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How it works
Prostate tissue is diagnosed as cancerous. The healthcare provider submits the test order to the pathology lab
Prostate tissue sample is prepared and packaged following the instructions inside the transport kit
Patient tissue sample is then analyzed at our state-of-the-art facility and results are ready in around 2 weeks
How to select the best tissue sample
- Select the cancerous biopsy block with the highest amount of highest Gleason-grade Adenocarcinoma
- Block must be fixed in neutral buffered formalin. To confirm is an alternative fixative is accepted, please call Customer Service at 1-855-469-7765
- For Prolaris biopsy submissions, radical prostatectomy or TURP specimens are not accepted.
- Only the minimum required tissue will be used in our analysis. All blocks will be returned once reporting is complete. Unused slides will not be returned.
- While both blocks and unstained slides are accepted, blocks are always preferred.
Optimizing pathology sample submissions
Only a small amount of quality tumor is required to run Prolaris. Several factors can affect the quality and usability of the sample. Learn more about how you can optimize the sample selection and reduce test cancellations.
A greater number of positive cores increases the likelihood of sample acceptance, because tumor can be combined from multiple cores. With a single positive core, sample acceptance is most correlated with the percentage of tumor in the core (the higher the %, the more likely the acceptance).
Cores with <10% involvement may not meet the 0.5mm length requirement. This can be remedied by combining tumor from multiple cores. (cores range in length from 5 mm to 15mm).
The procedure for cutting tumor sections to diagnose cancer varies greatly. Most labs cut between 2 and 6 levels. The more levels cut, the less amount of tissue remains in the block. Many labs discard the intervening sections between the sections used for diagnosis. The percentage of the core remaining after slides are cut for diagnosis varies from 0% (no tissue) to 50%.
In addition to 0.5mm continuous tumor length requirement, samples must also contain 75% or greater tumor glands of macro dissectible tumor tissue. Often prostate needle biopsies contain small foci of invasive cancer intermixed with normal tissue, which makes macro dissection of tumor difficult.
Samples must be fixed in a formalin-based fixative. To confirm an alternate fixative, please contact Customer Service.