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U.S. Department of Health and Human Services

Medical Devices

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PROGENSA® PCA3 Assay - P100033

Two boxes of the Progensa automated molecular test.

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: PROGENSA® PCA3 Assay
PMA Applicant: Gen-Probe Incorporated
Address: 10210 Genetic Center Drive, San Diego, CA 92121 US
Approval Date: 02/13/2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100033a.pdf

What is it? The PROGENSA® PCA3 Assay is an automated molecular test (assay) that helps physicians determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.

How does it work?

  • The urologist conducts a digital rectal exam (DRE) and immediately afterwards the patient collects a 20-30 mL first catch urine. The DRE releases prostate cells in the first catch urine. The urologist’s office processes the urine and sends the specimen to a laboratory for testing.
  • At the testing laboratory, a trained medical professional measures the prostate specific antigen (PSA) ribonucleic acid (RNA) and prostate cancer gene 3 (PCA3) RNA molecules and calculates the PCA3 Score (a ratio of PCA3 RNA to PSA RNA).
  • A urologist reviews the results together with other patient information. A negative PCA3 score helps the urologist determine whether a repeat biopsy is not required.
  • If the test PCA3 Score is negative, then there is less likelihood of a positive biopsy at the repeat biopsy.

When is it used? This test is used in men 50 years of age 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, before considering the use of the PROGENSA® PCA3 Assay.

What will it accomplish? This test helps to determine if a repeat biopsy would not be required when used with other clinical information and laboratory tests in patients with previously negative prostate biopsies; and for whom a repeat biopsy would be recommended. As a result, some patients who would otherwise be recommended for a biopsy may be saved from unnecessary biopsies and related complications.

When should it not be used? The test should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy.

Additional information: The Summary of Safety and Effectiveness and labeling are available online.

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