Transcript

_________________________________________________________________________________________________________________________

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_______________________________________________________

Thistestismedicallynecessaryfortheriskassessment,diagnosisordetectionofadisease,illness, impairment,symptom,syndromeordisorder.Theresults

willdeterminemypatient’smedicalmanagementandtreatmentdecisions.Bymysignaturebelow,I indicatethatIamthereferringphysicianorauthorized

healthcareprovider.Ihaveexplainedthepurposeofthetest.Thepatienthasbeengiventheopportunitytoaskquestionsand/orseekgeneticcounseling.The

patienthasvoluntarilydecidedtohavethetestperformedbymyGenomics.

__________________________________________________________________________________________________________

MedicalProfessionalSignature(required) Date(mm/dd/yyyy)

Signhereorontheconsentdocument.

IhavereadtheInformedConsentdocumentandgivemypermissiontomyGenomicstoperformgenetictestingasdescribed.Ialsogivepermissionformy

specimenandclinicalinformationtobeusedinde-identifiedstudiesatmyGenomicstoimprovegenetictestingandforpublication,ifappropriate.Mynameor

otherpersonalidentifyinginformationwillnotbeusedinorlinkedtotheresultsofanystudiesandpublications.IalsogivemyGenomicspermissiontoinform

meinthefutureaboutresearchopportunities,includingtreatmentsfortheconditioninmyfamily.

! Checkthisboxifyouwanttooptoutofresearchstudies.!Checkthisboxifyoudonotwishtobecontacted.

! CheckthisboxifyouareaNYresidentandgivemyGenomicspermissiontoretainanyremainingsamplelongerthan60daysafterthecompletionoftesting.

________________________________________________________________________________________

Patient/GuardianSignature Date(mm/dd/yyyy)

BillingType: !CommercialInsurance !Medicare!Medicaid Priorauthorization#:_______________________________________________________________________

Pleasecompletethefollowingandattachacopyofthefrontandbackofthepatient’sinsurancecard(includesecondarywhenapplicable).

_______________________________________________________________________________________________ /___________________________________________________________________________________________________________

PrimaryInsuranceCarrier ID# Group# SecondaryInsuranceCarrier ID# Group

_______________________________________________________________________________________________/___________________________________________________________________________________________________________

NameofInsuredPerson RelationshiptoPatient NameofInsuredPerson RelationshiptoPatient

_______________________________________________________________________________________________ /___________________________________________________________________________________________________________

InsuredDateofBirth Startdateofcoverage InsuredDateofBirth Startdateofcoverage

_________________________________________________________________________________________________________________________

PracticeName ProviderName ProviderNPI#

______________________________________________________________________________________________________________________________________________________________________________________

StreetAddress

______________________________________________________________________________________________________________________________________________________________________________________

City State ZipCode

OfficePhone:__________________________________________OfficeFax:__________________________________________Email:_____________________________________________________________

AdditionalPhysicianorGeneticCounselortobecopied:Name:__________________________________________________________________Fax#:____________________________________

PATIENTINFORMATION

ORDERINGACCOUNTINFORMATION

PHYSICIANAUTHORIZATION

PATIENTAUTHORIZATION

BILLINGINFORMATION

CLIA#11D2084528 11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005 1-855-647-4363 www.mygenomics.com

CancerTestRequisitionFormCollectionDate(mm/dd/yyyy):____________________________

OfficeUseOnly:DateReceived:____________________________________________________________

SpecimenType:!Buccal!Blood(2mLinlavendertoptube)

!Saliva!Other_________________________________

MGV101/REV 09-16

PERSONALHISTORYOFCANCER(S)ORTUMOR(S) ☐ NoPersonalHistoryofCancer/Tumor

☐ BreastCancer AgeofDiagnosis:______________

☐ER☐PR☐HER2☐TripleNegative☐Bilateral☐TwoPrimaries☐InvasiveDuctal☐InvasiveLobular☐DCIS☐LCIS☐Other:____________________________________________

☐ OvarianCancer AgeofDiagnosis:__________________

☐Serous☐Mucinous☐Endometrioid☐ ClearCell ☐LMP/Borderline☐Other:__________________________________________________________________

☐ EndometrialCancerAgeofDiagnosis:______________☐Serous☐Mucinous☐Endometrioid☐ClearCell☐Sarcoma☐Other:____________________________________________________________

