MP-10 Genetic Testing for HBOC BRCA Form

Medical Policy Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) Page 1

Policy Number: MP-10 Current Effective Date: 09/06/2019 Original Effective Date: 01/01/2016 Next Review/Revision Date: 09/06/2020 Plans: QUEST Integration (Medicaid), AlohaCare Advantage Plus Special Needs Plan (SNP Medicare)

1. Purpose 1.1 The purpose of this policy is to define medically necessary indications for genetic counseling and genetic testing for Hereditary Breast and Ovarian Cancer (HBOC) Syndrome. It is the intent of this policy to recognize genetic testing for HBOC as appropriate and consistent with good medical practice when performed for the indications listed in this policy.
2. Policy 2.1 Genetic testing for BReast CAncer Susceptibility (BRCA) pathogenic variant for HBOC is considered medically necessary for high risk individuals. This test identifies variants of the BRCA 1/2 genes in order to confirm or rule out an inherited gene mutation that increases lifetime risk for breast or ovarian cancer.7.17 Mutations in BRCA 1 and BRCA 2 genes are thought to account for 5-20% of HBOC cases. Cancer types associated with harmful mutations of the BRCA gene are predominantly breast, ovarian, and fallopian tube cancer.7.10 2.2 BRCA testing is also considered medically when used as an FDA approved companion diagnostic test. 2.3 Mutation in the BRCA gene exhibit an autosomal dominant inheritance pattern where the mutation will be passed from either the mother’s or father’s side of the family.7.18 The risk of breast and/or ovarian cancer increases with the number of affected relatives in the family and the closeness of the relationship, and is affected by the age at which the affected relative was diagnosed.7.16 Once the BRCA gene variant has been identified in a family, testing of at-risk relatives is limited to the identified familial BRCA gene variant.7.16
   2.4 The US Preventive Services Task Force (USPSTF), the American Society of Clinical Oncology (ASCO), and the American College of Obstetrician & Gynecologists (ACOG) highly recommend genetic risk assessment and genetic counseling when testing is offered (i.e., pre-test counseling) and, if indicated after results (i.e., post-test counseling). Genetic counseling (pre and post) is considered medically necessary in appropriately screened individuals. 2.5 Genetic Counseling by Health Professionals a. While not required for Medicare payment under CMS National Coverage Determination (2019), NCCN Guidelines recommend referral to a cancer genetics professional with expertise and experience in cancer genetics prior to genetic testing and after genetic testing.
   Genetic counseling should be conducted by a trained health professional and involved early in the counseling of patients. Trained health professionals include:
3. Genetic counselor (i.e. board-certified genetic counselor [MS and/or CGC])

Medical Policy Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) Page 2

2. Medical geneticist (i.e. board-certified geneticist [MD], board-certified clinical geneticist [PhD])
3. Medical Oncologist
4. Oncology nurse (i.e. licensed advanced practice registered nurse [APRN] in genetics)

5. Other health professional with expertise and experience in cancer genetics

6. Definitions 3.1 Affected individual – A patient or relative of a patient with a cancer diagnosis that is associated with the particular syndrome of concern. For purposes of this policy that is BRCA 1 or BRCA 2. 3.2 Autosomal dominant – Autosomal dominant inheritance refers to genetic conditions that occur when a pathogenic or likely pathogenic variant is present in one copy of a given gene. 3.3 Breast Cancer – For the purpose of this policy, it includes invasive and ductal carcinoma in situ (DCIS) breast cancers. 3.4 Close Blood Relative a. First-degree: Parents, siblings and children. b. Second-degree: Grandparents, aunts, uncles, nieces and nephews, grandchildren and half- siblings on the same side of family. c. Third-degree: Great-grandparents, great-aunts, great uncles, great grandchildren and first cousins on the same side of family. 3.5 Early-onset breast cancer – Breast cancer occurring at the age of 50 years old or younger. 3.6 Founder mutations – specific mutations occurring more often in populations founded by a small ancestral group, including Ashkenazi (Eastern Europe) Jews, French Canadians, and Icelanders. 3.7 Genetic counseling – The process of helping an individual understand and adapt to the medical, psychological and familial indications of genetic contributions to disease. Conducted by a trained health professional, genetic counseling services span the life cycle from preconception counseling to infertility evaluation, prenatal genetic screening and diagnosis, and include predisposition evaluation and genetic diagnosis. 3.8 Gleason scoring – System of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from two to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread. A high Gleason score (≥7) means the cancer tissue is very different from normal and the tumor is more likely to spread. 3.9 Hereditary cancer syndrome – A genetic predisposition to certain types of cancer, often with onset at an early age, caused by inherited mutations in one or more genes. Most hereditary cancer syndromes exhibit autosomal dominant inheritance. 3.10 Limited family history – Patients with fewer than two first- or second-degree female relatives

