The Prostatype® Test System is a new gene test that provides:
- Prognosis of survival
- Decision support for various treatment options
The Prostatype® Test System combines gene expression information with the currently used clinical parameters (PSA, Gleason Score, Tumor Stage, and age). Based on a unique database containing authentic information from 600 historic prostate cancer patients, the Prostatype® Test System provides decision support for patients and doctors when making a treatment decision. This reduces the risk of over- or undertreatment and can postpone repeated biopsies.
The Prostatype® Test System uses formalin-fixed paraffin-embedded (FFPE) prostate cancer core needle biopsies as a starting material. Existing prostate cancer biopsies can be used to perform the test, no additional biopsies need to be taken. Several thin tissue sections are prepared and one of the sections is stained with hematoxylin and eosin while the rest of the sections remain unstained. A pathologist (or health care professional with equivalent education) marks and calculates the cancer area on the stained slide. In the following step, this slide is used as a template. By overlapping it with the unstained sections, the cancer area can be identified and scraped into a reaction vial. Total RNA is extracted from the scraped tissue using the commercially available Maxwell 16 LEV RNA FFPE Purification Kit (Promega). The purified RNA is immediately used for qPCR analysis using the Prostatype® RT-qPCR Kit. The gene expression values of the three biomarker genes (IGFBP3, F3 and VGLL3) are entered into our CPMA database together with clinical parameters (Age at diagnosis, Gleason Score, PSA value, and tumor stage). The software conducts a database search and calculates the P-Score. Moreover, it identifies the three most similar historical reference patients. Altogether the turnaround time of the test is 2-3 days. Results