MYGN Unveils Prolaris Study Results
Myriad Genetics Inc. (MYGN) recently announced its intention to present data from four clinical studies undertaken with Prolaris, at the 14th Annual Meeting of the Society for Urologic Oncology (:SUO) in Bethesda, MD. Additionally data from two new clinical studies on the Prolaris test will also be revealed at the same event. The event will also see the presentation of a new study, focused on renal cell carcinoma.
Myriad’s Prolaris is a genomic test applied to predict cancer-specific disease progression and mortality based on an analysis of 46 cell cycle progression genes. It is the only test available that shows prognostic value in both pre and post prostatectomy settings. Currently, it is approved by the FDA for use in low-risk men with a Gleason score of 6, as well as for post-prostatectomy patients who are categorized in the high-risk zone for prostate cancer recurrence.
The Prolaris test is expected to be an effective tool for physicians to identify patients who are vulnerable to biochemical recurrence. It should help them administer suitable treatment for prostate cancer in men and customize treatment as per the requirement of the patient, as well as determine whether prostatectomy is at all required.
This eradicates the obligation to rely on prostatectomy alone for monitoring patients till biochemical recurrence takes place.
The first research study covering 294 patients with localized prostate cancer was conducted to determine Prolaris’ clinical utility in guiding treatment decisions for patients diagnosed with prostate cancer. The study revealed that 55% of tests had a mortality risk score that was either higher or lower than what they expected and 32% of test results lead to a definite or possible change in treatment plan.
PROCEDE 500 is another large scale clinical utility study that is currently in progress. An interim analysis of the study showed that physicians were ready to change the course of treatment in 65% of cases.
The objective of the second study was to determine the accuracy of the Prolaris test in predicting the aggressiveness of prostate cancer. A sample of 1,604 patients showed that 27.9% of men were found to have a less aggressive cancer, while 27.6% had a more aggressive cancer-type. Consequently, a lower risk group was assigned to the patients found to have a less aggressive cancer.
The third study focused on the ability of the Prolaris test in predicting cancer progression, as measured by both biochemical recurrence and metastatic disease after radical prostatectomy. The study concluded the fact that the Prolaris test was a strong predictor of biochemical recurrence and was the strongest predictor of metastatic disease. The final study involved evaluation of the prognostic value of a cell cycle progression test on patients with renal cell carcinoma and needs further investigation.
Currently, Myriad Genetics carries a Zacks Rank #2 (Buy). Investors interested in the industry may also consider stocks like Actelion Ltd. (ALIOF), Heska Corp. (HSKA) sport a Zacks Rank #1 (Strong Buy) and AMAG Pharmaceuticals, Inc. (AMAG) carrying a Zacks Rank #2 (Buy).
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