Test Overview

Test Methodology

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

Test Usage

Adjunct to serum prostate specific antigen (PSA) for risk stratification of patients undergoing prostate biopsy. MiPS incorporates serum PSA, urine PCA3 score, and urine TMPRSS2:ERG score in logistic regression models to derive scores giving the risk of detecting prostate cancer and the risk of detecting high grade (Gleason score >6) prostate cancer on diagnostic needle biopsy. The MiPS prostate cancer risk score and the MiPS high grade prostate cancer risk scores are reported as risk percentages (<5% to >95%) with 95% confidence intervals.

Reference Range*

The TMPRSS2:ERG score ranges from 0 to >1,000, with higher scores associated with an increased risk of cancer on diagnostic biopsy. The Mi-Prostate Score (MiPS) report provides a prostate cancer risk score and high grade prostate cancer risk score, which range from <5% to >95%, indicating the risk of prostate cancer or high grade prostate cancer (Gleason score >6) on diagnostic needle biopsy, with 95% confidence intervals provided.

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

Test Details

Analytic Time

10 - 14 days

Synonyms

Synonyms

MIPS
TMPRSS2:ERG
T2ERG
T2:ERG
PCA3
Prostate Cancer Risk Assesment

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Laboratory

MCTP Molecular Testing Lab

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Specimen Requirements

Special Handing

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.

Normal Volume

30 mL urine

Minimum Volume

5 mL urine

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. Ordering clinician must provide serum PSA level (ng/mL) for a MiPS report to be generated.

Billing Information

Fee Codes


CPT Code

81313, 81479

New York State Approved

Yes

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