☐ PancreaticCancerAgeofDiagnosis:_________________☐Adenocarcinoma☐IPMN☐Neuroendocrine☐Other:__________________________________________________________________

☐ ColorectalCancerAgeofDiagnosis:______________Location:☐Right☐Left☐Transverse☐Rectum

☐Melanoma AgeofDiagnosis:__________________

☐Invasive☐In-Situ☐ ProstateCancer AgeofDiagnosis:______________☐GleasonScore:__________________________________________________☐Other:___________________________________________________________

☐ Polyp(s) AgeofFirstPolyp:_________________

☐Adenomatous–total#:______________________________________________☐Other–Pathology:_______________________________Total#:__________

☐ GastricCancer/TumorAgeofDiagnosis:______________Pathology:________________________________________________________

☐ BrainCancerAgeofDiagnosis:___________________Pathology:_____________________________________________________________

☐ EndocrineCancer/DiseaseAgeofDiagnosis:______________☐ThyroidPathology/Diagnosis:______________________________☐Pheochromocytoma(PCC)☐Paraganglioma(PGL)Location:_______________________________

☐ RenalCancer AgeofDiagnosis:__________________

☐Bilateral☐ClearCell☐PapillaryType(IorII):______________________________________________☐TransitionalCell☐Other__________________________________________

☐ HematologicDisease AgeofDiagnosis:_______________

Diagnosis:______________________________________________________________

Status:☐Active/ResidualDisease☐Remission

☐ OtherCancer/Tumor________________________________________

AgeofDiagnosis:______________________________________________

FAMILYHISTORYOFCANCER(S)ORTUMOR(S)

☐ NoKnownFamilyHistoryofCancer(s)orTumor(s)☐PedigreeAttached☐AdoptedPleaseincludeallclinicaldetails,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)

PatientName:____________________________________

DateofBirth:________________________

CLIA#11D2084528 11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005 1-855-647-4363 www.mygenomics.com MGV101/REV 09-16

�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:_____________________________________________________________________________________________

�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,USP16ApplicableICD-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,TP53ApplicableICD-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:__________________________________________________________________________________________

PatientName:____________________________________

DateofBirth:________________________

�HC0002 BreastBasicCancerPanel(2genes)

BRCA1,BRCA2ApplicableICD-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:__________________________

CLIA#11D2084528 11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005 1-855-647-4363 www.mygenomics.com MGV101/REV 09-16

�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, PTENApplicableICD-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 MelanomaCancerPanel(13Genes)

BAP1, BRCA2, CDK4, CDKN2A, MC1R, MITF, NF1, PTEN, RB1, TP53, VH1, XPA, XPCApplicableICD-10codesmayinclude:�C25.9�C43.9�D01.7�D01.9�D03.9�D04.9�Z80.0

�Z80.8�Z84.81�Z85.820�OtherICD-10codes:________________________________________________________

�HC0016 PachyonychiaCogenitaPanel(9Genes)

AAGAB, DSG1, GJB6, KRT6A, KRT6B, KRT6C, KRT16, KRT17, TRPV3ApplicableICD-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 RenalCancerPanel(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:________________________________________________________________________________________________

�HC0022 VariantTesting(previouslyidentifiedfamilialmutation)

Requested Gene(s): ____________________________________________________________________________________________�

�ICD-10codes: ________________________________________________________________________________________________

�HC0023 FocusedExomeTesting(5,500genes)

�ICD-10codes:________________________________________________________________________________________________

�HC0024 WholeExomeSequencingTRIO(22,000genes)

�ICD-10codes:________________________________________________________________________________________________

�HC0025 WholeExomeSequencingPROBAND �ICD-10codes:________________________________________________________________________________________________

�HC0026 WholeExomeSequencingAdditionalFamilyMember

�ICD-10codes:________________________________________________________________________________________________

�HC0027 WholeGenome �ICD-10codes:________________________________________________________________________________________________

�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, ZNF226ApplicableICD-10Codesmayinclude:�C22.8�E83.11�OtherICD-10codes:_________________________

RequestedGene(s):____________________________________________________________________________________________�

�ICD-10codes:________________________________________________________________________________________________

CLIA#11D2084528 11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005 1-855-647-4363 www.mygenomics.com MGV101/REV 09-16

InformedConsentandAuthorizationForm

Iunderstandthatmyhealthcareproviderhasorderedthefollowinggenetictestingfor:☐Me☐MyChildSignature:__________________________________________________________

Whatisgenetictesting?Genetictestingisananalysisofaperson’sgeneticmakeup.Everyoneisbornwithadistinctsetofgenesthatisuniqueto

them. These genes provide instructions for the body to grow and develop. Sometimes a person’s genesmay 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 informyou about these conditions forwhichyou 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.

