Prolaris® Prostate Cancer Genomic Test
Use
Prolaris® Biopsy is intended for in vitro diagnostic analysis of FFPE prostate tumor biopsies to help determine a patient’s 10-year risk of metastatic disease with definitive therapy and 10-year risk of disease-specific mortality if conservatively managed. The test is also intended to help identify whether a patient may be appropriate for active surveillance, single-modality treatment, or multimodality treatment, and should be used alongside clinical evaluation and other diagnostic information.
Special Instructions
Acceptable specimens are FFPE prostatic adenocarcinoma biopsy tissue submitted as blocks or slides. Blocks (or slides) are shipped overnight with an ice pack to Myriad for analysis. Ordering clinicians must provide required clinical variables on the test request form to support combined risk scoring, and Medicare ordering includes CTR program requirements on the TRF.
Limitations
Performance characteristics have not been established for tissues other than human FFPE prostate tumor specimens; other tissue types are not accepted. The assay is not validated for tumor samples from individuals with total PSA >100 ng/mL. FFPE preservation can cause RNA degradation, which may result in insufficient RNA quality/quantity for analysis, and results should be interpreted with other clinical and diagnostic information. Samples may be canceled for inappropriate tumor type, prior therapy before biopsy, prior freezing, TURP samples, insufficient tumor quantity/quality, or insufficient clinical information.
Methodology
PCR-based (RT-qPCR)
Biomarkers
Result Turnaround Time
2 weeks
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
FFPE tissue block
Minimum Volume
If block not available, one 3–5 µm H&E slide followed by five consecutive 4–5 µm unstained slides may be acceptable
Container
FFPE tissue block
Collection Instructions
Submit FFPE prostatic adenocarcinoma biopsy tissue (block or slides).
Causes for Rejection
Inappropriate sample types or conditions may cause cancellation, including tumors other than prostatic adenocarcinoma (e.g., small cell carcinoma or sarcoma), previously frozen samples, patients receiving cancer-reducing therapy prior to biopsy, TURP samples, insufficient clinical information, insufficient tumor quantity (<0.5 mm linear tumor and/or <50% tumor), or insufficient quality (including shipping damage).