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- PROGENSA® PCA3
Prostate cancer gene 3 (PCA3) is strongly expressed in 95% of primary prostate cancer specimens. The PCA3 test is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men age 50 or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care. The PCA3 result provides a risk assessment of a positive biopsy.
This assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy. Men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.
The ProgensaA® PCA3 assay has the following performance characteristics using the PCA3 score cutoff value of 25 for this patient population: 77.5% sensitivity, 57.1% specificity, 90% negative predictive value and 33.6% positive predictive value.
Target capture, transcription-mediated amplification (TMA) and hybrid protection assay (HPA)
3 mL (Urine specimen fluid level must be between the black lines on the urine transport tube.)
Before collection, the patient should undergo an attentive digital rectal exam (three strokes per lobe).
1. Collect a first-catch (approximately 20 to 30 mL of the initial stream) urine sample in a urine collection cup after DRE has been performed. Urine sample should be processed immediately following steps 2 and 3.
2. Invert the sample five times to resuspend the cells. Transfer 2.5 mL of urine (fill until the fluid level is between the black lines) into the urine specimen transport tube using the disposable pipette provided.
3. Recap the urine specimen transport tube tightly and invert five times to mix.
Processed urine specimens must be shipped at 30°C or below (may be frozen) and should be received by the test facility within five days of collection.
Causes for Rejection
Specimen volume <2.5 mL; incorrect collection kit; specimen received after five days
Please direct any questions regarding this test to customer service at 800-345-4363.