Download myGenomics Hereditary Requisition

CancerTestRequisitionForm
CollectionDate(mm/dd/yyyy):____________________________
OfficeUseOnly:
DateReceived:____________________________________________________________
SpecimenType:!Buccal!Blood(2mLinlavendertoptube)
PATIENTINFORMATION
!Saliva!Other_________________________________
_________________________________________________________________________________________________________________________
FirstName
MiddleName
LastName
______________________________________________________________________________________________________________________________________________________________________________________
StreetAddress
______________________________________________________________________________________________________________________________________________________________________________________
City State
ZipCode
HomePhone:________________________________________________________
Gender: ☐Male☐FemaleDOB(mm/dd/yyyy):________________________________
Ancestry:☐AfricanAmerican☐Caucasian☐Hispanic☐European☐MiddleEastern☐Asian☐Ashkenazi-Jewish☐Central/SouthAmerican
☐Other_______________________________________________________
ORDERINGACCOUNTINFORMATION
_________________________________________________________________________________________________________________________
PracticeName
ProviderName
ProviderNPI#
______________________________________________________________________________________________________________________________________________________________________________________
StreetAddress
______________________________________________________________________________________________________________________________________________________________________________________
City
State
ZipCode
OfficePhone:__________________________________________OfficeFax:__________________________________________Email:_____________________________________________________________
AdditionalPhysicianorGeneticCounselortobecopied:Name:__________________________________________________________________Fax#:____________________________________
PHYSICIANAUTHORIZATION
Thistestismedicallynecessaryfortheriskassessment,diagnosisordetectionofadisease,illness,impairment,symptom,syndromeordisorder.Theresults
willdeterminemypatient’smedicalmanagementandtreatmentdecisions.Bymysignaturebelow,IindicatethatIamthereferringphysicianorauthorized
healthcareprovider.Ihaveexplainedthepurposeofthetest.Thepatienthasbeengiventheopportunitytoaskquestionsand/orseekgeneticcounseling.The
patienthasvoluntarilydecidedtohavethetestperformedbymyGenomics.
__________________________________________________________________________________________________________
MedicalProfessionalSignature(required)
Date(mm/dd/yyyy)
PATIENTAUTHORIZATION
Signhereorontheconsentdocument.
IhavereadtheInformedConsentdocumentandgivemypermissiontomyGenomicstoperformgenetictestingasdescribed.Ialsogivepermissionformy
specimenandclinicalinformationtobeusedinde-identifiedstudiesatmyGenomicstoimprovegenetictestingandforpublication,ifappropriate.Mynameor
otherpersonalidentifyinginformationwillnotbeusedinorlinkedtotheresultsofanystudiesandpublications.IalsogivemyGenomicspermissiontoinform
meinthefutureaboutresearchopportunities,includingtreatmentsfortheconditioninmyfamily.
! Checkthisboxifyouwanttooptoutofresearchstudies.!Checkthisboxifyoudonotwishtobecontacted.
! CheckthisboxifyouareaNYresidentandgivemyGenomicspermissiontoretainanyremainingsamplelongerthan60daysafterthecompletionoftesting.
________________________________________________________________________________________
Patient/GuardianSignature Date(mm/dd/yyyy)
BILLINGINFORMATION
BillingType: !CommercialInsurance !Medicare!Medicaid
Priorauthorization#:_______________________________________________________________________
Pleasecompletethefollowingandattachacopyofthefrontandbackofthepatient’sinsurancecard(includesecondarywhenapplicable).
