Understanding a - Amazon S3

Understanding a Positive Result

A guide to understanding risk and taking action

PART ONE:

1 Understanding a Positive Result Your test result may include three parts: your Genetic Test Result, your breast cancer riskScore?

(if applicable), and your Clinical History Analysis.

Genetic Test Result

A. Your Myriad myRisk? Hereditary Cancer result summary is located on the first page of your report. It will look similar to the example shown to the right. If you received an POSITIVE myRisk Hereditary Cancer result it means:

1. Your myRisk Genetic Result is POSITIVE. You tested positive for a mutation in one or more genes. One or more of your genes that were passed down through your family is altered, or carries a genetic mutation, which increases your risk for one or more hereditary cancers. This mutation(s) is considered CLINICALLY SIGNIFICANT and changes to your medical management may be appropriate.

2. Your result may contain a breast cancer riskScore?. If the riskScore was performed, details will be provided on the following page of your Genetic Test Result (see E.)

3. Your result will contain a Clinical History Analysis. This analysis was based on personal clinical risk factors and the cancer family history you reported to your provider. If the analysis identified any modified medical management, an orange asterisk will appear. A summary of medical management recommendations based on leading medical society guidelines will be provided in the myRisk Management Tool section of your report.

A B C

REPORT EXAMPLE

Integrated BRACAnalysis? with Myriad myRisk? Hereditary Cancer

myRisk Genetic Result

RECEIVING HEALTHCARE PROVIDER Test HCP, MD Test Medical Center 123 Main St Testville, TX 55555

SPECIMEN Specimen Type: Draw Date: Accession Date: Report Date:

Blood Aug 02, 2018 Aug 02, 2018 Aug 03, 2018

PATIENT

Name:

Pt Last Name,

Pt First Name

Date of Birth: Aug 02, 1981

Patient ID: Patient id

Gender:

Female

Accession #:

Requisition #:

GENETIC RESULT: POSITIVE - CLINICALLY SIGNIFICANT MUTATION IDENTIFIED

Note: "CLINICALLY SIGNIFICANT," as defined in this report, is a genetic change that is associated with the potential to alter medical intervention.

BREAST CANCER RISKSCORETM: REMAINING LIFETIME RISK 20.0%

This level of risk is at or above 20% threshold for consideration of modified medical management. See riskScoreTM Interpretation Section for more information.

CLINICAL HISTORY ANALYSIS: BEYOND THE GENETIC RESULT, NO MODIFIED MANAGEMENT GUIDELINES IDENTIFIED BASED ON THE CLINICAL HISTORY PROVIDED

Other clinical factors may influence individualized management. This analysis may be incomplete if details about cancer diagnoses, ages, family relationships or other factors were omitted or ambiguous.

GENE MLH1

MUTATION

c.XXXXXX Heterozygous

INTERPRETATION

High Cancer Risk This patient has Lynch syndrome/Hereditary Non-Polyposis Colorectal Cancer (HNPCC).

DETAILS ABOUT: MLH1 c.XXXXXX: XXXXXX; (aka: XXXXXX)

Functional Significance: Suspected Deleterious - Abnormal Protein Production and/or Function The heterozygous germline MLH1 mutation c.XXXXXX is located 3 nucleotides upstream of exon X. This mutation has been shown to segregate with cancer (Loader S et al. Genetic Testing 2005, 9:313-319; Myriad internal data), and shows strong association with more severe personal and family history of cancer, typical for individuals with an HNPCC-associated deleterious mutation (Myriad internal data; Goldgar DE et al, Hum Mutat, 2008, 29:1265-1272; Easton DF et al, Am J Hum Genet, 2007, 81:873-883).

Clinical Significance: High Cancer Risk This mutation has been shown to segregate with cancer (Loader S et al. Genetic Testing 2005, 9:313-319; Myriad internal data), and shows strong association with more severe personal and family history of cancer, typical for individuals with an HNPCC-associated deleterious mutation (Myriad internal data; Goldgar DE et al, Hum Mutat, 2008, 29:1265-1272; Easton DF et al, Am J Hum Genet, 2007, 81:873-883). This mutation is associated with increased cancer risk and should be regarded as clinically significant.

