Prostate Cancer (PCA3) screening, urine

Reference values and Delivery Time Modification

Test code: 1318

Effective update from 20/01/2017

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The PCA3 Score is intended for use in conjunction with standard-of-care diagnostic algorithms as and aid in the diagnosis of prostate cancer. A PCA3 Score greater or equal to 25 indicates an over-expression of PCA3 mRNA with an increased probability of a positive repeat biopsy than a PCA3 Score < 25 and an active surveillance with a prostatic biopsy is appropriate. The PCA3 Score cut-off of 25 provides the optimal balance between sensitivity (64%) and specificity (76%).                   Delivery term: 20 days

The PCA3 gene is a prostate specific gene that shows a significant overexpression in prostatic carcinoma cells (prostate carcinogenic cells express 60 to 100 times more ARNm of PCA3 than normal cells). Progensa test is highly specific for quantifying the expression of PCA3 and PSA ARNm genes in prostate cells. The assessment of PSA ARNm allows estimating the quantity of prostatic cells in the patient sample and is used as an internal control of the sample.  The PCA3 index is calculated by the following formula (PCA3-ARNm/PSA-ARNm)x1000. At higher outcomes, higher is the probability for positivity in prostate cancer. A cutoff value of 35 is taken to report a positive result. This cutoff has the best sensitivity vs. specificity relation (48% vs. 79%). Values under 30 indicate a low probability of prostate cancer being the probability lower at lower values. .                Bibliography:  - Bussemakers MJ et al. Cancer Res 1999;59(23):5975-9. - Groskopf J et al. Clin Chem 2006;52(6):1089-95. - Hessels D et al. Eur Urol 2003;44(1):8-15. - Groskopf J et al. Posterpräsentation EUA 2007. - Haese et al. Posterpräsentation EAU 2007.           Delivery term: 21 days