Commercialized biomarkers: new horizons in prostate cancer diagnostics

Abstract

Limitations with current clinical tools available for diagnosis and prognosis of prostate cancer (PCa) have resulted in overdiagnosis and costly overtreatment, which is affecting the outcomes and quality of life of men. The biotech industry is investing significant resources into developing more specific biomarkers for PCa detection and patient stratification that would greatly advance the decision-making processes behind PCa management and treatment. In this review, we focus on those biomarkers that have been translated into commercial tests available to clinicians. Since these tests aim to fill specific gaps during the decision-making process of PCa management, we have grouped them based on the clinical question they claim to address, that is, improved PCa screening, false-negative biopsy dilemma, prognostic tests following a positive biopsy and tests predicting relapse/metastases after surgery. We evaluate each test with respect to its development, platform, clinical validation, biomatrix, regulatory approval status and cost.

Keywords:

• clinical utility
• commercialized prostate cancer tests
• false-negative biopsy dilemma
• patented biomarkers
• prostate cancer screening

Acknowledgements

Funding is acknowledged from the Health Research Board Science Foundation Ireland Translational Research Award Grant # TRA/2010/18, Marie Curie (FP-7) Industry-Academia Partnerships and Pathways under the ‘FAST-PATH’ program, the Irish Cancer Society under grant # CRF12PRE and the Prostate Cancer Research Consortium.

Financial & competing interests disclosure

M Prencipe has been on secondment from University College Dublin to OncoMark from 1st September 2013 to 31st August 2014, where her official status is that of an employee; she does not hold any stock in this company. WM Gallagher is Chief Scientific Officer at OncoMark, holds stock and is a director of the company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Limitations with the gold standard clinical tools available for the diagnosis and prognosis of prostate cancer (PCa) result in both overdiagnosis and costly overtreatment.

• In the past few years, new diagnostic/prognostic biomarkers have been translated into commercial diagnostic tests for PCa.

• Each new test should be tailored to address a specific clinical question for which limited diagnostic options are currently available.

• Tests aimed at improving PCa screening include 4Kscore Prostate Cancer Test, Prostarix and Prostate Health Index (phi).

• Cancer can be missed in up to 25% of men who receive a negative biopsy result. Tests addressing this dilemma include Progensa PCA3, ConfirmMDx and the Prostate Core Mitomic Test.

• Tests that can predict and monitor PCa grade, stage and aggressiveness with better accuracy and less morbidity include Prolaris, Oncotype DX Prostate Cancer Assay and Our View Prognostic Panel.

• Current clinical tools cannot accurately determine a patient’s true risk of metastasis or monitor patients with metastatic cancer throughout their treatment. Tests addressing these dilemmas include Decipher, NADiA ProsVue and the CellSearch CTC kit.

• Based on the clinical question, a test should be both specific and sensitive to avoid undertreatment and overdiagnosis.

• Tests achieving the most convincing clinical validation will be incorporated into routine clinical practice providing new diagnostic tools to clinicians, ultimately making PCa diagnosis and prognosis more accurate and reliable.

Notes