title: Biomarkers in prostate cancer: what's new?
abstract: OBJECTIVE
  This review is intended to provide an overview of the current state of biomarkers for prostate cancer (PCa), with a focus on biomarkers approved by the US Food and Drug Administration (FDA) as well as biomarkers available from Clinical Laboratory Improvement Amendment (CLIA)-certified clinical laboratories within the last 1-2 years.
  
  
  RESULTS
  During the past 2 years, two biomarkers have been approved by the US FDA. These include proPSA as part of the Prostate Health Index (phi) by Beckman Coulter, Inc and PCA3 as Progensa by Gen Probe, Inc. With the advances in genomic and proteomic technologies, several new CLIA-based laboratory-developed tests have become available. Examples are Oncotype DX from Genomics Health, Inc, and Prolaris from Myriad Genetics, Inc. In most cases, these new tests are based on a combination of multiple genomic or proteomic biomarkers.
  
  
  CONCLUSIONS
  Several new tests, as discussed in this review, have become available during the last 2 years. Although the intended use of most of these tests is to distinguish PCa from benign prostatic conditions with better sensitivity and specificity than prostate-specific antigen, studies have shown that some of them may also be useful in the differentiation of aggressive from nonaggressive forms of PCa.
authors.affiliation: aDepartment of Pathology (Clinical Chemistry), Johns Hopkins Medical Institutions, Baltimore, Maryland bUS Army Medical Department Center and School, Fort Sam Houston cDepartment of Pathology (Clinical Chemistry), Oncology, Radiology and Urology, Johns Hopkins Medical Institutions, Baltimore, Maryland, Texas, United States.
authors.forename: David A
authors.initials: DA
authors.lastname: Sartori
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Chan
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D052138:Genes, Neoplasm; D005819:Genetic Markers; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000235:genetics; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D005819:Genetic Markers