Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
Become a Member | Sign in
Home>News>This Article

FDA Approves Gen-Probe's PROGENSA® PCA3 Assay

Published: Wednesday, February 22, 2012
Last Updated: Wednesday, February 22, 2012
Bookmark and Share
Company reveals first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.

"When used in conjunction with other diagnostic information, our PROGENSA PCA3 assay provides clinically important information that helps physicians and their patients make better, more informed decisions about one of the most vexing problems in prostate cancer diagnosis," said Carl Hull, Gen-Probe's Chairman and Chief Executive Officer.  "From a commercial perspective, this is the third of four potential US regulatory approvals that we expect to generate a significant new sales growth cycle for the Company."

"Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue," said John Wei, MD, MS, Professor of Urology at the University of Michigan Health System.  "When evaluated with other risk factors, the PROGENSA PCA3 assay fills an important unmet clinical need by helping physicians identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy."

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 the current standard of care, before consideration of PROGENSA PCA3 assay results.  A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy.  A prostate biopsy is required to diagnose cancer.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,200+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Gen-Probe Files US Regulatory Application for PROGENSA® PCA3 Assay
New molecular test to help determine need for repeat prostate biopsies.
Monday, September 27, 2010
Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Nanomedicine for Breast Cancer Treatment
Using nanoparticles measuring only billionths of a meter in size, doctors are able to deliver drug molecules directly to the affected tissue.
MRIs for Fetal Health
Algorithm could help analyze fetal scans to determine whether interventions are warranted.
Illumina Contributes to ClinVar Database
The contribution includes variants of all classifications, from pathogenic to benign, identified during interpretation of whole genome sequences generated in the CLIA-certified, CAP-accredited Illumina Clinical Services Laboratory.
Signaling Pathway Could Be Key to Improved Osteoporosis Treatment
Inhibition of SIK2 enzyme both stimulates bone formation and reduces bone breakdown in animal model.
Supercomputers Could Improve Cancer Diagnostics
Researchers push the boundaries of cancer research through high-performance computing to map the human immunone.
Transgenomic, Precipio Diagnostics Merger
Merger will creates a robust diagnostic platform focused on improving accuracy of cancer diagnoses.
Inflammation Test May Predict Cardiovascular Disease
An assessment combining measures of immune-cell responsiveness predicted cardiovascular problems in individuals who likely would have slipped under the radar.
3D-Printing in Science: Conference Co-Staged with LABVOLUTION
LABVOLUTION 2017 will have an added highlight of a simultaneous conference, "3D-Printing in Science".
Potential Urine Test for CJD
Researchers at the Medical Research Council (MRC) Prion Unit at UCL have found that it may be possible to determine whether or not a person has sporadic Creutzfeldt-Jakob Disease (sCJD) by testing their urine for the presence of abnormal prion proteins.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos