Figure 4 is a PRISMA diagram illustrating the review of articles identified via grey literature search for this systematic review. For regulatory information, the U.S. Food and Drug Administration (FDA) website was searched for PMA or 510(k) summaries for commercially FDA approved diagnostic tests for PCA3. No documents were identified. ClinicalTrials.gov was searched. Six studies were identified but all were excluded (4 met exclusion criterion, 1 was an incomplete trial, and 1 was an unpublished trial). The World Health Organization web site was searched and no studies were identified. Conference abstracts and papers from 7 professional societies were searched. These included the College of American Pathologists, the American Urological Association, the American Society of Clinical Oncology, the American College of Medical Genetics, the Association of Molecular Pathology, the NCCN Annual Congress, and PCRI. The search of these sources yielded 272 citations. All of these met exclusion criteria (255 with title and abstract screen and 17 with full text review). Three sources for grants and federally funded projects were searched. The first was NIH RePORTER, which is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions. The second was HSRPROJ, which is a database providing access to ongoing grants and contracts in health services research. The third was AHRQ GOLD, which is an online searchable database of AHRQ grants, working papers and HHS recovery act projects. The search of all 3 databases yielded 26 citations. Twenty were excluded on title and abstract screen, 5 on full text review. Following full text review one article was included in this report. Searches were performed for seven organizations publishing guidance and review documents (ANZHTA, CADTH, Cochrane, EuNetHTA, EuroGENTest, Nat. Guidelines Clearinghouse, NNICE, and UK HTA). Ninety eight documents were identified; all met exclusion criterion during title and abstract screen. Finally a single manufacturer provided a scientific information packet or SIP. This packet included 24 citations: 6 excluded during title and abstract review and 18 excluded following full text review.

Figure 4PRISMA diagram for identified grey literature

ACMG = American College of Medical Genetics; AHRQ = Agency for Healthcare Research and Quality; AMP = Association for Molecular Pathology; ASCO = American Society of Clinical Oncology; AUA = American Urological Association; CADTH = Canadian Agency for Drugs and Technologies in Health; CAP = College of American Pathologists; EuNetHTA = European Network for Health Technology Assessment; FDA = U.S. Food and Drug Administration; HSRPROJ = Health Services Research Projects in Progress; NCCN = National Cancer Consortium Network; NICE = U.K. National Institute for Health and Clinical Excellence; PCRI = Prostate Cancer Research Institute; RePORTER = National Institutes of Health Research Portfolio Online Reporting Tools Expenditures and Results tool; UK HTA = United Kingdom Health Technology Assessment Programme; WHO = World Health Organization

From: Results

Cover of PCA3 Testing for the Diagnosis and Management of Prostate Cancer
PCA3 Testing for the Diagnosis and Management of Prostate Cancer [Internet].
Comparative Effectiveness Reviews, No. 98.
Bradley LA, Palomaki G, Gutman S, et al.

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