PROGENSA PCA3 Assay Prescribing Information

(ChemotherapyAdvisor) – The U.S. Food and Drug Administration has approved PROGENSA PCA3, “the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy,” according to the assay’s manufacturer, Gen-Probe, San Diego, CA.

The PROGENSA PCA3 assay is an in vitro nucleic acid amplification test that detects Prostate Cancer Gene 3 (PCA3) messenger ribonucleic acid in male urine specimens following a digital rectal examination. These results are used to generate a PCA3 score: the higher the score, the higher the likelihood of a positive biopsy. The PCA3 score is intended for use in conjunction with standard-of-care diagnostic algorithms as an aid in the diagnosis of prostate cancer.

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A multicenter clinical study of PROGENSA PCA3 in 495 men recommended for repeat biopsy found the assay had a negative predictive value of 90%.

The PROGENSA PCA3 assay should not be used for men with atypical small acinar proliferation on their most recent biopsy; instead, these men should be treated following current medical guidelines. Assay performance has not been established in men for whom a repeat biopsy is not recommended.

Photo credit: FDA-approved PROGENSA PCA3 test helps determine need for repeat prostate biopsy. (PRNewsFoto/Gen-Probe Incorporated)

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