Test Overview
Test Methodology

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

Test Usage

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.

Reference Range *

The PCA3 score is reported as a quantitative PCA3/PSA mRNA ratio x 1000 to normalize PCA3 to the amount of prostate RNA present in the urine sample. Cases with insufficient PSA mRNA are considered inconclusive. A score equal to or greater than 25 is considered positive. A positive result is associated with increased likelihood of a positive biopsy for cancer.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Details
Analytic Time

4 - 7 days

Soft Order Code
PCA3
MiChart Code
Prostate Cancer Antigen 3 (PCA3)
Synonyms
  • PCA3
  • PCA3 (Prostate Cancer Antigen 3)
  • Prostate Cancer Gene 3
  • Differential Display Code 3 (DD3)
  • PCA-3
  • PCA3S
Laboratory
MCTP Molecular Testing Lab
Section
MCTP Molecular Testing Lab
Test Updated
Update Type
Test Down or Delayed
Specimen Requirements
Collection Instructions

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 and process within 4 hours): 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 must 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; do not shake or vortex. The specimen is now a "processed" urine specimen. Refrigerate. Refrigerated specimens must be received by MLabs within 5 days of collection. For longer storage, freeze specimen at -20 degrees C and ship specimen on dry ice. Frozen specimens are stable for 90 days at -20 degrees C. Include serum PSA result and patient history with the specimen.
Obtaining informed consent from the patient prior to genetic testing is strongly recommended. If desired, a UMHS Request and Consent for Genetic Testing form can be obtained by contacting the MLabs Client Services Center at 800-862-7284 or online at https://mlabs.umich.edu/sites/default/files/2020-01/file/pci-mmgl_infor….

Special Handling

Attentive DRE must be performed immediately prior to specimen collection. Specimen must be processed within 4 hours of collection. Please refer to Collection Instructions for additional details.

Red Top Tube
Normal Volume
30 mL urine
Minimum Volume
5 mL urine
Storage Temperature
Room temperature (ambient): 24 hours, Refrigerated: 5 days, Frozen: 90 days.
Additional Information

A signed Advance Beneficiary Notice of Noncoverage (ABN) form - available at http://mlabs.umich.edu/files/pdfs/ABNEnglish2020v508-MLABS-PCA3.pdf - must accompany any samples sent for PCA3 or MiPS testing from Medicare patients when MLabs will be billing Medicare or the patient. By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

Billing
CPT Code
81313
Fee Code
10385
Pro Fee CPT
G0452-26
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