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Bradley LA, Palomaki G, Gutman S, et al. PCA3 Testing for the Diagnosis and Management of Prostate Cancer [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. (Comparative Effectiveness Reviews, No. 98.)
This publication is provided for historical reference only and the information may be out of date.
Regulatory Information
- FDASource: http://www.fda.gov/default.htmDate searched: 5/15/2012Search strategy: key word “PCA3”Records: 219
Clinical trial registries
- NIH databaseSource: http://clinicaltrials.gov/Date searched: 5/15/2012Search strategy: PCA3 [ALL-FIELDS] AND “Completed” [OVERALL-STATUS]Records: 6
- BioMed centralDate searched: 8/15/2011Search strategy: “PCA3” for completed trialsRecords: 0
- WHO International Clinical Trials Registry Platform Search PortalSource: http://apps.who.int/trialsearch/Date searched: 8/15/2011Search strategy: Search String = “PCA3” for ALL recruitment status trialsRecords: 0
Conference papers and abstracts
- American College of Medical Genetics (ACMG)Date searched: 8/15/2011Search strategy: search string “PCA3 OR Prostate Cancer OR Prostate Cancer Screening”Records: 2
- American Society of Clinical Oncology (ASCO)Date searched: 8/15/2011Search strategy: search string “PCA3”Records: 6
- American Urological Association (AUA)Date searched: 8/15/2011Search strategy: search string “PCA3”Records: 26
- Association of Molecular Pathology (AMP)Date searched: 8/15/2011Search strategy: not searchable without loginRecords: 0
- College of American Pathologists (CAP)Date searched: 8/15/2011Search strategy: search string “PCA3 OR Prostate Cancer OR Prostate Cancer Screening”Records: 240
- National Comprehensive Cancer Network (NCCN) Annual CongressSource: http://www.nccn.org/index.aspDate searched: 8/15/2011Search strategy: search string “PCA3”Records: 0
- Prostate Cancer Research Initiative (PCRI)Date searched: 8/15/2011Search strategy: search string “PCA3”Records: 0
Organizations publishing Guidance or Review Documents
- Agence d'évaluation des technologies et des modes d'intervention en santé (AETMIS)Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 0
- Australia and New Zealand Horizon Scanning Network (ANZHSN)Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 0
- Canadian Agency for Drugs and Technologies in Health (CADTH)Source: http://cadth.ca/Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 3 (all excluded; not relevant)
- The Cochrane Collaboration (Cochrane)Source: http://summaries.cochrane.org/Date searched: 8/15/2011Search strategy: search string string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR“differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 0
- European network for Health Technology Assessment (EUnetHTA)Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 0
- EuroGenTestSource: http://www.eurogentest.org/Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 0
- National Guideline Clearinghouse (NGC)Source: http://www.guideline.gov/Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”). – searches done in different combinations using the above combinations.Records: 4
- National Institute for Clinical Excellence (NICE)Source: http://www.nice.org.uk/Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 1 (excluded; not relevant)
- United Kingdom Health Technology Assessment Programme (UK HTA)Source: http://www.hta.ac.uk/Date searched: 8/15/2011Search strategy: search string (“PCA3” OR “prostate cancer antigen 3” OR “DD3” OR “differential display code 3” OR “biomarkers”) AND (“prostate cancer” OR “prostatic cancer”).Records: 7
Government documents
- RePORTERDate searched: 8/15/2011Search strategy: key word “PCA3”Records: 26
- HSRPROJDate searched: 8/15/2011Search strategy: key word “PCA3”Records: 0
- AHRQ GOLDDate searched: 8/15/2011Search strategy: key word “PCA3”Records: 0
Manufacturer database
- Source: GenProbe Response to the Request for Scientific InformationDate posted: 12/7/2011Date searched: Not applicableSearch strategy: Not applicableRecords: 27
References for Review and Abstraction from the Grey Literature Search
PUBMED ID: NA
Authors: Submitted by Gen-Probe, Inc.
Title: Summary of Safety and Effectiveness Data: PROGENSA PCA3 Assay.
Citation: U.S. Food and Drug Administration, http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100033b.pdf, accessed June 1, 2012.
Selected Test Manufacturers for Contact
Manufacturer | Registered® / Trademark Name™ | Test Type | Comment |
---|---|---|---|
GenProbe | Gen-Probe PROGENSA PCA3 | FDA Approval announced 2/17/12 | Responded pre-FDA approval |
Quest Diagnostics | PCA3 Diagnostic Test | LDT | Did not respond |
Bostwick Laboratories | PCA3Plus® | LDT | Did not respond |
Laboratory Corporation of America | CaPDetect: PCA3 | LDT | Did not respond |
Contact Information
Gen Probe Incorporated | 10210 Genetic Center Drive San Deigo, CA 92121 Phone: 858-410-8000 http://www |
Quest Diagnostics | 3 Giralda Farms Madison, NJ 07940 Phone: 800-222-0446 http://www |
Bostwick Laboratories | 4355 Innslake Drive Glen Allen, VA 23060 Phone: 877-865-3262 http://www |
Laboratory Corporation of America | 358 South Main Street Burlington, NC 27215 Phone: 336-584-5171 http://www |
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