Integrating Molecular Testing Into Urology Practices


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A variety of molecular tests are available for determining risk, diagnosis, and prognosis for patients with prostate cancer. These tests add onto traditional clinical parameters, such as Gleason score and PSA.

In his practice, Kenneth Kernen, MD, conducts reflex testing with ConfirmMDx in patients with suspicious PSA or biopsy. This test can help guide a rebiopsy decisions. Additionally, other tests may be ordered on an individual basis, including Oncotype DX.

Christopher Pieczonka, MD, explains that larger practices allow for a collective thought process to develop standardization of testing. He acknowledges that testing is currently dependent on what insurance companies will cover. Payers are more likely to cover testing that is incorporated into the NCCN)Guidelines.

In general, insurance coverage for testing procedures occurs after stepwise validation program: assay validation, clinical validation, and finally clinical utility, explains Neal D. Shore, MD. The key issue with clinical validation concerns whether the test will impact management decisions. Since these tests have become available, active surveillance rates have increased, which Kernen states as the goal.

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