Palmetto GBA’s MolDX Issues Foundational LCD Covering the Indication for SelectMDx for Prostate Cancer - mdxhealth (2024)

· Albala D, Kemeter MJ, Febbo PG, Lu R, John V, Stoy D et al. Health economic impact and prospective clinical utility of Oncotype DX Genomic Prostate Score. Rev Urol. 2016; 18(3):123-132.

· Dall’Era MA, Maddala T, Polychronopoulos L, Gallagher JR, Febbo PG, and Denes BS. Utility of the Oncotype DX® Prostate Cancer Assay in Clinical Practice for Treatment Selection in Men Newly Diagnosed with Prostate Cancer: A Retrospective Chart Review Analysis. Urology Practice. 2015;2(6):343-348.

· Eure G, Germany R, Given R, Lu R, Shnidel AW, Rothney M, et al. Use of a 17-Gene Prognostic Assay in Contemporary Urologic Practice: Results of an Interim Analysis in an Observational Cohort. Urology. 2017;107:67-75.

· Lynch JA, Rothney MP, Salup RR, Ercole CE, Mathur SC, duch*ene DA, et al. Improving Risk Stratification Among Veterans Diagnosed With Prostate Cancer: Impact of the 17-Gene Genomic Prostate Score Assay. Am J Manag Care. 2017;24(1 Suppl):S4-S10.

· Murphy AB, Abern MR, Liu L, Wang H, Hollowell CMP, Sharifi R, Vidal P, et al. Impact of a Genomic Test on Treatment Decision in a Predominantly African American Population With Favorable-Risk Prostate Cancer: A Randomized Trial. J Clin Oncol. 2021;39(15):1660-1670.

· Brooks MA, Thomas L, Magi-Galluzzi C, Li J, Crager MR, Lu R et al. GPS assay association with long-term cancer outcomes: twenty-year risk of distant metastasis and prostate cancer-specific mortality. JCO Precis Oncol. 2021;5:PO.20.00325.

· Brooks MA, Thomas L, Magi-Galluzzi C, Li J, Crager MR, Lu R et al. Validating the association of adverse pathology with distant metastasis and prostate cancer mortality 20-years after radical prostatectomy. Urol Oncol. 2022;40(3):104.e1-104.e7.

· Covas Moschovas M, Chew C, Bhat S, Sandri M, Rogers T, Dell’Oglio P, et al. Association Between Oncotype DX Genomic Prostate Score and Adverse Tumor Pathology After Radical Prostatectomy. Eur Urol Focus. 2022;8(2):418-424.

· Cullen J, Rosner IL, Brand TC, Zhang N, Tsiatis AC, Moncur J, et al. A biopsy-based 17-gene genomic prostate score predicts recurrence after radical prostatectomy and adverse surgical pathology in a racially diverse population of men with clinically low- and intermediate-risk prostate cancer. Eur Urol. 2015;69(1):123-131.

· Cullen J, Kuo HC, Shan J, Aboushwareb T, and Van Den Eeden SK. The 17-gene genomic prostate score test as a predictor of outcomes in men with unfavorable intermediate-risk prostate cancer. Urology. 2020;143:103-111.

· Cullen J, Lynch JA, Klein EA, Van Den Eeden SK, Carroll PR, Mohler JL, et al. Multicenter Comparison of 17-Gene Genomic Prostate Score as a Predictor of Outcomes in African American and Caucasian American Men with Clinically Localized Prostate Cancer. J Urol. 2021;205(4):1047-1054.

· Eggener S, Karsh LI, Richardson T, Shindel AW, Lu R, Rosenberg A et al. A 17-gene panel for prediction of adverse prostate cancer pathologic features: prospective clinical validation and utility. Urology. 2019;126:76-82.

· Helfand BT, Paterakos M, Wang CH, Talaty P, Abran J, Bennett J et al. The 17-gene Genomic Prostate Score assay as a predictor of biochemical recurrence in men with intermediate and high-risk prostate cancer. PLoS One. 2022;17(9):e0273782.

