Transcription Mediated Amplification (TMA) and Hybrid Protection Assay (HPA)
Adjunct to serum prostate specific antigen (PSA) for risk stratification of patients undergoing prostate biopsy. MPS incorporates serum PSA, urine PCA3 score, and urine TMPRSS2: ERG score in logistic regression models to derive scores giving the risk of detecting high grade (Gleason score >7) prostate cancer on diagnostic needle biopsy.
The TMPRSS2: ERG score ranges from 0 to 100, with higher scores associated with an increased risk of high grade cancer on diagnostic biopsy. The MyProstateScore (MPS) report provides a high grade prostate cancer risk score, indicating the risk of high grade prostate cancer (Gleason score >7) on diagnostic needle biopsy.
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
10 - 14 days
- Prostate Cancer Risk Assesment
<img src=/static/apps/handbook/imgs/pca3andmips.png width=376><p style="font-size:20px;font-weight:bold">Specimen Collection </p>1. Perform an attentive DRE immediately prior to specimen collection (the specimen should be collected within approximately 1 hour of DRE):
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Apply firm pressure from the base to the apex and from the lateral to the medial line of the prostate.
Apply enough pressure to depress the surface slightly.
Perform 3 strokes for each lobe.
[/list]2. Instruct patient to collect the FIRST 20 - 30 mL of voided urine (do not catheterize) following the DRE.
3. <b>Process the specimen within 4 hours of collection </b> (if specimen cannot be processed within 15 minutes, store refrigerated or on ice and process within 4 hours).
<p style="font-size:20px;font-weight:bold">Specimen Processing </p>1. Invert specimen cup 5 times to re-suspend cells.
2. Add 2.3 mL of urine to each of two GEN-PROBE PROGENSA PCA3 Urine Specimen Transport Tubes. <span style="color:red">Do not puncture the foil seal on the cap of the Transport Tube. </span style="color:red"> 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 and ship specimen on dry ice.
4. Label each Transport Tube with the patient’s first and last names as well as a second identifier such as the patient’s date of birth or medical record number.
5. Include serum PSA result and patient history with the specimens.
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….
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.
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 MPS 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. Ordering clinician must provide serum PSA level (ng/mL) for a MPS report to be generated.