ADDITIONAL FINDINGS: NO VARIANT(S) OF UNCERTAIN SIGNIFICANCE (VUS) IDENTIFIED

Details About Non-Clinically Significant Variants: All individuals carry DNA changes (i.e., variants), and most variants do not increase an individual's risk of cancer or other diseases. When identified, variants of uncertain significance (VUS) are reported. Likely benign variants (Favor Polymorphisms) and benign variants (Polymorphisms) are not reported and available data indicate that these variants most likely do not cause increased cancer risk. Present evidence does not suggest that non-clinically significant variant findings be used to modify patient medical management beyond what is indicated by the personal and family history and any other clinically significant findings.

Variant Classification: Myriad's myVisionTM Variant Classification Program performs ongoing evaluations of variant classifications. In certain cases, healthcare providers may be contacted for more clinical information or to arrange family testing to aid in variant classification. When new evidence about a variant is identified and determined to result in clinical significance and management change, that information will automatically be made available to the healthcare provider through an amended report.

? 2018 Myriad Genetics, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 1-800-469-7423 FX: 801-584-3615 The format and contents of this report are proprietary and may not be copied or used without permission, except for purposes of diagnosing, counseling and treating the patient identified in the report and members of his or her family. Myriad, Myriad myRisk, riskScore, BRACAnalysis, COLARIS, myVision and their respective logos are either trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other jurisdictions.

myRisk Genetic Result: Page 1 of 3

B. Your report provides you with detailed information about your specific gene mutation and your increased risk for associated cancers. With this information, you and your healthcare provider can develop a medical management plan that is right for you.

C. In addition to your positive result, your testing may have found one or more "Variants of Uncertain Significance (VUS)." A VUS is not currently known to be associated with an increased cancer risk. Myriad has made a lifetime commitment to understanding the nature of these variants. If new evidence about a variant is identified, that information will be made available to your healthcare provider who will then contact you with updated information. It is important to understand that medical management decisions should not be based on the VUS result.

Positive result with SINGLE SITE testing: If a member of your family has tested positive for a mutation, your provider may have ordered testing for only that mutation to see if you carry it. This is known as single site testing. If you get a positive single site test result, you DO carry the mutation that is in your family and should discuss relevant changes to your medical management with your healthcare provider. Because single site testing does not look for other mutations or assess risk from family history, there are limitations to the information. Positive results on single site tests will include a myRisk Management Tool that is specific ONLY to your gene mutation.

D. You can find a list of all the genes tested in the Genes Analyzed section.

E. If the riskScore? was performed, this page of your Genetic Test Result will contain details of the analysis. This page displays an estimate of your remaining lifetime risk for breast cancer as well as your risk over the next five years. You can compare your risk to the general population using the graph provided. If the analysis identified any modified medical management based on your riskScore, an orange asterisk will appear next to your score. A summary of medical management recommendations based on leading medical society guidelines will be provided in the myRisk Management Tool section of your report.

F. The Clinical and Cancer Family History Information Page displays the information regarding your clinical history and personal and cancer family history you reported.

REPORT EXAMPLE

myRisk Genetic Result Name: Pt Last Name, Pt First Name

DOB: Aug 02, 1981

Accession #: Report Date: Aug 03, 2018

ADDITIONAL INFORMATION

D

GENES ANALYZED

Unless otherwise noted sequencing and large rearrangement analyses were performed on the following genes:

APC, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, EPCAM (large rearrangement only), MLH1, MSH2, MSH6, MUTYH, NBN, PALB2, PMS2, PTEN, RAD51C, RAD51D, SMAD4, STK11, TP53. Sequencing was performed for select regions of POLE and POLD1, and large rearrangement analysis was performed for select regions of GREM1 (see technical specifications).

** Other genes not analyzed with this test may also be associated with cancer.

Indication for Testing: It is our understanding that this individual was identified for testing due to a personal or family history suggestive of a hereditary predisposition for cancer.

Associated Cancer Risks and Clinical Management: Please see the "myRisk Management Tool" associated with this report for a summary of cancer risk and professional society medical management guidelines that may be useful in developing a plan for this patient based on test results and reported personal/family history, if applicable. Testing of other family members may assist in the interpretation of this patient's test result.

