Renowned molecular diagnostics provider Myriad Genetics, Inc. MYGN recently revealed that it will present results from two clinical trials for its diagnostic assays, used to evaluate prostate and renal cancers. The data will be presented at the 2016 ASCO Genitourinary Cancers Symposium, which is currently in progress from Jan 7–9 at San Francisco.
The data from the twin trials reflect Myriad’s tireless efforts to develop innovative biomarker-based molecular diagnostics that will allow physicians to more efficiently tackle urological cancers and offer improved patient care in the process.
The Studies in Detail
In the first study, investigators examined 11, 665 prostate cancer patients to detect specific candidates eligible for active surveillance (AS), based on their combined clinical risk (CCR) score – a composite of Myriad’s Prolaris prostate cancer test. Per the trial outcome, 63% of the prostate cancer patient base qualified for AS. However, of these eligible candidates, 45% would not have been qualified for AS based on their clinical features alone, unless the CCR score associated with the Prolaris test was considered.
Consequently, these results reflect the significant prognostic information that Myriad’s Prolaris test offers at the time of diagnosis, unlike standard pathological measures of risk. Impressively, the CCR score allows 80% more prostate cancer patients to undergo AS, who would have otherwise deferred their treatment.
In the second study, the company evaluated the ability of its myPlan renal cancer test in predicting disease recurrence or disease-specific mortality in 305 renal cancer patients, who have undergone complete nephrectomy (removal of kidney). Per management, this outcome validates myPlan test as a significant predictor of key long-term oncologic outcomes, which traditional clinical parameters fail to assess in such renal cancer patients.
Moreover, combined with pathological parameters, Myriad’s myPlan score offers a composite prognostic score (PS) indicating a higher, three-fold increased recurrence risk in patients with a high PS compared to patients with a low score. Per management, this detection reflects the usefulness of Myriad’s myPlan renal cancer test score in improved clinical management of renal cancer patients, as patients with higher PS will get the necessary additional medical attention from their physicians.
Our View
In the current scenario, urologic cancer, apart from being a major cause of disability, has a high mortality rate. Prostate cancer (a form of urologic cancer) is the most common cancer type that affects American men. Bladder cancer (another form) is the fourth most common cancer among men and the ninth most common among women in the U.S. Moreover, more than 50,000 new cases of bladder cancer are diagnosed each year.
Given this significant market size, molecular diagnostic providers like Myriad hold great potential in the urologic oncology diagnostic market. Prolaris – the company’s first prostate cancer prognostic test – is a brainchild in this regard. Myriad is currently working on commercializing its myPlan renal cancer test – a similar prognostic test for renal cancer.
In Aug 2015, Myriad received the final Medicare local coverage determination (LCD) for its Prolaris test. The reimbursement, providing coverage to all low and very low-risk prostate cancer patients with life-expectancy of 10 years or more, has been in effect from Oct 15, 2015. Interestingly, the Prolaris test currently offers a reimbursement market of $200 million in the U.S. for Myriad. The company is also actively working to expand private payer coverage for Prolaris. We expect these study results to clear hurdles for Myriad in achieving reimbursement for all types of prostate cancer patients, which once done, will enable the company to rake in more profits from this test.
Zacks Rank
Myriad currently has a Zacks Rank #3 (Hold). Some better-ranked med-biomed/generic stocks are Arena Pharmaceuticals, Inc. ARNA, Atara Biotherapeutics, Inc. ATRA and Baxalta Incorporated BXLT. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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