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NCCN Updates Prostate Cancer Early Detection Guidelines With Biomarker Information

NEW YORK (GenomeWeb) – The National Comprehensive Cancer Network has updated its guidelines on early detection of prostate cancer to include more specific language about how often men with BRCA mutations should be screened and the potential utility of certain biomarkers for determining high-grade cancer risk.

The NCCN's "Prostate Cancer Early Detection" guidelines previously noted that men over 65 years old with prostate cancer who are BRCA1/2 mutation carriers have a greater likelihood of prostate cancer mortality, and that information about germline mutations should be part of discussions about prostate cancer screening.

The updated guidelines now specify that "it is reasonable for men with germline BRCA1/2 mutations to consider beginning shared decision making about PSA screening at age 40 and to consider screening at annual intervals rather than every other year."

The updated guidelines also note that certain biomarker tests may be "potentially informative" when trying to further define the probability of high-grade cancer.

"Biomarkers that improve the specificity of detection are not, as yet, mandated as first-line screening tests in conjunction with serum PSA," the NCCN wrote. "However, there may be some patients who meet PSA standards for consideration of prostate biopsy, but for whom the patient and/or the physician wish to further define the probability of high-grade cancer."

For patients who have never had a biopsy or have had a negative biopsy, the NCCN wrote that that a percent free PSA of less than 10 percent, a Prostate Health Index of greater than 35, an EPI score greater than 15.6, or a 4Kscore are "potentially informative" as to the probability that they'll progress to high-grade prostate cancer.

The mention of the EPI score in the guidelines — which refers to Bio-Techne/Exosome Dx's ExoDx Prostate test —  among biomarkers that may improve the specificity of defining high-grade cancer, is new. The exosome expression assay analyzes PCA3, ERG, and RNA from a urine sample. According to a statement from Bio-Techne, the tests, launched at the end of 2017, have been ordered by more than 1,100 practicing urologists in the US and studied in more than 5,000 patients.  

Meanwhile, Opko Health received a notice of non-coverage for its 4Kscore prostate cancer test from Medicare contractor Novitas.