PCA3 NON-INVASIVE TEST FOR PROSTATE CANCER SCREENING
QUEBEC CITY – DiagnoCure, Inc., a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced today that its commercial partner, Gen-Probe Incorporated, has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its PROGENSA PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer. DiagnoCure holds the worldwide rights to the PCA3 biomarker and, in 2003, granted an exclusive sub-license to Gen-Probe for diagnostic applications.
“DiagnoCure and its shareholders have been waiting for this important announcement that represents a key milestone towards the commercialization of the PCA3 biomarker in the United States. Indeed, if and when the PROGENSA(R) PCA3 assay is approved by the FDA, Gen-Probe will be able to launch it in the U.S. with a sales and marketing program that could translate into a notable ramp-up of PCA3 sales,” stated Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure.
Gen-Probe is seeking FDA approval to use the PROGENSA(R) PCA3 assay to test urine samples from men who previously have had a negative prostate biopsy. In support of this objective, the company conducted a prospective, multicenter clinical study of the assay that enrolled 507 men. The trial began in August of 2009 and concluded in May of 2010. In its second quarter earnings call, Gen-Probe indicated that the results of this study are consistent with those of many other studies conducted to date, and stated that it intends to present the data at a future medical meeting.
The FDA has formally accepted Gen-Probe’s PMA filing, and has advised Gen-Probe that a meeting of the Medical Devices Advisory Committee’s Immunology Panel will be required to support approval of the PMA. No date for this meeting has been set.
PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing.
Data from approximately 30 peer-reviewed publications suggest that PCA3 testing, when used with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as identifying clinically relevant cancers that need to be treated, while minimizing unnecessary biopsies. Moreover, a recent European study suggested that PCA3 testing also could predict the outcome of initial biopsies in men suspected of having prostate cancer.
“DiagnoCure and its shareholders have been waiting for this important announcement that represents a key milestone towards the commercialization of the PCA3 biomarker in the United States. Indeed, if and when the PROGENSA(R) PCA3 assay is approved by the FDA, Gen-Probe will be able to launch it in the U.S. with a sales and marketing program that could translate into a notable ramp-up of PCA3 sales,” stated Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure.
Gen-Probe is seeking FDA approval to use the PROGENSA(R) PCA3 assay to test urine samples from men who previously have had a negative prostate biopsy. In support of this objective, the company conducted a prospective, multicenter clinical study of the assay that enrolled 507 men. The trial began in August of 2009 and concluded in May of 2010. In its second quarter earnings call, Gen-Probe indicated that the results of this study are consistent with those of many other studies conducted to date, and stated that it intends to present the data at a future medical meeting.
The FDA has formally accepted Gen-Probe’s PMA filing, and has advised Gen-Probe that a meeting of the Medical Devices Advisory Committee’s Immunology Panel will be required to support approval of the PMA. No date for this meeting has been set.
PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing.
Data from approximately 30 peer-reviewed publications suggest that PCA3 testing, when used with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as identifying clinically relevant cancers that need to be treated, while minimizing unnecessary biopsies. Moreover, a recent European study suggested that PCA3 testing also could predict the outcome of initial biopsies in men suspected of having prostate cancer.
NEW INFORMATION REGARDING THE POTENTIAL FOR LIFE THREATENING
CONSEQUENCES OF PROSTATE BIOPSIES
In May 2011 Bloomberg News published an article detailing the seldom mentioned potential for hospitalization and on rare occasions death as a result of prostate biopsies. I know first hand since I was within one hour of death because of my personsal biopsy. Anyone contemplating a biopsy should read this article and play the video. Please go to:
http://noir.bloomberg.com/apps/news?pid=email_en&sid=ajM7So2qL2pw.
http://noir.bloomberg.com/apps/news?pid=email_en&sid=ajM7So2qL2pw.