Diagnostic Test Developed to Predict Prostate Cancer Recurrence

A 46-gene prognostic test that quantitatively determines the risk of recurrence in patients who have undergone prostatectomy surgery has been developed.

For the first time, physicians now have a direct molecular measure of a prostate tumor's capacity to divide and grow by examining the mechanics of growth at the molecular level. Prolaris is Myriad Genetics, Inc.'s (Salt Lake City, UT, USA) eighth molecular diagnostic product and the first of two that are planned for launch in 2010.

"After undergoing a radical prostatectomy, men often worry about their continuing risk of cancer recurrence,” said Peter R. Carroll, M.D., M.P.H., professor and chair, urology, University of California, San Francisco (USA). "Prolaris may offer very important information to the patient and his physician about the risk of his cancer recurring.”

Prolaris is a molecular diagnostic assay that offers urologists a more accurate way of determining a prostate cancer patient's risk of recurrence. The new molecular diagnostic test is based on cell growth and tumor biology, and it provides rigorous, quantitative measures of the expression levels of multiple genes related to progression of the cell cycle.

The test identifies patients at low risk of disease recurrence with 95% certainty giving these men confidence that additional aggressive treatment with the accompanying toxicity and adverse events is likely unwarranted. Conversely, men with high Prolaris scores would be considered for more intensive screening and adjuvant therapy to address their more aggressive disease.

The company is performing additional clinical validation studies to expand the usefulness of the test. In one such recently completed study of 365 prostate cancer patients, 98.5% of prostate cancer patients with a low (favorable) Prolaris score survived their disease after 10 years, compared to 57.6% of the patients receiving a high (unfavorable) score who died of prostate cancer within 10 years.

"Prolaris is a valuable additional tool that will enable urologists to provide an accurate, individualized recurrence risk score to men who have undergone a radical prostatectomy,” stated Mark C. Capone, president, Myriad Genetic Laboratories, Inc. "We view Prolaris as the first of a strong emerging stable of RNA signature tools based on fundamental tumor biology, which Myriad will offer to the urology/oncology community.”

In the United States, 192,000 men are diagnosed with prostate cancer early and 80,000 men will undergo a radical prostatectomy, a surgical procedure that removes the prostate gland and some surrounding tissue. Approximately 35% of these men will eventually have a biochemical recurrence indicating the return of their prostate cancer. Current models based on clinical variables cannot effectively predict in which of these men the disease will recur.

Myriad will introduce Prolaris to urologists and oncologists through its established oncology sales force and new urology sales team in March 2010. The clinical validation and scientific data supporting the test were presented at the 2010 Genitourinary Cancers Symposium on March 5-7, 2010, in San Francisco, CA, USA.

Myriad Genetics is a molecular diagnostic company focused on developing and marketing novel predictive medicine, personalized medicine, and prognostic medicine products.

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