Incorporated,Pleasanton,Calif.Formoreinformation:March12,2014AdvisoryCommitteeMeeting(ACM)materialsFDA:MedicalDevicesFDA:OfficeofInVitroDiagnosticsandRadiologicalHealthCentersforDiseaseControlandPrevention--HumanPapillomavirusInformationNationalInstitutesofHealth:HPVandCancerTheFDA,anagencywithintheU.S.DepartmentofHealthandHumanServices,protectsthepublichealthbyassuringthesafety,effectiveness,andsecurityofhumanandveterinarydrugs,vaccinesandotherbiologicalproductsforhumanuse,andmedicaldevices.Theagencyalsoisresponsibleforthesafetyandsecurityofournation'sfoodsupply,cosmetics,dietarysupplements,productsthatgiveoffelectronicradiation,andforregulatingtobaccoproducts.