4. Hessels D, Gunnewiek J, van Oort I, et al. DD3PCA3-based mole- Indications for PROGENSA™ cular urine analysis for the diagnosis of . Eur Urol. PCA3 Test 2003;44:8–16. 5. Groskopf J, Aubin SM, Deras IL, et al. APTIMA PCA3 molecular Focus on... urine test: development of a method to aid in the diagnosis of . Clin Chem. 2006;52:1089-95. PSA 6. Marks LS, Fradet Y, Deras IL, et al. PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy. Urology. 2007;69:532-5. Biopsy

Positive Negative biopsy biopsy Contact

Cancer PCA3 test Biomnis Ireland diagnosis Three Rock Road Sandyford Industrial Estate PCA3 Ratio < 35 PCA3 Ratio > 35 Sandyford Dublin 18 Low probability High probability Tel.: (01) 295 8545 to detect cancer to detect Fax: (01) 295 5399 via biopsy cancer via E-mail: [email protected] biopsy Web: www.biomnis.ie

Pre-analytical conditions: after DRE, collect 20 to 30 ml of first catch urine. Transfer 2 x 2,5 ml into 2 tubes of transport medium. Sample stability: samples are stable for 7 days TM between 8°C and 30°C, or for 14 days between 2°C and 8°C. Test Progensa Price: Please contact Biomnis Ireland for pricing details. PCA3 for better evaluation of References prostate cancer cancer risk

1. Bussemakers M, van Bokhoven A, Verhaegh G, Smit F, Karthaus H, Schalken J. DD3: a new prostate-specific gene, highly over expressed in prostate cancer. Cancer Res. 1999;59:5975–5979. 2. Eggener S, Roehl K, Catalona W. Predictors of subsequent prostate cancer in men with a prostate specific-antigen of 2.6 to 4.0 ng/mL and an initially negative biopsy. J Urol. 2005;174:500–504. 3. Fradet Y, Saad F, Aprikian A, et al. uPM3, a new molecular urine test for thedetection of prostate cancer. Urology. 2004;64:311–316. Prostate cancer detection PSA test has low sensitivity and specificity (resulting Performing PROGENSA™ PCA3 in numerous false negatives, false positives triggering unnecessary biopsies). test Prostate cancer is the most commonly found There is no PSA threshold allowing both sensitivity cancer in men above 50 years old. It represents and specificity to 100%. the second highest cause of cancer related 1 - Perform DRE: apply enough pressure on prostate mortality. Each positive PSA test triggers one or several so as to release maximum prostate cells into urine. biopsies which in turn: For an early diagnosis, it is recommended that men between 50 and 75 years old are subjected to a Can cause elevated costs for healthcare digital (DRE) and have Prostatic providers. Specific Antigen (PSA) level evaluated. For men with Are uncomfortable for patients and a source a family history or with risk factors such as West-Indian of anxiety and apprehension. origins,screeningis recommended as early as 45 years Represent a risk of infection and a risk of old. haemorrhage. Should DRE and/or PSA levels be abnormal, it is necessary to perform a trans-rectal ultrasound 2 - Collect and transfer urine into transport medium guided in order to assess the PROGENSA™ PCA3 test: Benefits at room temperature, and send to the laboratory. presence of prostate cancer. In the case of a positive biopsy, diagnosis is assessed and treatment started according to PROGENSA™ PCA3 test is used as: Interpretation: PCA3/PSA ratio age, life expectancy and cancer aggression An improved method of prostate cancer diagno- (surgery, radiotherapy, hormonal therapy or sis. surveillance). PCA3/PSA ratio < 35 Low probability of cancer A prognostic tool for patients with abnormal PSA diagnosed with 2nd biopsy. In the case of a negative biopsy, surveillance levels and normal biopsy. PCA3/PSA ratio > 35 High probability of cancer. via PSA levels and repeated biopsies, A tool for clinicians in deciding whether or not PCA3 ratio is independent from prostate volume. according to age and/or PSA level evolution biopsies should be repeated. (increasing PSA kinetics or PSA velocity).

Probability ratio of 125 65 120 60 115 Limits of PSA testing: DD3... DD3PCA3… PCA3 gene 55 positive biopsy 105 50 95 45 sensitivity & specificity 85 85 40 75 35 In 1999, a pseudo gene called DD3 was discovered, 65 55 30 later called PCA3 (prostate cancer gene 3). 45 25 PSA levels are prostate specific but not cancer PCA3 results 35 35 20 PCA3 expression is restricted to prostate cells. 34 10 Limit = 35 specific. Other pathologies may cause elevated PSA 30 25 18 level, such as benign prostatic hyperplasia (BPH), PCA3 has a very low expression in healthy prostate 20 20 15 22 infections or inflammations. cells. 10 24 10 9 About 15 % of are observed in patients Probability ratio of 8 26 7 28 6 PCA3 is overly expressed in prostate cancer cells negative biopsy 5 30 with a normal PSA level, that is < 4.0 ng/mL. 4 4 40 (~60 to 100 times increase).