_______________________________________________________________________________________________ /___________________________________________________________________________________________________________
PrimaryInsuranceCarrier
ID#
Group#
SecondaryInsuranceCarrier
ID#
Group
_______________________________________________________________________________________________/___________________________________________________________________________________________________________
NameofInsuredPerson
RelationshiptoPatientNameofInsuredPerson
RelationshiptoPatient
_______________________________________________________________________________________________ /___________________________________________________________________________________________________________
InsuredDateofBirth
Startdateofcoverage InsuredDateofBirth
Startdateofcoverage
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MGV101/REV 09-16
PatientName:____________________________________
DateofBirth:________________________
PERSONALHISTORYOFCANCER(S)ORTUMOR(S)
☐ BreastCancer
AgeofDiagnosis:______________
☐ NoPersonalHistoryofCancer/Tumor
☐ OvarianCancer
AgeofDiagnosis:__________________
☐ER☐PR☐HER2☐TripleNegative☐Bilateral
☐TwoPrimaries☐InvasiveDuctal☐InvasiveLobular
☐DCIS☐LCIS☐Other:____________________________________________
☐Serous☐Mucinous☐Endometrioid
☐ ClearCell ☐LMP/Borderline
☐Other:__________________________________________________________________
☐ EndometrialCancerAgeofDiagnosis:______________
☐ PancreaticCancerAgeofDiagnosis:_________________
☐ ColorectalCancerAgeofDiagnosis:______________
☐ Melanoma
☐Serous☐Mucinous☐Endometrioid☐ClearCell
☐Sarcoma
☐Other:____________________________________________________________
☐Adenocarcinoma☐IPMN
☐Neuroendocrine
☐Other:__________________________________________________________________
Location:☐Right☐Left☐Transverse☐Rectum
☐ ProstateCancer
AgeofDiagnosis:______________
☐Invasive☐In-Situ
☐ Polyp(s)
☐GleasonScore:__________________________________________________
☐Other:___________________________________________________________
☐ GastricCancer/TumorAgeofDiagnosis:______________
☐ BrainCancerAgeofDiagnosis:___________________
Pathology:_____________________________________________________________
☐ RenalCancer
☐ThyroidPathology/Diagnosis:______________________________
☐Pheochromocytoma(PCC)
☐Paraganglioma(PGL)Location:_______________________________
☐ HematologicDisease
AgeofFirstPolyp:_________________
☐Adenomatous–total#:______________________________________________
☐Other–Pathology:_______________________________Total#:__________
Pathology:________________________________________________________
☐ EndocrineCancer/DiseaseAgeofDiagnosis:______________
AgeofDiagnosis:__________________
AgeofDiagnosis:__________________
☐Bilateral☐ClearCell
☐PapillaryType(IorII):______________________________________________
☐TransitionalCell☐Other__________________________________________
AgeofDiagnosis:_______________
☐ OtherCancer/Tumor________________________________________
Diagnosis:______________________________________________________________
Status:☐Active/ResidualDisease☐Remission
AgeofDiagnosis:______________________________________________
FAMILYHISTORYOFCANCER(S)ORTUMOR(S)
☐ NoKnownFamilyHistoryofCancer(s)orTumor(s)☐PedigreeAttached☐Adopted
Pleaseincludeallclinicaldetails,suchasbilateral,pathology(includingtriplenegativebreastcancer),premenopausalbreastcancer,
andGleasonscoreforprostatecancer,ifavailable.
Relationship
Maternal Paternal
Cancer/TumorSite
AgeatDiagnosis
________________________________________
☐
☐
__________________________________________________________ ____________________
________________________________________
☐
☐
__________________________________________________________ ____________________
________________________________________
☐
☐
__________________________________________________________ ____________________
________________________________________
☐
☐
__________________________________________________________ ____________________
PERSONALGENETICTESTINGHISTORY(Pleaseincludeallcopiesoftestsandrelatedmedicalrecords.)
☐ NoPersonalHistoryofGeneticTesting
☐ Gene(s)Tested:_______________☐Positive☐Negative/_______________☐Positive☐Negative/_______________☐Positive☐Negative
_______________☐Positive☐Negative/_______________☐Positive☐Negative/_______________☐Positive☐Negative
PREVIOUSFAMILIALGENETICTESTING
☐ NoFamilyHistoryofGeneticTesting☐RelativeTested:______________________________Gene(s)Tested:________________________
☐Positive☐Negative☐VUS(VariationofUnknownSignificance)
CLIA#11D2084528
11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005
1-855-647-4363
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MGV101/REV 09-16
PatientName:____________________________________
DateofBirth:________________________
HC0001
AdenomatousPolyposisPanel
(2Genes)
APC,MUTYH
ApplicableICD-10codesmayinclude: D12.0 D12.1 D12.2 D12.3 D12.4 D12.5 D12.6
D12.7 D12.8 D37.4 D37.5 D48.1 D49.0 Z83.71 Z86.010 Z87.39
OtherICD-10codes:_____________________________________________________________________________________________
HC0002
BreastBasicCancerPanel
(2genes)
BRCA1,BRCA2
ApplicableICD-10codesmayinclude: C50.929 D05.00 D05.90 D07.30 Z15.01 Z15.02
Z80.3 Z80.41 Z80.42 Z84.81 Z85.3 Z85.43 OtherICD-10codes:__________________________
HC0003
BreastCancerHigh/ModRiskPanel
(8genes)
ATM,BRCA1,BRCA2,CDH1,CHEK2,PALB2,PTEN,TP53
ApplicableICD-10codesmayinclude: C50.929 D05.00 D05.90 D07.30 Z15.01 Z15.02
Z80.3 Z80.41 Z80.42 Z84.81 Z85.3 Z85.43 OtherICD-10codes:__________________________
HC0004
BreastCancerPanel
(44Genes)
ACVR1B,AKT1,ATM,BAP1,BRCA1,BRCA2,CBFB,CDH1,CDKN2A,EGFR,EP300,ERBB2,
ERBB3,ESR1,EXOC2,EXT2,FBXO32,FGFR1,FGFR2,GATA3,IRAK4,ITCH,KMT2C,
MAP2K4,MAP3K1,MDM2,MUC16,MYC,NCOR1,NEK2,PBRM1,PCGF2,PIK3CA,PIK3R1,
PPM1L,PTEN,PTGFR,RB1,RET,SEPT9,TP53,TRAF5,WEE1,ZBED4,
ApplicableICD-10codesmayinclude: C50.929 D05.00 D05.90 D07.30 Z15.01 Z15.02
Z80.3 Z80.41 Z80.42 Z84.81 Z85.3 Z85.43 OtherICD-10codes:__________________________
HC0005
Breast/OvarianCancerPanel
(21Genes)
ATM,BARD1,BRCA1,BRCA2,BRIP1,CDH1,CHEK2,EPCAM,FANCC,MLH1,MSH2,MSH6,
NBN,PALB2,PMS2,PTEN,RAD51C,RAD51D,STK11,XRCC2,TP53
ApplicableICD-10codesmayinclude: C50.929 D05.00 D05.90 D07.30 Z15.01 Z15.02
Z80.3 Z80.41 Z80.42 Z84.81 Z85.3 Z85.43 OtherICD-10codes:__________________________
HC0006
OvarianCancerPanel
(32Genes)
AKT1,ARID1A,BRAF,BRCA1,BRCA2,CBLC,CCNE1,CDK12,CDKN2A,CSMD3,CTNNB1,
CUBN,EGFR,ERBB2,FAT3,GABRA6,KIT,KRAS,KREMEN1,MAS1L,MLH1,MSH2,NF1,
NRAS,PDGFRA,PIK3CA,PIK3R1,PPP2R1A,PTEN,RB1,TP53,USP16
ApplicableICD-10codesmayinclude: C50.929 D05.00 D05.90 D07.30 Z15.01 Z15.02
Z80.3 Z80.41 Z80.42 Z84.81 Z85.3 Z85.43 OtherICD-10codes:__________________________
HC0007
ColorectalCancerPanel
(38Genes)
ACVR1B,AKT1,APC,ATM,ATP6VOD2,BAX,BRAF,CASP8,CDC27,CTNNB1,DCC,DMD,
EP300,ERBB2,FBXW7,FZD3,GPC6,KRAS,MAP2K4,MAP7,MIER3,MLH1,MSH2,MSH3,
MSH6,MYO1B,NRAS,PIK3CA,PIK3R1,PTPN12,SLC9A9,SMAD2,SMAD4,TCERG1,
TCF7L2,TGFBR2,TP53,WBSCR17
ApplicableICD-10codesmayinclude: C18.9 C19 C20 C21.0 D01.0 D01.1 D01.2
D01.3 D01.40 D01.7 D01.9 K63.5 Z80.0 Z83.71 Z83.79 Z84.81 Z85.00
Z86.010OtherICD-10codes:________________________________________________________________________________
HC0008
EndocrineNeoplasiaPanel
(7Genes)
CDC73,HRAS,MEN1,PRKAR1A,PTEN,RET,VHL
ApplicableICD-10codesmayinclude: C70.0 C70.1 C70.9 C75.0 C75.1 D09.3 D17.9
D42.9 E21.5 E23.7 Z15.81 Z83.41 Z83.49 Z84.81 Z85.850 Z85.858
OtherICD-10Codes:__________________________________________________________________________________________
HC0009