Analysis Description: The Technical Specifications summary (. com/documents-and-forms/technical-specifications/) describes the analysis, method, performance, nomenclature, and interpretive criteria of this test. Current testing technologies are unable to definitively determine whether a variant is germline or somatic in origin, which may significantly impact risk estimates and medical management; therefore, these results should be correlated with this patient's personal and family history. The interpretation of this test may also be impacted if the patient has a hematologic malignancy or an allogeneic bone marrow transplant.

CLASSIFICATION DISCLAIMER

THE CLASSIFICATION AND INTERPRETATION OF ALL VARIANTS IDENTIFIED IN THIS ASSAY REFLECTS THE CURRENT STATE OF MYRIAD'S SCIENTIFIC UNDERSTANDING AT THE TIME THIS REPORT WAS ISSUED. VARIANT CLASSIFICATION AND INTERPRETATION MAY CHANGE FOR A VARIETY OF REASONS, INCLUDING BUT NOT LIMITED TO, IMPROVEMENTS TO CLASSIFICATION TECHNIQUES, AVAILABILITY OF ADDITIONAL SCIENTIFIC INFORMATION, AND OBSERVATION OF A VARIANT IN MORE PATIENTS.

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Breast Cancer

BrriesakSstcoCraenTcMe: r riskScoreTM

2203.06%%

RESULT: 20.0% Remaining Lifetime Risk for Breast Cancer

RESULT: 23.60%.7%Re5m-Yaeinainr gRiLsikfefotirmBereRaisstkCfoarncBerreast Cancer 0.8% 5-Year Risk for Breast Cancer

General Population

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Threshold

13.1%

20% Risk Threshold

This Patient

23.6%

Average Risk

Above Average Risk

? 2018 Myriad Genetics, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 1-800-469-7423 FX: 801-584-3615

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The5format and con1t0ents of this rep1o5rt are proprieta2r0y and may not 2b5e copied or us3e0d without perm3is5sion, except fo4r0purposes of 45

diagnosing, counseling and treating the patient identified in the report and members of his or her family. Myriad, Myriad myRisk,

riskScore, BRACAnalysis, COLARIS, myVision and their respective logos are either trademarks or registered trademarks of Myriad

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Name 1981

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This Authorized Signature pertains to this laboratory report:

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? 2018 Myriad Genetics, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 1-800-469-7423 FX: 801-584-3615

The format and contents of this report are proprietary a- nAMdgameteaornyfaonlnoAstuebntet copied or used without perNm/AisOsvioarnia,nexcept for purposes-oNf umber of year4s5ago ended

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diagnosing, counseling and treating the patient riskScore, BRACAnalysis, COLARIS, myVision

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PERSONAL / FAMILY CANCER HISTORY SUMMARY

The clinical information displayed here was provided by a qualified healthcare provider on the Test Request Form and other documents, and was not verified by Myriad. FAFtMhaemISLilpyYemcMiefimcEabtMeiornsBsliEsfoteRr dPearss"oontahl/eFra"mairlye HnoisttoinrcyluAdneadlyisnisaaTtyhrCettrp-ACs:uN//zniCcekwEb.Rmreya/rsiatCdcpaLrnoIcN.ecroICmris/AkdoeLcsutDimmIeaAntetGso-aNrnodOt-hfSeorrImpSesr/tseocnhanl/ifcaaml-silpyeAhciisGfitcoEarytioaAnsssT/e.sDsmIAenGtsN. FOorSmISore information see

F

Patient

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Mother

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NUMBER OF PATIENT'S FEMALE RELATIVES

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0 Sisters

2 Maternal Aunts

2 Paternal Aunts

1

The clinical information displayed here was provided by a qualified healthcare provider on the Test Request Form and other documents, and was not verified by Myriad. Family members listed as "other" are not included in a Tyrer-Cuzick breast cancer risk estimate or other personal/family history assessments. For more information see the Specifications for Personal/Family History Analysis at . The accuracy of the information provided in the Clinical and Cancer Family History Information section of the report may significantly affect the accuracy of breast cancer risk estimates provided based on either Tyrer-Cuzick or riskScoreTM.

