Progensa PCA3 assay

At Hologic, we are firmly focused on making a difference in the health of the world, and our molecular diagnostic assays allow us to do just that.

Our Progensa PCA 3 assay is the first urine-based molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy, providing clinically important information to help physicians make better, more informed decisions in the diagnosis of prostate cancer.

About

PCA3 is a prostate specific gene that is highly over-expressed in prostate cancers. The Progensa PCA3 assay from Hologic is an in vitro nucleic acid amplification test that measures the concentration of prostate cancer gene 3 (PCA3) and prostate-specific antigen (PSA) RNA molecules in post-digital rectal exam (DRE) male urine specimens.

The assay calculates the ratio of PCA3 RNA molecules to PSA RNA molecules to generate a PCA3 score. Studies have shown that because the PCA3 gene is highly specific for prostate cancer, the PCA3 score predicts the results of repeat biopsies more accurately than traditional serum PSA testing in men who have had one or more previous negative prostate biopsies.

When used with other patient information, our Progensa PCA3 assay may help address some challenges urologists face with identifying prostate cancers, while reducing unnecessary repeat biopsies. 

For the most current information on the clinical  performance and utility of the Progensa PCA3 assay, please visit www.PCA3.org.*  

*Materials contained on the PCA3.org website ("Content") are compiled from a variety of sources and are for informational purposes only.  The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Reliance on any Content provided on PCA3.org, is solely at your own risk.

Prevalence

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer).

One in six American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS estimates that about 241,000 Americans were newly diagnosed with prostate cancer in 2011, and that approximately 34,000 men died from the disease.

Products

Description

Quantity

Catalog

Progensa PCA3 assay kit

100 tests

302355

Progensa PCA3 urine specimen transport kit

50 tubes

302352

Progensa PCA3 proficiency panels

16 tests

302350

Progensa PCA3 specimen diluent kit

14 tests

302351 

   
Regulatory

The Progensa PCA3 assay was approved by the FDA in 2012.

The FDA approval of the Progensa PCA3 assay was based on a clinical study that began in August 2009 and concluded in May 2010. The study enrolled 495 eligible men at 14 clinical sites. Hologic submitted a Premarket Approval Application (PMA) to the FDA in August 2010 and the Progensa PCA3 assay was approved in February 2012.

In the clinical study, the Progensa PCA3 assay had a negative predictive value of 90%, meaning that a negative Progensa PCA3 score predicted a negative prostate biopsy 90% of the time.

Intended Use: The Progensa PCA3 assay is an in vitro nucleic acid amplification test. The assay measures the concentration of prostate cancer gene 3 (PCA3) and prostate-specific antigen (PSA) RNA molecules and calculates the ratio of PCA3 RNA molecules to PSA RNA molecules (PCA3 score) in post-digital rectal exam (DRE) first catch male urine specimens. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy 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 consideration of Progensa PCA3 assay results.

A PCA3 score <25 is associated with a decreased likelihood of a positive biopsy. Prostatic biopsy is required for diagnosis of cancer.

Black Box Warning: The Progensa PCA3 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.

Warning: The clinical study of the Progensa PCA3 assay only included men who were recommended for repeat biopsy. Therefore, the performance of the assay has not been established in men for whom a repeat biopsy was not already recommended.

For additional availability in other countries please contact your local sales rep or distributor.