FDA approves Gen-Probe PCA3 test (Progensa)

According to a report today on Xconomy.com, the U.S. Food & Drug Administration has approved the Progensa® PCA3 test developed by Gen-Probe.

Another investigational test may refine data on need for prostate biopsy

A newly published paper  in the Journal of Urology describes a multi-center, prospective study of the potential of the investigational, urine-based, ProCaM™ assay as a test to offer improved evaluation of the need for prostate biopsy among men with an initial total serum PSA level between 2 and 10 ng/ml.

Canadian company claims new test is 600% more accurate than free PSA test

According to a media release issued by the Canadian company BioCurex earlier today, its new RECAF™ test “outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies.”

“New” urine test combines data from PCA3 and gene fusion to predict prostate cancer risk

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 [...]

“Five prostate cancer diagnostics to watch”

The FierceBiomarkers e-newsletter has compiled a brief report with the above title that may be of interest to some of our readers.

87 percent of Americans willing to be tested for prostate cancer (maybe)

According to a report on the Scientific American web site, 87 percent of respondents to a survey conducted by researchers at Tufts Medical Center would be willing to have a hypothetical “predictive” test for prostate cancer.

Initial data from Genomic Health test for recurrent or progressive prostate cancer

According to a media release this morning from Genomic Health, Inc., initial data from a large study has identified 295 genes that are strongly associated with clinical recurrence following radical prostatectomy.

How often is a PSA test really needed to identify risk?

A re-analysis of data from the Antwerp (Belgium) section of the European Randomized Study of Screening for Prostate Cancer  (ERSPC) has offered us some further insight into the frequency of PSA testing necessary to identify less and more aggressive forms of prostate cancer.

Prolaris: prognostically accurate but of limited utility?

According to a media release from  Myriad Genetics, the company’s investigational genetic test (Prolaris™) can accurately predict prostate cancer-specific mortality at 10 years in men known to have clinically localized prostate cancer.

Another new test that might be able to limit need for biopsies

Reports on Reuters and on HealthDay state that a company called Oxford Gene Technology has developed a new type of test with the potential to distinguish indolent forms of prostate disease from prostate cancer.

Gen-Probe submits application to market Progensa PCA3 assay

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®.

Health, technology, cost, and the PSA test

An editorial commentary printed in today’s New York Times is focused on an estimate by the US Congressional Budget Office that “an astonishing half or more of the increased spending for health care in recent decades is due to technological, surgical and clinical advances.”

Genetic testing for prostate cancer “in the real world”

Over the past few months, the US Food and Drug Administration (FDA) has issued a slew of letters to companies marketing tests designed to provide consumers with information about their genetic profile and their risks for certain types of disease.

New monoclonal antibody can detect ERG oncoprotein in prostate cancer patients

A media release from the Uniformed Services University of the Health Sciences last week announced the development of a highly specific assay for the detection of ERG oncoprotein. The assay is based on the development of an anti-ERG monoclonal antibody that appears to be capable of detecting the presence of ERG oncoprotein with > 99 percent accuracy.

New form of PSA test is 1,700 times more sensitive

Data just published in Nature Biotechnology suggests that a new type of PSA test developed by a company called Quanterix is 1,700 times more sensitive than older, standard PSA detection methods used in clinical laboratories.

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