riskScoreTM is only calculated for women who meet the eligibility criteria listed below. riskScoreTM is not valid, and may significantly over- or under-estimate breast

cancer risk for a woman who does not meet these criteria: 1) ancestry is exclusively White/Non-Hispanic (includes Ashkenazi Jewish), 2) age is 85 or younger, 3) no personal history of breast cancer, LCIS, hyperplasia (with or without atypia), or a breast biopsy with unknown results, 4) no known mutation in a breast cancer risk

gene has been found in the woman or any of her relatives, and 5) the sample was submitted with a current Test Request Form and the ordering healthcare provider has not determined that riskScoreTM is inappropriate for the patient.

? 2017 Myriad Genetics, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 1-800-469-7423 FX: 801-584-3615 The format and contents of this report are proprietary and may not be copied or used without permission, except for purposes of diagnosing, counseling and treating the patient identified in the report and members of his or her family. Myriad, Myriad myRisk, riskScore, BRACAnalysis, COLARIS, myVision and their respective logos are either trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other jurisdictions.

? 2018 Myriad Genetics, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 1-800-469-7423 FX: 801-584-3615 The format and contents of this report are proprietary and may not be copied or used without permission, except for purposes of diagnosing, counseling and treating the patient identified in the report and members of his or her family. Myriad, Myriad myRisk, riskScore, BRACAnalysis, COLARIS, myVision and their respective logos are either trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other jurisdictions.

Clinical & Family History Information: Page 1 of 1

Clinical Information: Page 1 of 1

If you have additional questions about your result please contact your healthcare provider. Myriad's Medical Services team is also available to help:

(800) 469-7423 x3850 / helpmed@

2

PART TWO:

Understanding a Positive Result

Your future risk of cancer is influenced by your Genetic Test Result, your personal clinical history and your family history of cancer. The myRisk Management Tool provides a summary of your future risks based on your genetic result and the information provided to Myriad, but additional risk factors should be discussed with your provider.

myRisk Management Tool

G. Cancers Associated with a Positive myRisk Genetic Result. If you received a Positive myRisk? Genetic Result, you will find a table of cancer risks specific to your gene mutation on the first page of the myRisk Management Tool below the genetic test result summary information. An additional table may include ranges of risks for these cancers as compared to the general population (see J.)

Cancers on these tables may be in red or orange. Red indicates that the increase in risk is significantly more than the general population. Orange indicates that the risk is elevated and there may not be an exact percentage known at this time.

H. You may receive a riskScore?. riskScore is only calculated for women under age 85, of solely White / Non-Hispanic and/or Ashkenazi Jewish ancestry, without a personal history of breast cancer, LCIS, hyperplasia, atypical hyperplasia, or a breast biopsy with unknown results. This score is calculated using both genetic and non-genetic factors that may be shared within your family. It is important to note that if your genetic mutation has an increase in risk for breast cancer, then your breast cancer risk will be defined only by your myRisk Genetic Result. However if your gene mutation is not known to carry a risk for breast cancer, then your healthcare provider may use riskScore to understand your risk for breast cancer. If your riskScore is calculated to be 20% or higher, modified medical management recommendations will be summarized later in the report.

I. If you are a woman who has never been diagnosed with breast cancer and have no relatives with a known genetic mutation you will also receive a Tyrer-Cuzick Risk Calculation. Tyrer-Cuzick is a model used to predict a woman's risk of developing breast cancer which was developed by leading researchers. TyrerCuzick takes into consideration your family history of cancer and other personal clinical risk factors. If your Tyrer-Cuzick Risk Calculation is 20% or higher, modified medical management recommendations will be summarized later in the report.

H I

REPORT EXAMPLE

Integrated BRACAnalysis? with Myriad myRisk? Hereditary Cancer

myRisk Management Tool

RECEIVING HEALTHCARE PROVIDER Test HCP, MD Test Medical Center 123 Main St Testville, TX 55555

SPECIMEN Specimen Type: Draw Date: Accession Date: Report Date:

Blood Aug 02, 2018 Aug 02, 2018 Aug 03, 2018

PATIENT

Name:

Pt Last Name,

Pt First Name

Date of Birth: Aug 02, 1981

Patient ID: Patient id

Gender:

Female

Accession #:

Requisition #:

GENETIC RESULT: POSITIVE - CLINICALLY SIGNIFICANT MUTATION IDENTIFIED

Note: "CLINICALLY SIGNIFICANT," as defined in this report, is a genetic change that is associated with the potential to alter medical intervention.