Medical Policy Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) Page 3

surviving beyond 45 years of age in either lineage. 3.11 Pathogenic variant – A genetic alteration that increases an individual’s susceptibility or predisposition to a certain disease or disorder. 3.12 Two Breast Primaries – Bilateral (contralateral) disease or two or more clearly separate ipsilateral primary tumors either synchronously or asynchronously (Not a primary tumor and a metastasis). 3.13 Triple-negative breast cancer – Any breast cancer that lacks over-expression of three markers: estrogen receptor (ER), progesterone receptor (PR), and HER2/neu. This subtype of breast cancer is clinically characterized as more aggressive and less responsive to standard treatment and is associated with poorer overall patient prognosis. It is diagnosed more frequently with BRCA1 mutations.

4. Procedure
   4.1 Genetic Counseling Criteria a. If the patient meets criteria for HBOC genetic testing (see criteria below), genetic counseling is covered. One pre-test counseling and one post-test counseling visits is included. b. Prior authorization is required for genetic counseling/genetic testing. The patient’s medical record must contain documentation that fully supports the medical necessity for services included within this policy. 4.2 HBOC Genetic Testing Criteria for Quest a. Individual from a family with a known BRCA1/2 pathogenic/likely pathogenic variant, including such variants found on research testing; or b. Personal history of
5. Breast cancer (invasive/DCIS) and one or more of the following: o Diagnosed ≤45 y/o; or o Diagnosed 46-50 y/o with: • An additional breast cancer primary at any age; or • ≥1 close blood relative with breast cancer at any age; or • ≥1 close blood relative with high-grade (Gleason score ≥7) prostate cancer; or • unknown or limited family history; or o Diagnosed ≤60 y with triple-negative breast cancer; or o Diagnosed at any age with: • ≥1 close blood relative with: ▪ breast cancer diagnosed ≤50 y/o; or ▪ ovarian carcinoma; or ▪ male breast cancer; or ▪ metastatic prostate cancer; or ▪ pancreatic cancer; or • ≥2 additional breast cancers at any age in patient and/or in close blood relatives; or

Medical Policy Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) Page 4

• Ashkenazi Jewish ancestry (testing for Ashkenazi Jewish founder-specific pathogenic variant should be performed first); or

