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Myriad Genetics Posts Positive Data on Oncology Tests

Myriad Genetics Inc.MYGN recently released positive data from three new studies involving its myChoice homologous recombination deficiency (HRD) and Tumor BRACAnalysis CDx companion diagnostic tests and Prolaris Prostate cancer test. The company will present these results during the 40 th European Society for Medical Oncology (ESMO) meeting to be held from Sep 25 to Sep 29 in Vienna, Austria.

In the first clinical trial, named NOVA, Myriad showed that myChoice test can detect 100% of patients having a germline BRCA mutation, responsible for increasing the risk of breast and ovarian cancers in women. More specifically, myChoice HRD test exhibited its ability to define the HRD positive population in ovarian cancer patients more clearly than traditional tests. Management believes that this will allow myChoice test to more effectively identify patients, who may be treated with DNA damaging agents, such as platinum drugs and PARP inhibitors.

In the second study, Myriad evaluated the ability of its Tumor BRACAnalysis CDx test to detect the presence of germline BRCA1/2 mutations in patients suffering from high-grade serous ovarian cancer. Evidently, in all the cases, the test diagnosed correctly, representing 100% sensitivity. The study result also demonstrated the ability of the test in identifying de novo somatic mutations within tumor cells, which standard germline testing alone fails to do.

In the third clinical trial named EMPATHY-P study, Myriad compared the ability of its Prolaris test to standard clinical pathology methods in determining the aggressiveness of prostate cancer in 502 patients. It was found that the Prolaris test score indicated 24% of the patients had less aggressive prostate cancer, while 30% had more aggressive disease compared with standard clinical pathology measurements. Management believes that this result demonstrated the advantage of using the Prolaris test score in estimating personalized risk assessment for men with localized prostate cancer and identifying candidates for active surveillance.

Historically, Myriad has been one of the largest specialty molecular diagnostic providers in the world, with a global market worth over $25 billion. Recently, the company set a goal of becoming the global leader in companion diagnostics for DNA damaging agents. We believe that the first two study results reflect substantial progress on Myriad's part toward achieving this goal.

On the other hand, with a global market worth $1.5 billion (annually) for its Prolaris Prostate cancer test, the positive EMPATHY-P data has been revealed at a high time. In Aug 2015, the company received the final Medicare local coverage determination (LCD) for its Prolaris test for low and very low-risk prostate cancer patients, expected to come into effect from Oct 2015. As Myriad is currently pursuing broader indications for Prolaris for all risk category patients and expanded private payer coverage, undoubtedly the EMPATHY-P data will act as a positive catalyst to receive the same.

Thus, Myriad gained a competitive leverage with the recent test results in the molecular diagnostics market, which is expected to reach $8 billion by 2020. We expect demand for these tests to rise substantially, once the results are formally presented, in turn boosting profit for Myriad.

Currently, Myriad carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the med-biomed/generic space are Medivation, Inc. MDVN , Gilead Sciences Inc. GILD and Neogenomics Inc. NEO . All the three stocks sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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