CLIA#11D2084528 11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005 1-855-647-4363 www.mygenomics.com MGV101/REV 09-16

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.Eventhoughachangeinthegenemaybedetected,thelaboratorymaynothaveenoughinformationtodetermineifthegeneplacesapersonatanincreased

risk.Laboratoriesmaylearnmoreaboutthatvariantinthefutureandbeabletomakeamoredefinitivedecision

aboutthesignificanceofthegenevariation.

• Inrarecases,agenetictestmayrevealanimportantgeneticvariationthatisnotdirectlyrelatedtothereasona

providerorderedthetest.Theseresultsarecalledsecondaryorincidentalfindings.Examplesmayinclude:

- Non-paternity:Thepersondesignatedasthefatherisnotthebiologicalfatherofthepersonhavingtesting.

- Consanguinity:Thebiologicalparentsarecloselyrelatedbyblood.

- Identificationofaconditionunrelatedtothereasonfortesting

Resultinterpretationisbasedoncurrentandavailableinformationpresentinmedicalliterature,researchandscientific

databases.Becausetheseresourcesareconstantlychanging,newinformationthatbecomesavailableinthefuturemayreplace

oraddtotheinformationmyGenomicsusedtointerpretaperson’stestresults.myGenomicsdoesnotroutinelyre-analyzetestresultsthathavealreadybeenissuedandhasnoobligationtodoso.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’ssampleindefinitelyandmaydestroyitonceitnolongerhasalegaldutytoretainit.Byconsentingtothisagreement,IprovideauthorizationformyGenomicsanditspartnerstousemyormychild’s

de-identifiedsampleandtestresultsforsuchpurposesasmentionedabove.

Unlessoptedoutonthefirstpageoftherequisition,myGenomicsmaycontactmeinthefutureregardingtheopportunityto

participateinresearchopportunities,includinganyavailabletreatmentformyselfand/ormyfamily.

CLIA#11D2084528 11535ParkWoodsCircle,SuiteE;Alpharetta,GA30005 1-855-647-4363 www.mygenomics.com MGV101/REV 09-16

☐ IunderstandthatImaycontactmyGenomicsviaemailatinfo@mygenomics.comorbyphoneat1-855-647-4363ifIwish

tooptoutoffuturecontactorhaveanyquestionsrelatedtomytestresults.

☐ IunderstandthatsamplesfromresidentsofNewYorkStatewillnotbeincludedinthede-identifiedresearchstudiesdescribedinthis

authorizationandwillnotberetainedformorethan60daysaftertestcompletion,unlessspecificallyauthorizedbymyselectionbelow.

TheauthorizationisoptionalandtestingwillnotbeaffectedifIdonotchecktheboxfortheNewYorkauthorizationlanguage.

☐ InternationalSpecimens:IfmychildorIresideoutsideoftheUnitedStates,Iattestthatbyprovidingasamplefortesting,Iamnotknowinglyviolatinganyexportbanorotherlegalrestrictioninthecountryofmyormychild’sresidence.

☐ PatientConfidentialityandGeneticCounseling:ItisrecommendedthatmychildorIreceivegeneticcounselingbeforeandafterthegenetictest.Furthertestingorconsultationswithahealthcareprovidermaystillbenecessary.Tomaintainconfidentiality,thetestresults

willonlybereleasedtothereferringhealthcareprovider,totheorderinglaboratory,tomeorotherhealthcareprovidersinvolvedinmy

ormychild’sdiagnosisandtreatment,ortoothersasentitledbylaw.TheUnitedStatesFederalGovernmenthasenactedseverallawsthat

prohibitdiscriminationbasedongenetictestresultsbyhealthinsurancecompaniesandemployers.Inaddition,theselawsprohibit

unauthorizeddisclosureofthisinformation.Formoreinformation,IunderstandthatIcanvisitwww.genome.gov/10002077.

PatientAcknowledgement:Byagreeingtothisauthorization,Iacknowledgethefollowing:• 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/GuardianAuthorizationBymysignaturebelow,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’sStatementThistestismedicallynecessaryfortheriskassessment,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


Top Related