Prostate Cancer Gene 3 (PCA3)

CPT: 81313
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Test Details




Prostate cancer gene 3 (PCA3) is strongly expressed in 95% of primary prostate cancer specimens. The PCA3 test is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men age 50 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. The PCA3 result provides a risk assessment of a positive biopsy.

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.


The ProgensaA® PCA3 assay has the following performance characteristics using the PCA3 score cutoff value of 25 for this patient population: 77.5% sensitivity, 57.1% specificity, 90% negative predictive value and 33.6% positive predictive value.


Target capture, transcription-mediated amplification (TMA) and hybrid protection assay (HPA)

Specimen Requirements




3 mL (Urine specimen fluid level must be between the black lines on the urine transport tube.)

Minimum Volume

2.5 mL


Gen-Probe® Progensa® Urine Specimen Transport Kit (LabCorp PeopleSoft N° 97836, PK=10)


Before collection, the patient should undergo an attentive digital rectal exam (three strokes per lobe).

1. Collect a first-catch (approximately 20 to 30 mL of the initial stream) urine sample in a urine collection cup after DRE has been performed. Urine sample should be processed immediately following steps 2 and 3.

2. Invert the sample five times to resuspend the cells. Transfer 2.5 mL of urine (fill until the fluid level is between the black lines) into the urine specimen transport tube using the disposable pipette provided.

3. Recap the urine specimen transport tube tightly and invert five times to mix.

Storage Instructions

Processed urine specimens must be shipped at 30°C or below (may be frozen) and should be received by the test facility within five days of collection.

Stability Requirements




14 days


3 months

Causes for Rejection

Specimen volume <2.5 mL; incorrect collection kit; specimen received after five days

Clinical Information

Special Instructions

Please direct any questions regarding this test to customer service at 800-345-4363.


Aubin SM, Reid J, Sarno MJ, et al. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol. 2010 Nov; 184(5):1947-1952. 20850153
Marks LS, Fradet Y, Deras IL, et al. PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy. Urology. 2007 Mar; 69(3): 532-535. 17382159
Progensa® PCA3 Assay [package insert]. 502083 Rev A. San Diego, Calif: Gen-Probe Inc; 2012.


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
489160 Prostate Cancer Gene 3 (PCA3) 489162 Results: 69362-2
489160 Prostate Cancer Gene 3 (PCA3) 489165 PCA3 Score: 69361-4
489160 Prostate Cancer Gene 3 (PCA3) 489164 Director Review: N/A

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