EndometrialCancerPanel
(12Genes)
BRCA1,BRCA2,CHEK2,EPCAM,MLH1,MSH2, MSH6,MUTYH,PMS2,POLD1,PTEN,TP53
ApplicableICD-10codesmayinclude: N85.0 N85.00 C54.1 C54.2 Z15.04
OtherICD-10codes:__________________________________________________________________________________________
HC0010
GastricCancerPanel
(29Genes)
APC,ATP4A,BAI3,BRCA2,CCNE1,CDH1,CTNNB1,DCC,ERBB2,FBXW7,FGFR2,GPR78,
LPAR2,PRP1B,LRRK2,MET,MYC,NOTCH1,PIK3CA,PRKDC,RET,S1PR2,SPEG,SSTR1,
STK11,TP53,TRIO,TRRAP,WNK2
ApplicableICD-10codesmayinclude: C15.9 C16.9 C17.9 D00.1 D00.2 D05.90 Z80.0
Z84.81 Z85.00 OtherICD-10codes:____________________________________________________________________
HC0011
Li-FraumeniSyndromeCancerPanel
(2Genes)
CHEK2,TP53
ApplicableICD-10codesmayinclude: C41.9 C49.9 C50.919 C50.929 C71.9 C74.90
D05.00 D05.10 D05.90 D09.8 D43.2 D43.4 Z85.830
OtherICD-10codes:__________________________________________________________________________________________
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MGV101/REV 09-16
HC0012
LiverCancerPanel
(33Genes)
ALB, AMPH, APC, ARID1A, ARID2, ATM, AXIN1, BAZ2B, BRAF, CCDC178, CDKN2A, CSMD3, CTNNB1,
DSE, ELMO1, ERBB2, ERRFI1, GXYLT1, IGF2R, IGSF10, KEAP1, KRAS, MET, NHF1A, OTOP1, PIK3CA,
SAMD9L, TP53, UBR3, USP25, WWP1, ZIC3, ZNF226
ApplicableICD-10Codesmayinclude: C22.8 E83.11 OtherICD-10codes:_________________________
HC0013
LungCancerPanel
(45Genes)
AKT1,ALK,APC,ATM,BAI3,BAP1,BRAF,CDKN2A,EGFR,EPHA5,ERBB2,ERBB4,FBXW7,FGFR1,
FGFR2,GRM8,KDR,KEAP1,KIT,KMT2D,KRAS,LRP1B,MDM2,MET,MLH1,MUC16,MYC,NF1,
NFE2L2,NOTCH1,PDGFRA,PIK3CA,PIK3CG,PKHD1,PTEN,RARB,RB1,RET,ROS1,RUNX1T1,
SMAD4,SMARCA4,SOX2,STK11,TP53+in/del
ApplicableICD-10codesmayinclude: D38.1 C34.80 C34.90 C34.12 C34.81 C34.82
Z85.118 Z80.1 OtherICD-10codes:___________________________________________________________________
HC0014
Lynch/ColorectalCancerPanel
(8Genes)
APC, EPCAM, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN
ApplicableICD-10codesmayinclude: C18.9 C19 C20 C21.0 D01.0 D01.1 D01.2
D01.3 D01.40 D01.7 D01.9 K63.5 Z80.0 Z83.71 Z83.79 Z84.81 Z85.00
Z86.010OtherICD-10codes:________________________________________________________________________________
HC0015
MelanomaCancer
Panel(13Genes)
BAP1, BRCA2, CDK4, CDKN2A, MC1R, MITF, NF1, PTEN, RB1, TP53, VH1, XPA, XPC
ApplicableICD-10codesmayinclude: C25.9 C43.9 D01.7 D01.9 D03.9 D04.9 Z80.0
Z80.8 Z84.81 Z85.820 OtherICD-10codes:________________________________________________________
HC0016
PachyonychiaCogenita
Panel(9Genes)
AAGAB, DSG1, GJB6, KRT6A, KRT6B, KRT6C, KRT16, KRT17, TRPV3
ApplicableICD-10codesmayinclude: Q84.3 Q84.4 Q84.5 Q84.6
OtherICD-10codes:_________________________________________________________________________________________
HC0017
PancreaticCancerPanel
(16Genes)
APC,ATM,BRCA1,BRCA2,CDK4,CDKN2A,EPCAM,MLH1,MSH2,MSH6,PALB2,PMS2,STK11,
TP53,VHL,XRCC2
ApplicableICD-10codesmayinclude: C25.9 C80.1 D01.7 D01.9 Z80.0 Z84.81 Z85.07
OtherICD-10codes:_________________________________________________________________________________________
HC0018
ProstateCancerPanel
(32Genes)
AKAP9,APC,AR,CDK12,CDKN1B,CDKN2A,GLI1,IKZF4,KDM4B,KLF6,KMT2D,MED12,MYC,
NCOA2,NIPA2,NKX3-1,NRCAM,OR5L1,PDZRN3,PIK3CA,PTEN,RB1,SCN11A,SPOP,SYNE3,
TBX20,TFG,THSD7B,TP53,ZFHX3,ZNF473,ZNF595
ApplicableICD-10codesmayinclude: D07.5 R97.2 Z15.03 Z80.41 Z80.42 Z84.81
Z85.46
OtherICD-10codes:_________________________________________________________________________________________
HC0019
RenalCancer
Panel(19genes)
BAP1,EPCAM,FH,FLCN,MET,MITF,MLH1,MSH2,MSH6,PMS2,PTEN,SDHA, SDHB,SDHC,SDHD,
TP53,TSC1,TSC2,VHL
ApplicableICD-10codesmayinclude: C64.9 C65.1 C65.2 C65.9 V16.51
OtherICD-10codes:________________________________________________________________________________________
HC0020
TruSight Cancer Predisposition panel
(94 Genes+284SNPs)
