Medical policy: Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer

Policy number: MP 2.280

Effective date: 4/1/2026

Policy

Genetic and protein biomarkers for the diagnosis of prostate cancer, including, but not limited to the following, are considered investigational:

• Kallikrein markers (e.g., 4KscoreTest)
• Prostate Health Index (PHI)
• HOXC6 and DLX1 testing (e.g., SelectMDx)
• PCA3, ERG, and SPDEF RNA expression in exosomes (e.g., ExoDx Prostate IntelliScore)
• Autoantibodies ARF6, NKX3-1, 5-UTR-BMI1, CEP 164, 3-UTR-Ropporin, Desmocollin, AURKAIP-1, and CSNK2A (e.g., Apifiny)
• PCA3 testing (e.g., Progensa PCA3 Assay)
• TMPRSS:ERG fusion genes (e.g., MyProstate Score)
• Gene hypermethylation testing (e.g., ConfirmMDx)
• Mitochondrial DNA mutation testing (e.g., Prostate Core Mitomics Test)
• PanGIA Prostate
• Candidate gene panels

Single nucleotide variant testing for cancer risk assessment of prostate cancer is considered investigational. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with the above procedures.

Cross-references

• MP 2.259 Molecular Panel Testing of Cancers to Identify Targeted Therapies
• MP 2.263 Gene Expression Profiling, Protein Biomarkers, and Multimodal Artificial Intelligence for Prostate Cancer Management
• MP 2.261 Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy)
• MP 2.277 Investigational Miscellaneous Genetic and Molecular Tests

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/background

Prostate cancer

Prostate cancer is the most common cancer, and the second most common cause of cancer death in men. Prostate cancer is a complex, heterogeneous disease, ranging from microscopic tumors unlikely to be life-threatening to aggressive tumors that can metastasize, leading to morbidity or death. Early localized disease can usually be treated with surgery and radiotherapy, although active surveillance may be adopted in men whose cancer is unlikely to cause major health problems during their lifespan or for whom the treatment might be dangerous.

In patients with incurable or metastatic disease, treatment consists of hormonal therapy and possibly chemotherapy. The lifetime risk of being diagnosed with prostate cancer in men in the U.S. is approximately 16%, while the risk of dying of prostate cancer is 3%. African American men have the highest prostate cancer risk in the U.S.; the incidence of prostate cancer is about 60% higher and the mortality rate is more than 2 to 3 times greater than that of White men.

Autopsy results have suggested that about 30% of men over the age of 55 and 60% of men over the age of 80 who die of other causes have incidental prostate cancer, indicating that many cases of prostate cancer are unlikely to pose a threat during a man’s life expectancy.

Grading

The most widely used grading scheme for prostate cancer is the Gleason system. It is an architectural grading system ranging from 1 (well-differentiated) to 5 (undifferentiated); the score is the sum of the primary and secondary patterns.

A Gleason score of 6 or less is low-grade prostate cancer that usually grows slowly; 7 is an intermediate grade; 8 to 10 is high-grade prostate cancer that grows more quickly. A revised prostate cancer grading system has been adopted by the National Cancer Institute and the World Health Organization. A cross-walk of these grading systems is shown in Table 1.

Table 1. Prostate cancer grading systems

Rationale

Summary of evidence

For individuals who are being considered for an initial prostate biopsy who receive testing for genetic and protein biomarkers of prostate cancer (e.g., kallikrein biomarkers and 4Kscore Test, proPSA and Prostate Health Index, TMPRSS fusion genes and MyProstate Score, SelectMDx Prostate Cancer, ExoDx Prostate IntelliScore, Apifiny, PCA3 score, and PanGIA Prostate), the evidence includes systematic reviews, meta-analyses, and primarily observational studies.

Relevant outcomes are overall survival, disease-specific survival, test validity, resource utilization, and quality of life. The evidence supporting clinical utility varies by test but has not been directly shown for any biomarker test. Absent direct evidence of clinical utility, a chain of evidence might be constructed. However, the performance of biomarker testing for directing biopsy referrals is uncertain.

While some studies have shown a reduction or delay in biopsy based on testing, a chain of evidence for clinical utility cannot be constructed due to limitations in clinical validity. Test validation populations have included men with a positive digital rectal exam (DRE), a prostate-specific antigen (PSA) level outside of the gray zone (between 3 or 4 ng/mL and 10 ng/mL), or older men for whom the information from test results are less likely to be informative.

Many biomarker tests do not have standardized cutoffs to recommend a biopsy. In addition, comparative studies of the many biomarkers are lacking. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are being considered for repeat biopsy who receive testing for genetic and protein biomarkers of prostate cancer (e.g., PCA3 score, Gene hypermethylation and ConfirmMDx test, Prostate Core Mitomics Test, MyProstate Score), the evidence includes systematic reviews and meta-analyses and primarily observational studies.

Relevant outcomes are overall survival, disease-specific survival, test validity, resource utilization, and quality of life. The performance of biomarker testing for guiding rebiopsy decision making is lacking. The tests are associated with a diagnosis of prostate cancer and aggressive prostate cancer, but studies on clinical validity are limited and do not compare performance characteristics with standard risk prediction models.

Direct evidence supporting clinical utility has not been shown. No data is currently available on the longer-term clinical outcomes of the use of genetic and protein biomarkers to decide on repeat prostate biopsy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational for the diagnosis and cancer risk assessment of prostate cancer; therefore, not covered

References

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