CurrentRegence BlueCross BlueShieldPolicy 23

Single-nucleotide Variants (SNVs) to Predict Risk of Nonfamilial Breast Cancer

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This policy governs coverage of commercially available tests that combine single-nucleotide variants to estimate an individual's risk of nonfamilial breast cancer. Testing for SNVs and named SNV-based breast cancer risk assays is considered investigational for all indications.

Policy Summary

PayerRegence BlueCross BlueShield

PolicySingle-nucleotide Variants (SNVs) to Predict Risk of Nonfamilial Breast Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSeptember 1, 2026

Last ReviewJul 1, 2026

Next Review DateMay 1, 2027

Key ActionDo not expect coverage for SNV testing performed to predict an individual's breast cancer risk because the service is considered investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalSNV breast cancer risk testing coverage

4Named investigational assays

InsufficientEvidence for clinical utility

0FDA-approved or cleared SNV risk tests

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CurrentRegence BlueCross BlueShieldPolicy 23

Single-nucleotide Variants (SNVs) to Predict Risk of Nonfamilial Breast Cancer

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Sign up for regence Policy 23 alerts

Get alerted when Policy 23 changes without checking for updates manually.

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Policy Summary

PayerRegence BlueCross BlueShield

PolicySingle-nucleotide Variants (SNVs) to Predict Risk of Nonfamilial Breast Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSeptember 1, 2026

Last ReviewJul 1, 2026

Next Review DateMay 1, 2027

Key ActionDo not expect coverage for SNV testing performed to predict an individual's breast cancer risk because the service is considered investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalSNV breast cancer risk testing coverage

4Named investigational assays

InsufficientEvidence for clinical utility

0FDA-approved or cleared SNV risk tests

Coverage Criteria

Not covered as investigational

The following services are considered investigational.

Investigational SNV-based testing: Testing for one or more single-nucleotide variants (SNVs) to predict an individual's risk of breast cancer.

Investigational for the stated purpose.

Named breast cancer risk assays: OncoVue, GeneType, BREVAGen, and BREVAGen plus breast cancer risk tests, including use as a method of estimating an individual's risk for developing breast cancer.

Investigational for all indications.

SNV panels for nonfamilial breast cancer risk prediction

The evidence review does not support routine clinical use.

Insufficient evidence for clinical use: SNV-based breast cancer risk panels and models have not demonstrated sufficient analytic validation, clinical discrimination, or clinical utility to inform individualized care or population screening.

Performance in intended-use populations remains uncertain; long-term prospective studies with large sample sizes are needed.

Commercial SNV risk tests

Evidence for specific commercial tests remains insufficient.

OncoVue and BREVAGen Plus: Available evidence does not establish that risk estimates from OncoVue or BREVAGen Plus change management decisions or improve patient outcomes in asymptomatic individuals.

Reported improvements in risk prediction may be modest, and management implications are unclear.

SNV testing to predict nonfamilial breast cancer risk

The following testing is considered investigational.

Investigational SNV breast cancer risk testing: SNV panel tests or clinical-SNV genetic tests used to predict breast cancer risk, including but not limited to OncoVue and BREVAGen plus.

Insufficient evidence demonstrates that testing guides treatment decisions or improves health outcomes; practice guidelines do not recommend SNV testing for breast cancer management.

OncoVue®, GeneType®, BREVAGen®, and BREVAGen plus® breast cancer risk tests are considered investigational for all indications, including use to estimate an individual's risk of developing breast cancer. These named assays are not covered when used for breast cancer risk estimation.

Use of SNV risk panels for individual patient care or population breast cancer screening is considered premature. Performance in intended-use populations remains uncertain, the currently known genetic factors do not explain most breast cancer risk, and the available evidence does not demonstrate sufficient discriminatory power for routine clinical use.

Results from SNV panels are not sufficient by themselves to identify women who warrant individualized preventive treatment, such as tamoxifen, MRI screening, or more aggressive intervention.

Use of polygenic risk scores or SNV-based testing for clinical management or breast cancer risk prediction is not supported as standard clinical care. Current guidance recommends use of polygenic risk scores for clinical management only in the context of a clinical trial, and the policy considers SNV-based testing investigational.

SNV-based models used to predict nonfamilial breast cancer risk are not supported as clinically useful because the discrimination offered by currently known genetic factors is insufficient to inform clinical practice.

Use of OncoVue® or BREVAGen Plus® risk estimates in asymptomatic individuals is not supported by sufficient evidence that resulting management changes improve patient outcomes. Available evidence suggests that improvements in risk prediction may be modest, while the effects on management decisions and outcomes remain unclear.

Coding Information

CPT CodesCPT

81479	Unlisted molecular pathology procedure
81599	Unlisted multianalyte assay with algorithmic analysis

Coding Threshold

BI-RADS 3 one-year breast cancer probability2%

Coding Threshold

BI-RADS 4A one-year breast cancer probability6%

Coding Threshold

Biopsy risk threshold used in reclassification analysis2%

Provider Guidance

Denial Risk

Do not order SNV testing for breast cancer risk prediction

Coverage is denied when testing for one or more single-nucleotide variants (SNVs) is performed to predict an individual’s risk of breast cancer because the service is considered investigational. OncoVue, GeneType, BREVAGen, and BREVAGen plus breast cancer risk tests are investigational for all indications.

Denial Risk

Insufficient validation or clinical utility

SNV panels and polygenic risk models used to predict nonfamilial breast cancer risk are at risk of denial because their analytic and clinical validation, discriminatory performance, and ability to improve clinical management or health outcomes have not been sufficiently demonstrated. Use for individual patient care or population screening is considered premature.

Denial Risk

Commercial test benefit is not established

Background

Single-nucleotide variants (SNVs) are common single-base-pair variations that generally confer only small changes in breast cancer risk. Commercial assays combine multiple SNVs, sometimes with clinical risk factors such as family history and breast density, to estimate an individual's risk relative to the general population. The policy notes that independent clinical validity in intended-use populations and evidence that SNV-based risk assessment improves health outcomes have not been established.

Definitions

Analytic validityThe technical accuracy of a test in detecting a variant that is present or excluding a variant that is absent.

Definitions

Clinical validityThe diagnostic performance of a test, including sensitivity, specificity, and positive and negative predictive values, in detecting clinical disease.

Definitions

Clinical utilityHow test results are used to change patient management and whether those management changes produce clinically important improvements in health outcomes.

Definitions

Not Covered Services

Testing for one or more single-nucleotide variants (SNVs) to predict an individual's risk of breast cancer is not covered because it is considered investigational.

OncoVue®, GeneType®, BREVAGen®, and BREVAGen plus® breast cancer risk tests are not covered for all indications, including use to estimate an individual's risk of developing breast cancer.

SNV panels or polygenic risk scores used for individualized breast cancer risk management or population breast cancer screening are not covered because their clinical performance and utility have not been sufficiently established.

OncoVue® and BREVAGen Plus® risk estimates used to guide management in asymptomatic individuals are not covered because evidence is insufficient to show that resulting management changes improve patient outcomes.

SNV panel tests and clinical-SNV genetic tests used to predict breast cancer risk, including but not limited to OncoVue® and BREVAGen plus®, are considered investigational and are not covered because evidence is insufficient to establish that testing guides treatment decisions or improves health outcomes.