AIP,ALK,APC,ATM,BAP1,BLM,BMPR1A,BRCA1,BRCA2,BRIP1,BUB1B,CDC73,CDH1,CDK4,
CDKN1C,CDKN2A,CEBPA,CEP57,CHEK2,CYLD,DDB2,DICER1,DIS3L2,EGFR,EPCAM,ERCC2,
ERCC3,ERCC4,ERCC5,EXT1,EXT2,EZH2,FANCA,FANCB,FANCC,FANCD2,FANCE,FANCF,FANCG,
FANCI,FANCL,FANCM,FH,FLCN,GATA2,GPC3,HNF1A,HRAS,KIT,MAX,MEN1,MET,MLH1,MSH2,
MSH6,MUTYH,NBN,NF1,NF2,NSD1,PALB2,PHOX2B,PMS1,PMS2,PRF1,PRKAR1A,PTCH1,PTEN,
RAD51C,RAD51D,RB1,RECQL4,RET,RHBDF2,RUNX1,SBDS,SDHAF2,SDHB,SDHC,SDHD,SLX4,
SMAD4,SMARCB1,STK11,SUFU,TMEM127,TP53,TSC1,TSC2,VHL,WRN,WT1,XPA&XPC
ICD-10codes:________________________________________________________________________________________________
HC0021
HereditarySingleGeneorGeneSet
RequestedGene(s):____________________________________________________________________________________________
ICD-10codes:________________________________________________________________________________________________
Requested Gene(s): ____________________________________________________________________________________________
HC0022
VariantTesting(previously
identifiedfamilialmutation)
ICD-10codes: ________________________________________________________________________________________________
RequestedGene(s):____________________________________________________________________________________________
ICD-10codes:________________________________________________________________________________________________
HC0023
FocusedExomeTesting
(5,500genes)
ICD-10codes:________________________________________________________________________________________________
HC0024
WholeExomeSequencingTRIO
(22,000genes)
ICD-10codes:________________________________________________________________________________________________
HC0025
WholeExomeSequencingPROBAND
ICD-10codes:________________________________________________________________________________________________
HC0026
WholeExomeSequencingAdditional
FamilyMember
ICD-10codes:________________________________________________________________________________________________
HC0027
WholeGenome
ICD-10codes:________________________________________________________________________________________________
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MGV101/REV 09-16
InformedConsentandAuthorizationForm
Iunderstandthatmyhealthcareproviderhasorderedthefollowinggenetictestingfor:☐Me☐MyChild
Signature:__________________________________________________________
Whatisgenetictesting?
Genetictestingisananalysisofaperson’sgeneticmakeup.Everyoneisbornwithadistinctsetofgenesthatisuniqueto
them. These genes provide instructions for the body to grow and develop. Sometimes a person’s genes may be altered
during formation and could lead to a specific syndrome, disease or birth defect. Depending on the type of genetic test
ordered,ageneticconditionorseveralconditionscouldbedetectedthatincreaseyourriskofasyndrome,diseaseand/or
defect. Your provider or a genetic counselor should inform you about these conditions for which you are being offered
testing.Youmayalsoneedtofollowupwithageneticcounselororyourprovidertodiscusstheresultsafterthetesting.
Whatisthepurposeofgenetictesting?
Thegenetictestisconsideredapredictivetestifitisperformedtoidentifywhetherapatientisatanincreasedriskof
developingahereditarydefectordiseasebutdoesnotdetermineforcertainthatadefectordiseasewilloccur.Ifagenetic
testisbeingperformedafteradefectordiseasehasbeendiagnosedandthetestconfirmsthecausetobeinrelationtothe
gene(s),itisconsideredadiagnosticorconfirmatorytest.
Howisagenetictestperformed?
Genetictestsareusuallyperformedbyeitherbloodtestingorobtainingtissueorcheekcellsamples.Thesesamples
containwhitebloodcellsthatcontainyourDNA,RNAandimportantproteins.Whentestingduringpregnancy,chorionic
villus,amnioticfluidorasampleofthemother’sbloodcanbeused.
Whatarethelimitationsofgenetictesting?
