Test ID: FPCA3
PCA3 Assay
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Method Name A short description of the method used to perform the test
Target capture, transcription-mediated amplification (TMA)
Hybrid protection assay (HPA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
PCA3 FORWARD
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Urine
Collect specimen using PROGENSA Urine Specimen Transport Tube (supply T695) as follows:
1. Patient should undergo a thorough digital rectal exam (DRE) (3 strokes per lobe). Collect the first 20-30 mL urine of the patient’s next void immediately following the DRE. If more than 30 mL collected, do not discard, mix thoroughly.
2. Mix to re-suspend cells, pipette 2.5 mL of urine to PROGENSA tube. The maximum time between collection and transfer to the PROGENSA tube is 20 minutes. The correct volume of urine has been added when the fluid level is between the black fill lines on the PROGENSA urine transport tube. Invert tube 5 times to mix the urine and the transport medium.
3. Send PROGENSA transport tube ambient.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis: | Urine |
| Thawing: | Warm OK; Cold OK |
| Lipemia: | NA |
| Icterus: | NA |
| Other: | Volume <2 mL; incorrect collection kit; Aptima media |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Urine | Ambient (preferred) | 5 days |
| Frozen | 5 days | |
| Refrigerated | 5 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Background: PCA3 is a non-coding prostate-specific mRNA that is highly over-expressed in some prostate cancer cells (median 66-fold over adjacent benign tissue); in contrast. PSA gene expression is similar in benign and malignant prostate cells. Both PCA3 and PSA mRNA can be quantitated from urine samples. The PCA3 assay utilizes voided urine collected following a digital rectal examination and processed by addition into a urine transport medium (UTM) which lyses cells and stabilizes RNA. The PSA mRNA level serves to confirm that there is sufficient prostate RNA for analysis present in the sample and to normalize the PCA3 mRNA signal. In a study of 466 patients with previous negative prostate biopsy, 102 of whom had a positive follow-up biopsy, utilizing the PCA3 score cutoff value of 25 was shown to have 77.5% sensitivity and 57.1% specificity for prostate cancer. This assay is indicated for use in conjunction with other patient information to aid in the decision of repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care, before consideration of the PCA3 assay results. This assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy; men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.
| PCA3 score interval | Number of subjects | Percent of subjects with Positive Biopsy |
| <12 | 114 | 10% |
| 12-<25 | 117 | 12% |
| 25-<47 | 116 | 28% |
| 47+ | 119 | 35% |
This figure shows the percentage of subjects with positive biopsy results by PCA3 score interval.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Reference Range:
<25 negative
> or = 25 positive
Comment: Due to normal assay variability, specimens with PCA3 scores near the cut-off of 25 (i.e. 18-31) could yield a different overall interpretation of positive or negative upon repeat testing. PCA3 scores in the range from 18 to 31 should, therefore, be interpreted with caution.
The testing method is target capture, transcription-mediated amplification (TMA) and hybrid protection assay (HPA), manufactured by Gen-Probe and performed using the Gen-Probe PROGENSA assay kit.
Test Performed by: DIANON Systems, Inc.
1 Forest Parkway
Shelton, CT 06484
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Aubin SM et al. 2010. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasterid REDUCE trial. Urology. 184:1947-1952.
Mark LS et al. 2007. PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy. Urology. 44:8-16.
PROGENSA PCA3 Assay Package Insert 502083 Rev. A. Gen-Probe Incorporated.
Method Description Describes how the test is performed and provides a method-specific reference
The PCA3 assay is performed utilizing the PROGENSA assay kit from Gen-Probe, comprised of two quantitative nucleic acid amplification tests, one for PCA3 RNA, one for PSA RNA. In both, the target RNA molecules are isolated from urine specimens utilizing complementary RNA oligonucleotides and a magnetic separation system to capture the target sequences. A reverse transcriptase is utilized to make DNA copies (template) of the target RNA, and an RNA polymerase is utilized to produce multiple RNA copies (amplicon) of the template (transcription-mediated amplification or TMA). Chemiluminescence-labeled complementary probes are utilized to detect the amounts of amplicon present. PCA3 and PSA mRNA are quantiated by comparison with standard curves generated with every assay. The PCA3 score is calculated as 1000 times the ratio of the concentration of PCA3 RNA to the concentration of PSA RNA ([PCA3 mRNA]/[PSA mRNA] x 1000).
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Varies, Monday through Saturday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Performing Laboratory Location The location of the laboratory that performs the test
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
81479
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| Z2997 | Specimen type | In Process |
| Z2998 | Result (PCA3 Score) | In Process |
| Z2999 | Interpretation | In Process |
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