NEW YORK (GenomeWeb) – The National Comprehensive Cancer Network has included two molecular diagnostics – Myriad Genetics' Prolaris and Genomic Health's Oncotype DX Prostate Cancer – in its most recent guidelines for the disease, noting that these two assays "appear further along in development and clinical use" than other options on the market.
"American men continue to underselect active surveillance for very low- or low-risk prostate cancer largely due to uncertainty about the risk of disease progression, an uncertainty that could be reduced by a molecular biomarker that can be measured accurately and reproducibly and provide prognostic or predictive information beyond NCCN risk group assignment and currently available tables and nomograms," the NCCN stated in the "molecular testing" section of the guidelines.
According to NCCN, the available evidence on Prolaris backs its use as a tool that doctors can use to gauge whether patients are at risk of biochemical recurrence or metastasis after radical prostatectomy; to assess survival for men being observed after cancer diagnosis, transurethral resection of the prostate or diagnostic needle biopsy; and to track patients for biochemical recurrence and survival after they've received external beam radiation therapy.
Myriad issued a statement highlighting that the latest NCCN guidelines supported the use of Prolaris "for all men with localized prostate cancer, regardless of their risk category." In terms of reimbursement, however, Myriad recently received a draft local coverage determination (LCD) from Medicare contractor Palmetto GBA which proposes to reimburse Prolaris for patients at low risk of disease progression who are expected to live for a decade or longer.
Meanwhile, Genomic Health's Oncotype DX Prostate Cancer test, according to NCCN, may provide prognostic information beyond standard clinical data for patients who may have Gleason score 7 or disease that extends beyond the prostatic capsule on radical prostatectomy.
"Prolaris has changed treatment recommendations in 32 percent to 65 percent of cases and may enhance adherence to the treatment recommended," the guidelines group stated. "Oncotype DX GPS improved upon NCCN risk group assignment, which may enhance rates of compliance with recommended active surveillance or diminish the number of surveillance prostate biopsies."
Although NCCN continued to express preference for evidence from prospective, randomized studies to prove these tests' ability to impact patient outcomes, the group acknowledged that in prostate cancer such studies are unlikely to be performed in the context of prognostic molecular diagnostic tools. "The marketplace and comparative effectiveness research may be the only means for these tests and others like them to gain their proper place for better risk stratification for men with clinically localized prostate cancer," the NCCN said.