7
_________________________________________________________________________________________________________________________ First Name Middle Name Last Name ______________________________________________________________________________________________________________________________________________________________________________________ Street Address ______________________________________________________________________________________________________________________________________________________________________________________ City State Zip Code Home Phone: ________________________________________________________ Gender: Male Female DOB (mm/dd/yyyy): ________________________________ Ancestry: African American Caucasian Hispanic European Middle Eastern Asian Ashkenazi-Jewish Central/South American Other _______________________________________________________ This test is medically necessary for the risk assessment, diagnosis or detection of a disease, illness, impairment, symptom, syndrome or disorder. The results will determine my patient’s medical management and treatment decisions. By my signature below, I indicate that I am the referring physician or authorized health care provider. I have explained the purpose of the test. The patient has been given the opportunity to ask questions and/or seek genetic counseling. The patient has voluntarily decided to have the test performed by myGenomics. ________________________________________________________________ __________________________________________ Medical Professional Signature (required) Date (mm/dd/yyyy) Sign here or on the consent document. I have read the Informed Consent document and give my permission to myGenomics to perform genetic testing as described. I also give permission for my specimen and clinical information to be used in de-identified studies at myGenomics to improve genetic testing and for publication, if appropriate. My name or other personal identifying information will not be used in or linked to the results of any studies and publications. I also give myGenomics permission to inform me in the future about research opportunities, including treatments for the condition in my family. ! Check this box if you want to opt out of research studies. ! Check this box if you do not wish to be contacted. ! Check this box if you are a NY resident and give myGenomics permission to retain any remaining sample longer than 60 days after the completion of testing. ________________________________________________________________________________________ Patient/Guardian Signature Date (mm/dd/yyyy) Billing Type: ! Commercial Insurance ! Medicare ! Medicaid Prior authorization #: _______________________________________________________________________ Please complete the following and attach a copy of the front and back of the patient’s insurance card (include secondary when applicable). _______________________________________________________________________________________________ / ___________________________________________________________________________________________________________ Primary Insurance Carrier ID# Group # Secondary Insurance Carrier ID# Group _______________________________________________________________________________________________ /___________________________________________________________________________________________________________ Name of Insured Person Relationship to Patient Name of Insured Person Relationship to Patient _______________________________________________________________________________________________ / ___________________________________________________________________________________________________________ Insured Date of Birth Start date of coverage Insured Date of Birth Start date of coverage _________________________________________________________________________________________________________________________ Practice Name Provider Name Provider NPI # ______________________________________________________________________________________________________________________________________________________________________________________ Street Address ______________________________________________________________________________________________________________________________________________________________________________________ City State Zip Code Office Phone: __________________________________________ Office Fax: __________________________________________ Email: _____________________________________________________________ Additional Physician or Genetic Counselor to be copied: Name: __________________________________________________________________ Fax #: ____________________________________ PATIENT INFORMATION ORDERING ACCOUNT INFORMATION PHYSICIAN AUTHORIZATION PATIENT AUTHORIZATION BILLING INFORMATION CLIA # 11D2084528 11535 Park Woods Circle, Suite E; Alpharetta, GA 30005 1-855-647-4363 www.mygenomics.com Cancer Test Requisition Form Collection Date (mm/dd/yyyy): ____________________________ Office Use Only: Date Received: ____________________________________________________________ Specimen Type: ! Buccal ! Blood (2 mL in lavender top tube) ! Saliva ! Other _________________________________ MGV101/REV 09-16

Cancer Test Requisition Form - myGenomics€¦ · Cancer Test Requisition Form Collection Date ... , TFG, THSD7B, TP53, ZFHX3, ZNF473 ... AIP, ALK, APC, ATM, BAP1, BLM, BMPR1A, BRCA1

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_________________________________________________________________________________________________________________________

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