BREAST CANCER RISKSCORETM: REMAINING LIFETIME RISK 20.0%

This level of risk is at or above 20% threshold for consideration of modified medical management. See riskScoreTM Interpretation Section for more information.

CLINICAL HISTORY ANALYSIS: BEYOND THE GENETIC RESULT, NO MODIFIED MANAGEMENT GUIDELINES IDENTIFIED BASED ON THE CLINICAL HISTORY PROVIDED

Other clinical factors may influence individualized management. This analysis may be incomplete if details about cancer diagnoses, ages, family relationships or other factors were omitted or ambiguous.

GENE

MUTATION

THIS GENETIC TEST RESULT IS ASSOCIATED WITH THE FOLLOWING CANCER RISKS:

MLH1

c.XXXXXX Heterozygous

HIGH RISK: Colorectal, Endometrial, Ovarian, Gastric

ELEVATED RISK: Pancreatic

G

BREAST CANCER RISKSCORETM

THIS BREAST CANCER RISKSCORETM IS ASSOCIATED WITH THE FOLLOWING CANCER RISKS:

At or above 20%

ELEVATED RISK: Female Breast

Please see the Genetic Test Result for more details on any variant(s) detected in this patient, including variant classification information.

ADDITIONAL FINDINGS: NO VARIANT(S) OF UNCERTAIN SIGNIFICANCE (VUS) IDENTIFIED

TYRER-CUZICK BREAST CANCER RISK CALCULATION

REMAINING LIFETIME BREAST CANCER RISK: 11.5%

5-YEAR BREAST CANCER RISK: 0.4%

The Tyrer-Cuzick breast cancer risk estimate is not calculated if one or more of the following conditions apply: the woman is known to carry a mutation in a gene associated with breast cancer risk, age is 85 or older, if the sample was submitted with a version of the Test Request Form that does not include all of the fields required to collect the clinical information used in the calculation, or if the provider indicates on the Test Request Form that the Tyrer-Cuzick calculation is not appropriate for the patient. Version 7.02 of the Tyrer-Cuzick model was used for this risk estimate. Tyrer-Cuzick model Versions 7.02 and 8.0 are available for download at the EMS-Trials website, .

REPORT EXAMPLE

? 2018 Myriad Genetics, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 1-800-469-7423 FX: 801-584-3615

The format and contents of this report are proprietary and may not be copied or used without permission, except for purposes of

myRisk Management Tool diagnosing, counseling and treating the patient identified in the report and members of his or her family. Myriad, Myriad myRisk,

riskScore, BRACAnalysis, COLARIS, myVision and their respective logos are either trademarks or registered trademarks of Myriad

Genetics, Inc. in the United States andNoathmeer:juPrtisLdaicsttioNnasm. e, Pt First Name

DOB: Aug 02, 1981

Accessiomn y#R: isk Management TRooelp: oPrat gDeat1e:oAf u8g 03, 2018

CANCER TYPE

OVERALL CANCER RISK (LYNCH CANCERS) Risk for a second Lynch-related cancer after a first cancer diagnosis OVARIAN To age 70

CANCER RISK Increased risk

RISK FOR GENERAL POPULATION

NA

RELATED TO MLH1

4%-12%

0.7%

MLH1

GASTRIC To age 70

6%-13%

0.4%

MLH1

SMALL BOWEL To age 70

3%-6%

0.1%

MLH1

J

URINARY TRACT To age 70

PANCREATIC To age 70

5%-7% 1%-6%

0.7% 0.5%

MLH1 MLH1

HEPATOBILIARY TRACT To age 70

1.4%-4%

0.5%

MLH1

CENTRAL NERVOUS SYSTEM To age 70

1%-3%

0.4%

MLH1

SEBACEOUS NEOPLASMS To age 70

1%-9%

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