ISO TS 04425-2023.docx

TECHNICA1.SPECIFICATIONISO/TS4425editionFirst2O23-O4Genomicsinformatics-Datae1.ementsandtheirmetadatafordescribingthemicrosate1.1.iteinstabi1.ity(MSI)informationofc1.inica1.massivepara1.1.e1.DNAsequencingInfbrmatiquegnomique-6怙mentsdedonnesetIeursmtadonnespourdicrireIesinformationsre1.ativesinstabi1.itdesmicrosate1.1.ites(MSI)dus6quenagemassifpara1.1.i1.ed,ADN1.SOTSRj5c2oOT©ISO2023COPYRIGHTPROTECTEDDOCUMENT©ISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.orbmtndH0tf1.t×t'oni(nc4nmpe*Mqnrt<ifp5tcopyp>iat<)nmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountryoftherequester.f),WV>fifiHipB1.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForeword1234567.2.2Genera1.B7.32Genera1.'7.3.5Subjectofcare97.5Performing107.5.3InformationOn1.ega1.1.yconfirmed107.7 7.6.2statusresu1.tinformation117.8 Recommended11838.3.1infOnnat1.On.13iiiPageIntroductionviScope1Normativereferences1Termsanddefinitions1Abbreviatedterms5Microsate1.1.iteinstabi1.ity(MSI)5Compositionofe1.ementsfordescribingMSIstatusonc1.inica1.DNANGSreport661Gener3166.2Summarypart7Fie1.dsandtheirnomenc1.atureofrequireddata77.1Genera1.77.2C1.iniedISeqUenCingOrder87.2.1C1.inica1.sequencingordercode7.2.3Dateandtime87.3Infornistiononsubjectofc6.97.3.1Subjectofcareidentifier7<<kn0rCfrer!，。97.3.4Subjectofcarebirthdate97.3.67.3.7Referringdiagnosis,107.4Informationon1.ega1.1.yauthorizedpersonorderingc1.inica1.sequencing107.4.1 Genera1.1.aboratory7.4.2 Genera1.107.4.3 Basicinformationonperforming1.aboratory107.5.4 ofreportgeneratorpersononsequencingreport7.6Biospccimeninformation107.6.1 Genera1.10MSITypeofspecimen,7.1,7.2,8.1,8.2,8.377777Genera1.11MSIstatus11Genera1.treatmentModicstioii.11C1.inica1.tria1.information11Fie1.dsandtheirnomenc1.atureofoptiona1.data128.1 Gener2.一.128.2 Referencegenomeinformation12MSIGenera1.8.3.2 CriteriaofMS1.status138.3.3 GenomicpositionfordeterminingMSIstatus138.3.5G1.inuf1.iiaaSiimti<4fi1.smrhEaitCrna1.iVemCthOd.一.138.4Sequencinginformation13841CIIniCa1.sequencingdate13胱41.Jcingc(J¾RWetrics138.4.4 Sequencingp1.atforminformation148.4.5 Ana1.ysisp1.atforminormatn14AnnexA(informative)Examp1.estructureofMSIstatusreport16Bib1.iography19ForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsBuchugh(ISOtnrhniroibirH)tR¼,kWpaphngbody1.ntnoi6tat(bW(no!hntart>edmitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnongovernmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceareg殿F睽CiMteoSOIEC½teM槌必得杷油醐解蝴蟠($临酢%COrdanCe朗Fhtheeditoria1.ru1.esoftheSOIECDirectives,Part2(seewww.iso.org/directivcs).AnytradeusedinthisR曲拈OnHggd醐曲Bn捣媲蝴掘网群ns1.雅翩瞰R的阳赧府docf1.旅邮帖由银版subjectofanypatentrightsidentifiedduringthedeve1.oPmentCfxh。UXuJnMuUU4。beintheIntroductionand/orontheISO1.istofpatentdec1.arationsreceived(secwww.iso.org/patents).constitutenameendorsement,domentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand觊版U隅现dwn察脚阳6assE盛ftinwe憎s<曲船CnBar池恻Jdead唧乩e盘www.iso.org/iso/foreword.htm1.用i卜称锁/用用P沃edbyTechnica1.CommitteeISO/TC2151.Hea1.thinformatics,SubcommitteeAnyfeedbackorquestionsonthisdocumentshou1.dbedirectedtotheuser*snationa1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundIntroductionMassive1.ypara1.1.e1.sequencingisahigh-throughputana1.ytica1.approachtonuc1.eicacidsequencingthathU。VVbWhO1.eUSedgAnhn1.的JmCaAftDimUMKfcBiddiniCific口iagtod女a空tw8ppJiMhtahMid(p<H9a1.izedHiedicineandprecisionmedicine.1SOTS20428(ihasbeendeve1.opedforc1.inica1.usage.1.rafio1.anti-cancerche11i1.>ffiePaies.varicnisreS?entStrategiestheconf11)iperforme1.111.ferf1.yy1.te11ronthatmaintainstheactiontoextractcancerce1.1.s.Recentoutcomesofc1.inica1.tria1.sshowthatthisimmunetherapyisefficientforsomepatientswhohaveaspecificmo1.ecu1.archaracteroftheirtumor三ss.ua,sbWersC4sc1.1H即刑郃曲随她理腼公办“8松1<era1.M1.BI½ersreportedthatthestatusofMSI(microsate1.1.iteinstabi1.ity)isregardedasJrbiomarkerthatdrugsbasedonimmuno-therapyaremoreefficientforthepatientwithMS1.-H(high)3.Bb件的照)璘格皿ftMiWI11AHPH8HgyAU创dmgn啦蜃自JQW&隘。H蛇单曲雀海帆g(ctswereapprovedforcompaniondiagnostics.Amongtheseproducts,threeNGSsequencingprovideMS!statsandva1.ueonthei