· Helfand BT, Paterakos M, Wang CH, Talaty P, Abran J, Bennett J et al. The 17-gene Genomic Prostate Score assay as a predictor of biochemical recurrence in men with intermediate and high-risk prostate cancer. PLoS One. 2022;17(9):e0273782.

· Janes JL, Boyer MJ, Bennett JP, Thomas VM, De Hoedt AM, Edwards DK, et al. Prognostic for outcomes after primary external beam radiation therapy in men with clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2023;115(1):120-131.

· Klein EA, Cooperberg MR, Magi-Galluzzi C, Simko JP, Falzarano SM, Maddala T et al. A 17-gene assay to predict prostate cancer aggressiveness in the context of Gleason grade heterogeneity, tumor multifocality, and biopsy undersampling. Eur Urol. 2014;66(3):550–560.

· Kornberg Z, Cowan JE, Westphalen AC, Cooperberg MR, Chan JM, Zhao S, et al. Genomic prostate score, PI-RADS version 2 and progression in men with prostate cancer on active surveillance. J Urol. 2019;201:300-307.

· Leapman MS, Westphalen AC, Ameli N, Lawrence HJ, Febbo PG, Cooperberg M, et al. Association between a 17-gene genomic prostate score and multi-parametric prostate MRI in men with low and intermediate-risk prostate cancer. PLoS One. 2017;12(10):e0185535.

· Lin D, Zheng Y, McKenney JK, Brown MD, Lu R, Crager M, et al. 17-gene genomic prostate score test results in the Canary Prostate Active Surveillance Study (PASS) cohort. J Clin Oncol. 2020;38(14):1549-1557.

· Magi-Galluzzi C, Isharwal S, Falzarano SM, Tsiatis A, Dee A, Maddala T et al. The 17-gene genomic prostate score assay predicts outcomes after radical prostatectomy independent of PTEN status. Urology. 2018;121:132-138.

· Murphy AB, Carbunaru S, Nettey OS, Gornbein C, Dixon MA, Macias V, et al. A 17-Gene Panel Genomic Prostate Score Has Similar Predictive Accuracy for Adverse Pathology at Radical Prostatectomy in African American and European American Men. Urology. 2020; 142:166-173.

· Salmasi A, Said J, Shindel AW, Khoshnoodi P, Felker ER, Sisk Jr AE et al. A 17-gene Genomic Prostate Score assay provides independent information on adverse pathology in the setting of combined multiparametric magnetic resonance fusion-targeted and systematic prostate biopsy. J Urol. 2018;200(3):564-572.

· Van Den Eeden SK, Lu R, Zhang N, Queensberry Jr CP, Shan J, Han JS, et al. A biopsy-based 17-gene genomic prostate score as a predictor of metastases and prostate cancer death in surgically treated men with clinically localized disease. Eur Urol. 2017;73(1):129-138.

Palmetto GBA’s MolDX Issues Foundational LCD Covering the Indication for SelectMDx for Prostate Cancer - mdxhealth (2024)

FAQs

What is the SelectMDx test for prostate cancer? ›

SelectMDx is a decision support tool specific to prostate cancer. Unlike other prostate cancer tests, SelectMDx provides a risk score not only for prostate cancer in general, but also for the likelihood of aggressive prostate cancer. Those at risk for aggressive disease benefit most from early intervention and biopsy.

What is the best diagnostic tool for prostate cancer? ›

A core needle biopsy is the main method used to diagnose prostate cancer. It is usually done by a urologist. During the biopsy, the doctor usually looks at the prostate with an imaging test, such as transrectal ultrasound (TRUS) or MRI, or a 'fusion' of the two (all discussed below).

Can saw palmetto be used for prostate cancer? ›

What is it? Saw palmetto was shown in some studies to help relieve the symptoms of benign prostatic hypertrophy (BPH), but it has not been shown to prevent or treat prostate cancer. Studies in the laboratory show that saw palmetto works by countering effects of male sex hormones such as testosterone and DHT.

