PCA3 Prostate Cancer Biomarker
Label Mnemonic: PCA3
Epic Lab Code: LAB7664
Downtime Form: A-1a Miscellaneous Request
Commercial Mail-out Laboratory
5231 RCP
356-8593
Specimen(s):
Urine
Specimen Instructions:
Suggested collection follows a Digital Rectal Exam (DRE). Deliver immediately to Specimen Control for processing of urine.

Invert urine container FIVE times to mix, then transfer 2.5 mL urine to Progensa PCA3 Urine Specimen Transport Tube. Liquid level must be between black lines on transport tube. Cap transport tube and invert FIVE times to mix. This function is performed by Specimen Control staff.
Collection Medium:
Progensa PCA3 Urine Specimen Transport Tube
Minimum:
20-30 mL first catch urine following Digital Rectal Exam (DRE) in preservative-free urine collection cup.
Rejection Criteria:
Urine in original collection cup. Specimens in APTIMA Combo 2 Urine Specimen transport media.
Delivery Instructions:
Deliver to laboratory immediately after collection.
Turn Around Time:
3-6 days upon receipt at reference laboratory.
Reference Range:
PCA3 Ratio Interpretation 0-17 Negative - Result associated with decreased likelihood of a positive biopsy for prostate cancer. 18-24 Negative - Result should be interpreted with caution. Due to normal test variability, specimens with PCA3 scores near the cut-off may yield a different overall interpretation upon repeat testing. 25-31 Positive - Result should be interpreted with caution. Due to normal test variability, specimens with PCA3 scores near the cut-off may yield a different overall interpretation upon repeat testing. >31 Positive - Result associated with increased probability of a positive biopsy for prostate cancer.
Interpretive Data:
The Progensa PCA3 assay is an in vitro nucleic acid amplification test utilizing target capture, transcription-mediated amplification, and a hybridization-protection assay for amplicon detection. PCA3 Score is calculated as the ratio of PCA3 RNA copies to PSA RNA copies, multiplied by 1000.
Comments:
Sensitivity and Specificity: 77.5 percent and 57.1 percent respectively (relative to prostate biopsy outcome), based on a PCA3 score cutoff value of 25.
Test Limitations:
This test should not be used for men with a result of Atypical Small Acinar Proliferation (ASAP) on their most recent biopsy. Performance has not been established in men who undergo a repeat biopsy less than THREE months or more than SEVEN years after their most recent negative biopsy. The effect of medications known to influence serum PSA levels or therapeutic and/or diagnostic procedures such as prostatectomy, radiation, or prostate biopsy that may impact the viability of prostatic tissue and PCA3 Score have not been evaluated.

Values obtained with different assay methods or kits cannot be used interchangeably. Results should be interpreted in correlation with clinical history and other relevant data.
Methodology:
Qualitative Transcription-Mediated Amplification
CPT Code:
81313