Agenetictestmayprovideveryimportantinformationaboutyourhealthbuttherearelimitations:
• Performingthecorrecttest:Iftheproviderdoesnothaveanaccuratepersonalorfamilyhistorytodetermine
whichgenetictest(s)areimplicated,theincorrectorincompletetest(s)maybeordered.
• LaboratoryProcessing:Alllaboratoriesmustmeettheproperrequirementstoprocessyoursampleandstrict
guidelinesmaybeinplacetoensuretheserequirements;however,inrarecases,problemsmayoccurinhandling
thesample,whichmightleadtoincorrectresults.
• ImplicationsofResults:Thegenetictestmayrevealanalterationinageneorseveralgenesbuttheremaybelimits
towhatisknownabouteachgeneandthesignificanceoftheresultmaybeuncertain.Ageneticalterationor
variationcannotdeterminewhetheryouwillactuallydevelopasuspectedcondition,thetimingofitsdevelopment
ortheseverityofthecondition.
Itisimportantthatyoudiscussyourgenetictestresultwithyourprovidersothatyoucanmakeaninformeddecision
aboutyournextsteps.
Whatarethebenefitsofgenetictesting?
Thereareseveralbenefitstoperforminggenetictesting.Ifageneticvariationisdetermined,
• Theremaybepreventivemeasuresoridentifiedmedicaltreatmentsthatdecreaseyourchancesofdevelopinga
relatedgeneticsyndrome,diseaseordefect.
• Theknowledgecanempowerapersontomakeimportantchoicesaboutlifeplanning,evenifacureisnotavailable
atthetimeoftesting.
• Apersonmayqualifytoenrollinarelatedresearchstudy,whichmayleadtonewtreatments.
• Itmayprovideimportanthealthinformationforaperson’sfamily.
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Whataretherisksofgenetictesting?
Therearepossiblerisksofgenetictesting:
• Althoughlowrisk,theremaybeaphysicalriskinvolvedinobtainingthesamplefortesting.
• Therearepotentialpsychologicalandsocialrisksoftestingbecausetheycanchangeaperson’slifeperspective.It
maybestressfulandtheremaybeanemotionalreactiontolearningaboutrisksforyourselforyourfamily.Thisis
whyitisimportanttodiscussthetestingwithyourprovideroraGeneticCounselorbeforetesting.
• Therearepossibleeconomicrisksofgenetictestingthatmayinterferewithapatient’sabilitytoobtainhealth,life,
disabilityorlong-termcareinsurance.
• Thegenetictestresultswillbecomeapartofyourmedicalrecord.Ifagenetictestisperformed,yourinsurance
companymayhaveaccesstotheresult.
• Therearebothstateandfederallawsthatweredevelopedtohelpprotectapersonfromgeneticdiscrimination,
whichisthemisuseofgeneticinformation.GINAistheGeneticInformationNondiscriminationActof2008andisa
federallawthatprotectsindividualsfromgeneticdiscriminationinhealthinsuranceandemployment.
WhatcanIlearnfrommygenetictestresult?
Resultscanbeclassifiedasnegativeorpositive.
• Anegativeor“normal”resultmeansthetestdidnotdetectavariationorchangeinthegene(s)tested.Thismayhave
limitationsinthatallgenesrelatedtoaparticularconditionmaynothavebeentested.Therefore,anegativetest
doesnotalwaysruleoutthedevelopmentofaproblematicgeneticcondition.Also,technologyimproveseveryyear
andtheremaybenewdiscoveriesthatareassociatedwithaparticulargeneticconditionthatwasunknownatthe
timeoftesting.
• Apositiveor“abnormal”resultmeansthatyouhaveageneticchangeorvariationthatisrelatedtothedevelopment
ofaspecificgeneticconditionthatmayputyouatanincreasedrisk.However,notallgenevariationsleadto
symptomsorthedevelopmentofthegeneticcondition.
• Aninconclusiveresultmeansthatitmayfallbetweena“normal”or“abnormal”rangeorbe“indeterminate.”Insuch
cases,thismaybelabeledasaVUSorvariantofunknownsignificance.Eventhoughachangeinthegenemaybe
detected,thelaboratorymaynothaveenoughinformationtodetermineifthegeneplacesapersonatanincreased
risk.Laboratoriesmaylearnmoreaboutthatvariantinthefutureandbeabletomakeamoredefinitivedecision
aboutthesignificanceofthegenevariation.
• Inrarecases,agenetictestmayrevealanimportantgeneticvariationthatisnotdirectlyrelatedtothereasona
providerorderedthetest.Theseresultsarecalledsecondaryorincidentalfindings.Examplesmayinclude:
- Non-paternity:Thepersondesignatedasthefatherisnotthebiologicalfatherofthepersonhavingtesting.
