Studies Back Gen-Probe’s Prostate Cancer Test

Eight studies presented this week at the American Urological Association Annual Meeting suggest that Gen-Probe’s investigational test for the prostate cancer gene PCA3 may address some of the major challenges faced by urologists when diagnosing the disease. According to a press release, the company is now gearing up for a clinical study of their PROGENSA diagnostic assay.

The PCA3 gene is over-expressed in more than 90 percent of prostate tumors, indicating that it may be a strong biomarker for prostate cancer. Data on PCA3 has been published in approximately 17 peer-reviewed publications. Researchers found that PCA3 was correlated with cancer aggressiveness, tumor volume, and the probability of a positive initial prostate biopsy in men with elevated serum PSA levels. They also found that PCA3 increased the accuracy of a two-dimensional graph that predicted which men would develop low-grade or low-volume prostate cancer. The studies found that PCA3 more accurately predicted the results of repeat biopsies than the traditional prostate-specific antigen (PSA) test. Recent studies have questioned the efficacy of the PSA test; one study published in the New England Journal of Medicine found that the PSA test led to more diagnoses but had a limited effect on prostate cancer deaths.

Gen-Probe, based in San Diego, anticipates that their PROGENSA diagnostic test will help urologists to accurately identify potentially aggressive cancers while minimizing “false positive” results that can lead to overtreatment. Bolstered by the research data, Gen-Probe plans to start a clinical study of PROGENSA in the third quarter of 2009. The new study may involve over 500 men, all of whom have had a negative prostate biopsy. PROGENSA is the first urine-based molecular diagnostic test for prostate cancer. It is already available in Europe, but has yet to be approved by the U.S. Food and Drug Administration.

Some other companies working in the prostate cancer field include:

Envisioneering Medical Technologies, which has developed a 3-D imaging system for prostate imaging and targeted biopsy.

Aureon Laboratories, whose multi-element pathology platform aims to predict the occurrence of prostate cancer in low- to medium-risk patients.

Endocare, which is developing minimally invasive ablation therapies to treat prostate cancer.

Trod Medical, whose Encage technology seeks to treat prostate cancer through radio frequency and image guidance.

Stage I Diagnostics, which identifies tumor-associated antibodies for the early diagnosis of prostate cancer.

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