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Genomic Biomarker Tests Endorsed for Early Prostate Cancer Management

by | Jun 15, 2022 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Top of the News-dtet

Revised guidelines from the American Urological Association support limited use of the tests for certain prostate cancer patients.

Newly revised guidelines from the American Urological Association (AUA) endorse limited use of tissue-based genomic biomarker tests for patients with localized early-stage prostate cancer. Although limitations apply, the expanded coverage recommendations bode well for Exact Sciences, Myriad Genetics, Bio-Techne, and other firms that manufacture genomic tests for early prostate cancer detection.

The AUA’s 4 Recommendations

The AUA guidelines include four key recommendations for use of laboratory tests to stratify patient risk of prostate cancer, calling on clinicians to:

  1. Use clinical T stage, serum PSA, Grade Group (Gleason score), and tumor volume from biopsy to risk stratify patients with newly diagnosed prostate cancer (Strong Recommendation; Evidence Level: Grade A);
  2. Selectively use tissue-based genomic biomarkers when added risk stratification may alter clinical decision-making (Expert Opinion);
  3. Not routinely use tissue-based genomic biomarkers for risk stratification or clinical decision-making (Moderate Recommendation; Evidence Level: Grade B); and
  4. Perform an assessment of patient and tumor risk factors to guide the decision to offer germline testing that includes mutations with known associations to aggressive prostate cancer and/or known implications for treatment (Expert Opinion).   

According to the AUA, tests that are currently on the market, including Oncotype Dx (Exact Sciences), Prolaris (Myriad Genetics), and Decipher (Veracyte), can predict adverse pathology as well as risks of biochemical recurrence, metastasis, and prostate cancer death. The cloud in the silver lining: The validation evidence for most of these tests were not up to the AUA’s standard for review due to their use of surgical, rather than biopsy specimens. And even the studies that did use biopsy specimens did not meet the AUA bar, the guidelines added.

“Two studies using biopsy data have shown that a cell cycle progression panel (Prolaris) score was associated with the risks of biochemical recurrence, metastatic disease, and prostate cancer death,” according to the AUA; but only one of those studies met inclusion criteria. Studies of Oncotype Dx using needle biopsy tissue also failed to reach a high enough bar.

Despite the qualifications, test makers welcomed the new guidelines as a positive development. Despite the cautious take, test-makers greeted the new recommendations as positive.

"We're pleased that the updated guidelines recognize the impact genomic assays can have on treatment decision-making for men with localized prostate cancer,” noted Exact Sciences’ medical director of urologic oncology Daniel Shoskes, in a statement.

Medicare Contractor OKs Coverage of Genomic Tests for Prostate Cancer Risk Stratification

On a related note, a newly finalized local coverage determination (LCD) from Medicare Administrative Contractor Palmetto GBA provides for reimbursement of molecular biomarker tests for stratifying risks of patients being screened for prostate cancer. Palmetto concluded that there is “adequate evidence” to show that the information provided by validated molecular biomarker tests for prostate cancer changes physician management in a way that improves outcomes. The LCD establishes criteria for coverage of such tests for two applications:

  • Non- or minimally invasive tests to guide the decision of whether to perform an initial biopsy; and
  • Genomic prostate cancer tests provided to further refine patient’s risks after a biopsy in which the results were inconclusive and did not enable pathologists to make a definitive determination about whether cancer is present.

Coverage is not brand-specific. Any test can qualify for coverage as long as it meets the LCD’s coverage criteria and passes a technology assessment performed under Palmetto’s MolDX program. Technical requirements apply. Among other things, tests using an algorithm must be validated in a cohort that is independent from their development cohort. Assays must also demonstrate both clinical validity and clinical utility in peer-reviewed published literature.

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