According to a report today on Xconomy.com, the U.S. Food & Drug Administration has approved the Progensa® PCA3 test developed by Gen-Probe.
Filed under: Diagnosis, Risk | Tagged: biopsy, Diagnosis, PCA3, risk, test | 4 Comments »
FDA approves Gen-Probe PCA3 test (Progensa)
Posted on February 15, 2012 by Sitemaster
FDA Advisory Board to review Gen-Probe’s PCA3 test next year
Posted on August 30, 2011 by Sitemaster
The possibility of approval of the Progensa® PCA3 test here in the USA any time soon appears to have received a setback.
Filed under: Diagnosis, Management, Risk, Treatment | Tagged: Gen-Probe, PCA3, Progensa | Leave a Comment »
Health Canada approves use of Gen-Probe PCA3 test
Posted on August 18, 2011 by Sitemaster
“New” urine test combines data from PCA3 and gene fusion to predict prostate cancer risk
Posted on August 4, 2011 by Sitemaster
There is a lot of media coverage from late yesterday about a “new” urine test for diagnosis of prostate cancer that is being developed by the University of Michigan in combination with San Diego-based Gen-Probe. Whether the actual value of the test can live up to the media coverage is going to take a while [...]
Filed under: Diagnosis, Risk | Tagged: biopsy, PCA3, risk, test, TMPRSS2:ERG | 1 Comment »
A three-marker algorithm for projecting prostate cancer risk, need for biopsy
Posted on June 9, 2011 by Sitemaster
A new study has suggested that a clinical algorithm that combines data on serum PSA with detection of TMPRSS2:ERG fusion and prostate cancer gene 3 (PCA3) in urine collected after a digital rectal exam (DRE) can predict prostate cancer on subsequent biopsy better than any one of the three potential markers alone.
Filed under: Diagnosis, Risk | Tagged: algorithm, biopsy, PCA3, PSA, risk, TMPRSS2:ERG | Leave a Comment »
The practical clinical value of the PCA3 test
Posted on April 19, 2011 by Sitemaster
The prostate cancer gene 3 or PCA3 test has been commercially approved in Europe as a test that provides relevant information associated with the need for a prostate biopsy. It is still awaiting approval in the USA.
Filed under: Diagnosis, Risk | Tagged: biopsy, Diagnosis, PCA3, risk | Leave a Comment »
PCA3, PSA, and free PSA in prediction of prostate cancer risk
Posted on December 1, 2010 by Sitemaster
A new study has suggested that, although the PCA3 test is slightly better than the total PSA test in prediction of risk for a positive biopsy finding, it is not necessarily always better than the free PSA test.
Filed under: Diagnosis, Risk | Tagged: biopsy, free, PCA3, positive, PSA, risk, total | 1 Comment »
Is PCA3 any more useful than a PSA test in the “real world”?
Posted on November 15, 2010 by Sitemaster
At major academic medical centers and in at least one large clinical trial, the prostate cancer gene 3 or PCA3 test has appeared to work better than the total serum PSA test as a means to predict the presence of prostate cancer on biopsy.
Filed under: Diagnosis, Risk | Tagged: Diagnosis, PCA3, prognosis, PSA, risk | Leave a Comment »
What to make of a very high PCA3 test result?
Posted on October 28, 2010 by Sitemaster
The prostate cancer antigen 3 or PCA3 test is already widely used to further assess risk for prostate cancer in a man with a high PSA result (potentially indicative of risk for prostate cancer) but an initial negative biopsy. The “cut point” for re-biopsy is considered to be a PCA3 score of ≥ 35.
Filed under: Diagnosis, Risk | Tagged: biopsy, PCA3, re-biopsy, risk | 6 Comments »
Gen-Probe submits application to market Progensa PCA3 assay
Posted on September 22, 2010 by Sitemaster
According to a corporate media release, issued yesterday, Gen-Probe has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) seeking approval to market the company’s version of the PCA3 test, known as Progensa®.
Filed under: Diagnosis, Risk | Tagged: assay, Diagnosis, PCA3, Progensa, risk, test | 3 Comments »
The search for better diagnostic tests for prostate cancer
Posted on March 6, 2010 by Sitemaster
Three papers presented on Friday at the Genitourinary Cancers Symposium in San Francisco addressed the near-term development of tests that may be able to improve our ability to accurately diagnose clinically significant prostate cancer.
Filed under: Diagnosis, Risk | Tagged: Diagnosis, PCA3, risk, TMPRSS2:ERG | Leave a Comment »
More on the appropriate use of the PCA3 test
Posted on March 2, 2010 by Sitemaster
A new mini-review article in BJU International provides additional insights into the potential uses of the PCA3 test in clinical practice.
Filed under: Diagnosis, Management, Risk | Tagged: PCA3, prostate cancer gene 3, test | 3 Comments »
Johns Hopkins throws (some) cold water on possible use of PCA3 test
Posted on December 21, 2009 by Sitemaster
It has been hoped (at least by some) that a possible use of the prostate cancer gene 3 or PCA3 test — approved in parts of Europe but still in clinical trials in the US – would be as a better tool than PSA tests and annual biopsies to monitor patients on expectant management (active surveillance).
Filed under: Diagnosis, Management, Risk | Tagged: active surveillance, expectant management, PCA3, progression | 10 Comments »
The PCA3 test: how does it get used in practice?
Posted on December 18, 2009 by Sitemaster
The prostate cancer gene 3 or PCA3 test has been approved for clinical use in several European countries and is available but not yet approved for clinical use in the USA. However, knowledge about the most appropriate clinical uses for this test is still evolving.
Filed under: Diagnosis, Management, Risk | Tagged: Diagnosis, PCA3, risk | 8 Comments »
Gen-Probe starts clinical trial of PCA3 test in USA
Posted on August 28, 2009 by Sitemaster
Gen-Probe announced yesterday that it has begun a clinical trial designed to seek U.S. regulatory approval of the PROGENSA® PCA3 assay.
Filed under: Diagnosis, Risk | Tagged: clinical trial, PCA3, Progensa | 5 Comments »
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ongoing trials on the
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