What are the new biomarkers for prostate cancer? ›

The new MPS2 urine test, developed by researchers at the University of Michigan, screens for 18 genetic markers that are highly associated with clinically significant prostate cancers – cancers that can grow quickly and should be monitored or treated – classified as grade group (GG) 2 and higher.

How accurate is the SelectMDx test? ›

The sensitivity of SelectMDx for the detection of clinically significant PCa ranged from 37% to 100%, whereas the specificity ranged from 12% to 100%.

What is the most reliable test for prostate cancer? ›

If your doctor determines you should undergo screening, he or she will most likely recommend the PSA test. For more than 30 years, the PSA test has been the gold standard in prostate cancer screening. This simple blood test measures how much prostate-specific antigen is in your blood.

What is the new test for prostate cancer 2024? ›

ASCO 2024: Prostate cancer spit test better for men with high genetic risk than standard blood test - The Institute of Cancer Research, London.

At what PSA level should a biopsy be done? ›

Many doctors recommend a prostate biopsy for men whose percent-free PSA is 10% or less, and advise that men consider a biopsy if it is between 10% and 25%. Using these cutoffs detects most cancers and helps some men avoid unnecessary biopsies.

What is an alarming PSA level? ›

If you have a PSA level greater than 10, you have over a 50% chance of having prostate cancer. It's very important to talk to a healthcare provider about a prostate biopsy if your PSA is in these ranges.

What supplements should I avoid with prostate cancer? ›

Selenium may play a role in many diseases, including cancer. Results of the large National Cancer Institute-sponsored Selenium and Vitamin E Cancer Prevention Trial (SELECT) suggest that men with prostate cancer should not take selenium supplements.

What medications should not be taken with saw palmetto? ›

Antiplatelet and anticoagulant drugs (blood-thinners)

Saw palmetto may affect the blood's ability to clot, and could interfere with blood-thinning drugs, including: Warfarin (Coumadin) Clopidogrel (Plavix) Aspirin.

Who shouldn't take saw palmetto? ›

Pregnancy and breast-feeding: Saw palmetto is likely unsafe when taken by mouth during pregnancy or breast-feeding. It acts like a hormone, and this could be dangerous. Don't use during pregnancy or breast-feeding. Surgery: Saw palmetto might slow blood clotting.

What is the new wonder drug for prostate cancer? ›

Enzalutamide works by disrupting testosterone's interaction with cancer cells. It's already approved by FDA to treat nonmetastatic and metastatic prostate cancer, including when the cancer can no longer be controlled with drugs that block testosterone production (like leuprolide), known as castration-resistant disease.

What is the new breakthrough for prostate cancer? ›

Scientists have developed targeted therapies based on PSMA, the same protein that is used for imaging prostate cancer. For treatment, the molecule that targets PSMA is chemically linked to a radioactive substance. This new compound can potentially find, bind to, and kill prostate cancer cells throughout the body.

What is the newest and best treatment for prostate cancer? ›

Exablate Prostate, developed by the health care technology company Insightec, uses high-intensity sound waves, or ultrasound, to target and destroy cancer cells within the prostate while leaving surrounding healthy tissues unaffected.

What is a ConfirmMDX test? ›

The ConfirmMDX test is performed on tissue samples taken during a prior biopsy. The test examines the sample's DNA to look for markers that indicate more aggressive cancer.

What is the main screening test for prostate cancer? ›

Prostate-specific antigen test

A prostate-specific antigen (PSA) test is a test that measures the level of PSA in the blood. PSA is a substance made mostly by the prostate that may be found in an increased amount in the blood of men who have prostate cancer.

When to use selectmdx? ›

If you learn that your PSA level is abnormal and/or that you have other clinical risk factors (age, increased prostate volume, family history of prostate cancer, abnormal DRE result) for prostate cancer, talk to your urologist about ordering the Select mdx test—before having a prostate biopsy.

What is the current test for prostate cancer? ›

The PSA test is a blood test to help detect prostate cancer. But it's not perfect and will not find all prostate cancers. The test, which can be done at a GP surgery, measures the level of prostate-specific antigen (PSA) in your blood. PSA is a protein made only by the prostate gland.

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