Test Name: PCA3 (Prostate Cancer Antigen 3)

Methodology: Transcription Mediated Amplification (TMA) and Hybrid Protection Assay (HPA)

Test Description

Adjunct to serum PSA for risk stratification of patients undergoing repeat prostate biopsy. The PCA3 test is a molecular assay that detects the mRNA expression of the DD3 gene expressed in prostate cells. In recent studies it was shown to have a specificity of 78% and a sensitivity of 57% in cancer vs. non-cancer.

Specimen Requirements

PROGENSA PCA3 Urine Specimen Transport Tubes required for processing.

Storage and Transport

Perform an attentive DRE immediately prior to specimen collection (the specimen should be collected within approximately 1 hour of DRE). Instruct patient to collect the FIRST 20 - 30 mL of voided urine following the DRE. Process the specimen as follows within 4 hours of collection (if specimen cannot be processed within 15 minutes, store refrigerated or on ice): 1) Invert specimen cup 5 times to re-suspend cells. 2) Add 2.5 mL of urine to each of two GEN-PROBE PROGENSA PCA3 Urine Specimen Transport Tubes. Do NOT puncture the foil seal on the cap of the Transport Tube. The specimen volume should fall between the two black fill lines on the Transport Tube. 3) Tightly re-cap each Urine Transport Tube and gently invert 5 times to mix. The specimen is now a "processed" urine specimen. Refrigerate. Refrigerated specimens must be received by Lab within 4 days of collection. For longer storage, freeze and ship specimen on dry ice. Include serum PSA result and patient history with the specimen.

Specimen Rejection Criteria

Click here to reference the specimen rejection criteria.

Turn Around Time (TAT): 5 - 8 Days

CPT Codes*: 81313

*The CPT codes provided with our Test Descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.