2. Male breast cancer; or
3. Prostate cancer (Gleason score ≥7) at any age with: o ≥1 close blood relative with ovarian carcinoma, pancreatic cancer, or metastatic prostate cancer at any age or breast cancer <50 y/o; or o ≥2 close blood relatives with breast or prostate cancer (any grade) at any age; or o Ashkenazi Jewish ancestry (testing for Ashkenazi Jewish founder-specific pathogenic variant should be performed first); or
4. Metastatic prostate cancer (biopsy-proven and/or with radiographic evidence); or
5. Ovarian carcinoma (includes fallopian tube and primary peritoneal cancers); or
6. Pancreatic cancer; or c. Family history only: If no personal history of any of the cancers listed above , but with ≥1 first- or second-degree close blood relative with any of the following:
7. Breast cancer and one or more of the following: o Diagnosed ≤45y/o; or o Diagnosed 46-50 y/o with: • An additional breast cancer primary at any age; or • ≥1 close blood relative with breast cancer at any age; or • ≥1 close blood relative with high-grade (Gleason score ≥7) prostate cancer; or • unknown or limited family history; or o Diagnosed ≤60 y with triple-negative breast cancer; or o Diagnosed at any age with: • ≥1 close blood relative with: ▪ breast cancer diagnosed ≤50 y/o; or ▪ ovarian carcinoma; or ▪ male breast cancer; or ▪ metastatic prostate cancer; or ▪ pancreatic cancer; or • ≥2 additional breast cancers at any age in patient and/or in close blood relatives; or • Ashkenazi Jewish ancestry (testing for Ashkenazi Jewish founder-specific pathogenic variant should be performed first); or
8. Male breast cancer
9. Prostate cancer (Gleason score ≥7) at any age with: o ≥1 close blood relative with ovarian carcinoma, pancreatic cancer, or metastatic prostate cancer at any age or breast cancer <50 y/o; or o ≥2 close blood relatives with breast or prostate cancer (any grade) at any age; or o Ashkenazi Jewish ancestry (testing for Ashkenazi Jewish founder-specific pathogenic variant should be performed first); or
10. Metastatic prostate cancer (biopsy-proven and/or with radiographic evidence and includes distant metastasis and regional bed or nodes), or
11. Ovarian carcinoma (includes fallopian tube and primary peritoneal cancers), or
12. Pancreatic cancer, or

Medical Policy Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) Page 5

d. Tumor profiling on any tumor type that detected a BRCA 1/2 pathogenic variant in the absence of germline pathogenic variant analysis; or e. Companion diagnostic: For FDA approved indications for BRCA 1/2 testing is medically necessary. Testing to determine treatment eligibility does not require genetic counseling. The following criteria must be met for eligibility:

1. Patient has a diagnosis of cancer; and
2. The specific therapeutic is FDA-approved for the patient’s condition; and
3. Treatment eligibility is dependent upon BRCA 1/2 testing. Examples include: o Breast cancer: • Lynparza (olaparib) – NDA 208558 • Talzenna (talazoparib) – NDA 211651 o Ovarian cancer: • Lynparza (olaparib) – NDA 208558 • Rubraca (rucaparib) – NDA 209115
4. Documentation of planned treatment must be submitted with authorization request. 4.3 HBOC Genetic testing Criteria for Medicare a. Personal history of breast, ovarian, pancreatic, or prostate cancer from a family with a known BRCA1/2 pathogenic/likely pathogenic variant. BRCA-related ovarian cancers are associated with epithelial, non-mucinous histology. b. Personal history of:
5. Breast cancer: o Diagnosed ≤45 y/o, or o Diagnosed at ≤50 y/o with: • An additional breast cancer primary, or • ≥1 close blood relative with breast cancer at any age, or • ≥1 close blood relative with prostate cancer (Gleason score ≥7), or • An unknown or limited family history, or o Triple negative breast cancer diagnosed ≤60 y/o; or o Breast cancer diagnosed at any age, and • ≥1 close blood relative with breast cancer ≤50 y/o, or • ≥1 close blood relative with ovarian cancer at any age, or • ≥1 close blood relative with metastatic prostate cancer or pancreatic cancer at any age, or • ≥2 additional breast cancer at any age in patient and/or in close blood relative, or
   • A close male blood relative with breast cancer, or • Ashkenazi Jewish ancestry, or
6. Male breast cancer, or
7. Prostate cancer (Gleason score ≥7) at any age with: o ≥1 close blood relative with ovarian cancer at any age, or o ≥1 close blood relative with breast cancer ≤50 y/o, or o ≥1 close blood relative with pancreatic cancer at any age, or o ≥1 close blood relative with metastatic prostate cancer at any age, or o ≥2 close blood relative with breast cancer and/or pancreatic cancer and/or prostate