- Consanguinity:Thebiologicalparentsarecloselyrelatedbyblood.
- Identificationofaconditionunrelatedtothereasonfortesting
Resultinterpretationisbasedoncurrentandavailableinformationpresentinmedicalliterature,researchandscientific
databases.Becausetheseresourcesareconstantlychanging,newinformationthatbecomesavailableinthefuturemayreplace
oraddtotheinformationmyGenomicsusedtointerpretaperson’stestresults.myGenomicsdoesnotroutinelyre-analyze
testresultsthathavealreadybeenissuedandhasnoobligationtodoso.Apersonmaymonitorpubliclyavailableresources
suchasClinVar(www.clinvar.com)tolearnaboutcurrentinformationabouttheclinicalinterpretationofagenetictest.
Whathappenstomysampleaftertesting?
DNAsamplesarenotreturnedtoapersonafterthetesthasresulted.De-identifiedsamplesandde-identifiedtestresults
maybestoredinarepositoryandusedforinternalvalidation,educational,researchpurposesincludingHIPAA-compliant
databasesorpresentedinscientificpresentationsorpapers.
Researchwithde-identifiedsamplesandtestdatathatresultsinmedicaladvancesmayhavepotentialcommercialvalueand
maybedevelopedandownedbymyGenomicsortheresearcherswhoanalyzethedata.Ifanyindividualorcorporation
benefitsfinanciallyfromstudyingaperson’sde-identifiedgeneticmaterial,nocompensationwillbeprovidedtotheperson
orperson’sheirs.
myGenomicshasnoobligationtoretainaperson’ssampleindefinitelyandmaydestroyitonceitnolongerhasalegalduty
toretainit.Byconsentingtothisagreement,IprovideauthorizationformyGenomicsanditspartnerstousemyormychild’s
de-identifiedsampleandtestresultsforsuchpurposesasmentionedabove.
Unlessoptedoutonthefirstpageoftherequisition,myGenomicsmaycontactmeinthefutureregardingtheopportunityto
participateinresearchopportunities,includinganyavailabletreatmentformyselfand/ormyfamily.
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11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005
1-855-647-4363
www.mygenomics.com
MGV101/REV 09-16
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IunderstandthatImaycontactmyGenomicsviaemailatinfo@mygenomics.comorbyphoneat1-855-647-4363ifIwish
tooptoutoffuturecontactorhaveanyquestionsrelatedtomytestresults.
☐ IunderstandthatsamplesfromresidentsofNewYorkStatewillnotbeincludedinthede-identifiedresearchstudiesdescribedinthis
authorizationandwillnotberetainedformorethan60daysaftertestcompletion,unlessspecificallyauthorizedbymyselectionbelow.
TheauthorizationisoptionalandtestingwillnotbeaffectedifIdonotchecktheboxfortheNewYorkauthorizationlanguage.
☐ InternationalSpecimens:IfmychildorIresideoutsideoftheUnitedStates,Iattestthatbyprovidingasamplefortesting,
Iamnotknowinglyviolatinganyexportbanorotherlegalrestrictioninthecountryofmyormychild’sresidence.
☐ PatientConfidentialityandGeneticCounseling:ItisrecommendedthatmychildorIreceivegeneticcounselingbeforeandafterthe
genetictest.Furthertestingorconsultationswithahealthcareprovidermaystillbenecessary.Tomaintainconfidentiality,thetestresults
willonlybereleasedtothereferringhealthcareprovider,totheorderinglaboratory,tomeorotherhealthcareprovidersinvolvedinmy
ormychild’sdiagnosisandtreatment,ortoothersasentitledbylaw.TheUnitedStatesFederalGovernmenthasenactedseverallawsthat
prohibitdiscriminationbasedongenetictestresultsbyhealthinsurancecompaniesandemployers.Inaddition,theselawsprohibit
unauthorizeddisclosureofthisinformation.Formoreinformation,IunderstandthatIcanvisitwww.genome.gov/10002077.
PatientAcknowledgement:Byagreeingtothisauthorization,Iacknowledgethefollowing:
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Iameither(1)thepatientprovidingthesampleandamatleast18yearsofageor(2)Ihavelegalauthorizationtoprovidethisinformed
consentonbehalfofanotherperson.
Ihavereadandagreetothecontentsofthisform.
Iunderstandthebenefits,risksandlimitationsofgenetictesting.
Irecognizetheseriousnessofconditionsforwhichtestingisbeingordered,andthatdiseasedescriptions,prognoses,andtreatment
optionshavebeenmadeavailabletomebymyormychild’shealthcareprovider.