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cancer (Gleason score ≥7 or metastatic) at any age, or o Ashkenazi Jewish ancestry, or

4. Metastatic prostate cancer (biopsy-proven and/or radiographic evidence); or
5. Ovarian carcinoma (or fallopian tube or primary peritoneal); or
6. Pancreatic cancer at any age; or c. Tumor profiling on any tumor type that detected a BRCA 1/2 pathogenic variant in the absence of germline pathogenic variant analysis; or d. Companion diagnostic: For FDA approved indications, BRCA 1/2 testing is medically necessary. Testing to determine treatment eligibility does not require genetic counseling. The following criteria must be met for eligibility:
7. Patient has a diagnosis of cancer; and
8. The specific therapeutic is FDA-approved for the patient’s condition; and
9. Treatment eligibility is dependent upon BRCA 1/2 testing. Examples include: o Breast cancer: • Lynparza (olaparib) – NDA 208558 • Talzenna (talazoparib) – NDA 211651 o Ovarian cancer: • Lynparza (olaparib) – NDA 208558 • Rubraca (rucaparib) – NDA 209115

10. Documentation of planned treatment must be submitted with authorization request.

11. Limitations 5.1 Genetic counseling and/or genetic testing is not covered: a. For Medicare only –Testing of a Medicare eligible individual with no personal history of breast cancer (invasive/DCIS), ovarian cancer (fallopian tube and primary peritoneal), pancreatic, or prostate cancer regardless of family history. b. For Quest only - Individuals with no personal or family history of cancer. c. Genetic testing for the medical management of individuals who are not current AlohaCare patients. d. If a BRCA gene variant has been identified in a family, testing of at-risk relatives is limited to the identified familial BRCA gene variant (pathogenic, or likely pathogenic). AlohaCare will only cover the targeted single site analysis genetic test, not a full analysis (i.e. testing for the mutation that has been identified in the family). e. Repeat BRCA testing. BRCA genetic testing is limited to once-in-a-lifetime. If a patient has been previously tested for BRCA 1 and BRCA 2, repeat testing as a companion diagnostic (e.g. prior to Lynparza therapy) is not reasonable and necessary. f. Genetic testing for BRCA 1 and BRCA 2 mutations for assessment of risk of other cancers including but not limited to pancreatic, prostate and colon cancer. g. Testing of individuals under 18 years of age. h. Testing family members for a variant of unknown significance.

    5.2 Genetic Testing Considerations a. Individuals with unknown or limited family history/structure may have an underestimated probability of familial pathogenic/likely pathogenic variant detection.

Medical Policy Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) Page 7

1. BRCA-testing for an adopted individual with breast cancer diagnosed ≤50 y/o, which is suspicious of being a BRCA-related cancer is covered.
2. Individuals with limited family history/structure, may also be eligible for BRCA gene testing. Similar to all testing, these situations require explanation of medical necessity for BRCA testing in the patient’s medical record, and documentation of genetic counseling prior to BRCA testing. b. Testing should begin with a relative who has had a BRCA-related cancer, including male relatives, before testing individuals without cancer.

3. Testing for Ashkenazi Jewish founder-specific mutations should be performed first.
   Comprehensive BRCA 1/2 testing may be considered if ancestry also includes non- Ashkenazi Jewish relatives or if any of the other BRCA-related criteria are met. c. Patients who had allogeneic bone marrow transplant should not have molecular genetic testing via blood or buccal samples. The test is unreliable due to contamination by donor DNA. If available, DNA should be extracted from a fibroblast culture. If this source of DNA is not possible, buccal samples can be considered, subject to the risk of donor DNA contamination.

4. Coding Information The following medical codes are relevant codes for diagnosis and procedures HBOC genetic testing and for informational purposes only. All the medical codes listed in this policy do not constitute or imply benefit coverage or provider reimbursement. ICD‐10‐CM Covered

   Description C25.0-C25.9 Malignant neoplasm of pancreas C48.1 Malignant neoplasm of specified parts of peritoneum C50.011- C50.029 Malignant neoplasm of nipple and areola [female and male] C50.111- C50.129 Malignant neoplasm of central portion of breast [female and male] C50.211- C50.229 Malignant neoplasm of upper‐inner quadrant of breast [female and male] C50.311- C50.329 Malignant neoplasm of lower‐inner quadrant of right breast [female and male] C50.411- C50.429 Malignant neoplasm of upper‐outer quadrant of breast [female and male] C50.511- C50.529 Malignant neoplasm of lower‐outer quadrant of breast [female and male] C50.611- C50.629 Malignant neoplasm of axillary tail of breast [female and male] C50.811- C50.829 Malignant neoplasm of overlapping sites of breast [female and male] C50.911- C50.929 Malignant neoplasm of unspecified site of breast [female and male] C56.0-C56.9 Malignant neoplasm of ovary. Use additional code to identify any functional activity

Medical Policy Genetic Counseling and Testing for Hereditary Breast and Ovarian Cancer Syndrome (HBOC) Page 8

C57.00-C57.02 Malignant neoplasm of fallopian tube C61 Malignant neoplasm of prostate. Use additional code to identify: hormone sensitivity status (Z19.1-Z19.2), rising PSA following treatment for malignant neoplasm of prostate (R97.21) D05.00-D05.02 Lobular carcinoma in situ of breast D05.10-D05.12 Intraductal carcinoma in situ of breast D05.80-D05.82 Other specified type of carcinoma in situ of breast Z80.3 Family history of malignant neoplasm of breast. Conditions classifiable to C50. Z80.41 Family history of malignant neoplasm of ovary Z80.42 Family history of malignant neoplasm of prostate Z85.07 Personal history of malignant neoplasm of pancreas Z85.3 Personal history of malignant neoplasm of breast. Conditions classifiable to C50. Z85.43 Personal history of malignant neoplasm of ovary Z85.46 Personal history of malignant neoplasm of prostate

HCPCS/CPT Covered Description 81162-81167 BRCA1 (BRCA1, DNA repair associated), BRCA2 (DNA repair associated) (e.g., hereditary breast and ovarian cancer) Gene analysis.
Do not report 81162 in conjunction with 81163- 81167, 81216, 81217, 81432. 81212 BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants 81215-81217 BRCA1 (breast cancer 1) (e.g., hereditary breast and ovarian cancer) gene analysis; 96040 Medical genetics and genetic counseling services, each 30 minutes face‐to‐face with patient/family S0265 Genetic counseling, under physician supervision, each 15 minutes

HCPCS/CPT Not Covered Description 81432 Hereditary breast cancer‐related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 14 genes, including ATM, BRCA1, BRCA2, BRIP1, CDH1, MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, and TP53 81445 Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5‐50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed 81455 Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA,

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PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed 81479 Unlisted molecular pathology procedure