Ihavebeeninformedoftheavailabilityofgeneticcounselingservices.Icanfindageneticcounselorinmyareaat:www.nsgc.org.
Iwillbegiventheopportunitytodiscusstheresultsofthetestwithmyhealthcareprovider,onceIreceivethem.
Iamresponsibleforinformingmyorderinghealthcareproviderofchangesinmyormychild’sfamilyhistory.
IunderstandthatmyGenomicsmaycontactmeinthefutureforresearchopportunities,includingtreatmentsfortheconditioninwhich
myormychild’sfamily.(PleasechecktheboxattheendofthisAuthorizationifyouwishtooptoutoffutureresearchopportunities.)
IunderstandthatmyGenomicsmayusemyormychild’sde-identifiedinformationandtestresultsforvalidation,educationaland/or
researchpurposes,andthisde-identifieddatamaybesubmittedinaHIPAA-compliantmannertoresearchdatabases.
Fortestsorstudiesthatgeneratedatafrommultiplefamilymembersormyspouseorpartner,Iconsenttoallofthedatabeingincluded
inasinglecomprehensivereportthatwillbesharedwithparticipatingfamilymembers,myspouseorpartner.
IfmyGenomicsoracontractedpartnerofmyGenomics(collectively,“myGenomicsPartners”)isbillingmymedicalinsurancecarrier
directly,IrepresentthatIamcoveredbyinsuranceandauthorizemyGenomicsPartnerstogivemydesignatedinsurancecarrier,health
plan,orthirdpartyadministrator(collectively,“Plan”)theinformationonthisformandotherinformationprovidedbymyhealthcare
providernecessaryforreimbursement,andIauthorizePlanbenefitstobepayabledirectlytomyGenomicsPartners.
IauthorizemyGenomicsPartnerstoinformmyPlanofmytestresult(s)onlyifthetestresult(s)arerequiredforpreauthorizationof,or
paymentfor,additionaltesting.
IwillcooperatefullywithmyGenomicsPartnersbyprovidingallnecessarydocumentsneededforinsurancebillingandappeals;and
understandthatIamresponsibleforsendingmyGenomicsPartnersany,andall,ofthemoneythatIreceivedirectlyfrommyinsurance
companyinpaymentforthethistest.Reasonablecollectionand/orattorney’sfees,includingfilingandservicefees,shallbeassessedif
theaccountissenttocollection,aspermittedbystatelaw.Ipermitacopyofthisauthorizationtobeusedinplaceoftheoriginal.
Finally,ifIhavethelegalauthorizationtoprovidethisinformedconsentonbehalfofanotherperson,Iamattestingthatthesample
providedbelongstothatperson.
Patient/GuardianAuthorization
Bymysignaturebelow,Iattestthefollowing:
IhavereadandIunderstandtheinformationprovidedonthisform.
OptOutforResearchandContact
☐ Idonotwishtoparticipateinanyresearchstudies.
☐ IdonotwishtobecontractedbymyGenomicsforfutureresearchopportunities.Iunderstandthatmyelectiontooptoutofsuchfollow
upcontactswillnotaffectmyabilitytoobtaintesting.
AuthorizationofNewYorkResidents
☐
IamaNewYorkstateresidentandIgivepermissionformyGenomicstoretainanyremainingsamplelongerthan60daysafter
completionoftestingandusemyde-identifieddataforscientificandmedicalresearchpurposes.Suchauthorizationisoptionalandisnot
requiredfortesting.
Patient/GuardianName:__________________________________________________________________________________________________________________________
FirstName
MiddleName
LastName
DateofBirth:mm/dd/yyyy
Patient/GuardianSignature:__________________________________________________________________________________ Date:______________________________
mm/dd/yyyy
HealthCareProvider’sStatement
Thistestismedicallynecessaryfortheriskassessment,diagnosisordetectionofadisease,illness,impairment,symptom,syndromeordisorder.
Theresultswilldeterminemypatient’smedicalmanagementandtreatmentdecisions.Bymysignaturebelow,IindicatethatIamthereferring
physicianorauthorizedhealthcareprovider.Ihaveexplainedthepurposeofthetestdescribedabove.Thepatienthasbeengiventheopportunity
toaskquestionsand/orseekgeneticcounseling.ThepatienthasvoluntarilydecidedtohavethetestperformedbymyGenomics.
HealthCareProvider’sSignature_____________________________________________________________________________ Date:______________________________
mm/dd/yyyy
CLIA#11D2084528
11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005
1-855-647-4363
www.mygenomics.com
MGV101/REV 09-16