7. References/Resources 7.1 American College of Obstetricians and Gynecologists (ACOG). Hereditary Cancers Syndromes and Risk Assessment. Committee Opinion No. 634. 2015 Jun. (Reaffirmed 2017). 7.2 American College of Obstetricians and Gynecologists (ACOG). Family History as a Risk Assessment Tool. Committee Opinion No. 478. 2011 March (Reaffirmed 2018). 7.3 American Society of Clinical Oncology. Policy Statement Update: Genetic and Genomic Testing for Cancer Susceptibility. Journal of Clinical Oncology. 2015 Nov. Vol 33. No 31. 7.4 Atchley D, Albarracin C, et al. Clinical and Pathologic Characteristics of Patients with BRCA- Positive and BRCA-Negative Breast Cancer. Journal of Clinical Oncology26, no.26. (2008) 4282-4288. 7.5 Center for Disease Control and Prevention (CDC). Hereditary Breast and Ovarian Cancer. Page last reviewed: 2018 Oct. Accessed on 7/7/2019.. 7.6 Chen S, Iversen ES, et al. Characterization of BRCA1 and BRCA2 Mutations in a Large United States Sample. J Clin Oncol. 2006 Feb 20; 24(6):863-871. Doi: 10.1200/JCO.2005.03.6772. 7.7 CMS National Coverage Policy. Local Coverage Determination (LC): MolDX: BRCA1 and BRCA2 Genetic Testing (L36161). Noridian Healthcare Solutions. 2019 Jan. 7.8 Evans DG, Shenton A, et al. Penetrance estimates for BRCA1 and BRCA2 based on genetic testing in a Clinical Cancer Genetics service setting: Risks of breast/ovarian cancer quoted should reflect the cancer burden in the family. BMC Cancer. 2008;8:155. 7.9 Lindor NM, McMaster ML, et al. National Cancer Institute, Division of Cancer Prevention, Community Oncology and Prevention Trials Research Group. Concise handbook of familial cancer susceptibility syndromes: second edition. J Natl Cancer Inst Monogr.2008:1-9. 7.10 Moyer VA. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related
   Cancer in Women: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern
   Med. 2014;160(4):271-281. 7.11 National Cancer Institute. BRCA Mutations: Cancer Risk and Genetic Testing. Accessed on
   7/17/2019. 7.12 National Cancer Institute. Cancer Stat Facts: Female Breast Cancer. SEER Cancer Statistics
   Review. Accessed on 7/17/2019. 7.13 National Cancer Institute. Cancer Stat Facts: Ovarian Cancer. SEER Cancer Statistics Review.
   Accessed on 7/17/2019. 7.14 National Cancer Institute. State Cancer Profiles. Quick Profiles: Hawaii. Accessed on 7/17/2019. 7.15 National Cancer Institute. Pathogenic variant. NCI Dictionary of Genetics Terms. Accessed on
   7/25/2019. 7.16 National Comprehensive Cancer Network (NCCN). Genetic/Familial High-Risk Assessment
   Breast and Ovarian. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)
   Version 3.2019. 2019Jan. 7.17 National Institutes of Health (NIH). What is genetic testing? Genetics Home Reference. Accessed

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on 7/25/2019. 7.18 Petrucelli N, Daly MB, et al. BRCA- and BRCA2- Associated Hereditary Breast and Ovarian
Cancer. U.S. National Library of Medicine. Gene Reviews. 1998 Sep (Updated 2016 Dec).
7.19 Peshkin B, Alabek M, et al. BRCA1/2 mutations and triple negative breast cancers. National
Institute of Health. Breast Dis. 2010; 32(0). Doi: 10.3233/BD-2010-0306. 7.20 Tandy-Conner S, Guiltinan J, et al. False-positive results released by direct-to-consumer genetic
tests highlight the importance of clinical confirmation testing for appropriate patient care. Genet
Med 2018 Mar 22. 7.21 Tyndel S, Clements A, et al. Mammographic screening for young women with a family history
of breast cancer: knowledge and views of those at risk. British Journal of Cancer99. (2008)
1007-1012. 7.22 U.S. Food & Drug Administration. List of Cleared or Approved Companion Diagnostic Devices
(In Vitro and Imaging Tools). Current as of 06/20/2019. Accessed on 7/30/2019. 7.23 Walsh T, Lee M, et al. Detection of inherited mutations for breast and ovarian cancer using
genomic capture and massively parallel sequencing. Proceedings of the National Academy of
Sciences of the United States of America (PNAS). 2010 Jul. Vol 107: no.28 (12629-12633). 7.24 Weitzel JN, Lagos VI, et al. Limited Family Structure and BRCA Gene Mutation Status in
Single Cases of Breast Cancer. The Journal of the American Medical Association (JAMA).
2007;297(23):2587-2595.

Review/Revision Date: 09/06/2020 - Retired