Myriad Genetics Inc. (MYGN) recently presented favorable data from a clinical validation study of Prolaris at the 2014 annual meeting of American Urological Association. The company claims this validation study to be the largest to date of any gene-based prognostic test in prostate cancer patients who have been diagnosed through needle biopsy.

Per the findings of this data, while the aggressiveness of newly diagnosed prostate cancer is difficult to predict, the Prolaris test accurately measures mortality risk in prostate cancer patients. It differentiates newly diagnosed patients with lower risk from those who are likely to die due to prostate cancer within a span of 10 years. Thus Prolaris, as an advanced molecular diagnostic test, emerges as a much stronger indicator of clinical outcomes than standard clinical tools like Gleason Score or PSA, when it comes to predicting cancer-specific death and metastases in prostate cancer patients.

Data showed that for one unit increase in the Prolaris score, the risk of death from prostate cancer approximately gets doubled. The results also establish the superiority of the Prolaris test over Gleason score, PSA, age, clinical stage or extent of disease individually and almost doubles the total predictive information when they are combined.

Furthermore, in a second study the results showed that there was no difference in biochemical recurrence (BCR) based on an assessment using the Gleason Score alone. However, the results underscore that genomic tests must be correlated with meaningful oncologic endpoints, rather than endpoints like upgrading. According to the company, these findings should facilitate initial decisions on the most effective treatment for each patient based on his personal risk of disease progression.

A third study presented at the American Urological Association proved that the Prolaris test is the strongest predictor of metastatic disease compared to all other tested clinical variables. Patients with a high Prolaris score have more than a six-fold greater risk of developing metastases as against those with a low score. Thus this test is extremely significant in determining patients at high risk and in choosing appropriate medical care as per their risk profiles.

Our Take

We are encouraged by the company’s focus on Prolaris. Positive data from the abovementioned studies should further support reimbursement efforts. Recently the company submitted the clinical utility study for Prolaris to Medicare. The company expects to establish reimbursement for Prolaris in the second half of fiscal 2014 after which it plans to launch this test on a more extensive scale.

Meanwhile, Myriad is progressing well on its commercialization efforts and is strengthening its Prolaris sales team with focus on the highly untapped $1.2 billion market at present. Higher demand for the company’s offerings led to an upward revision in Myriad’s guidance for fiscal 2014.

Myriad Genetics currently holds a Zacks Rank #1 (Strong Buy). Some other stocks worth considering in the biomedical industry include ANI Pharmaceuticals, Inc. (ANIP), Illumina Inc. (ILMN), and Gilead Sciences Inc. (GILD). All these stocks carry the same Zacks Rank as Myriad Genetics.

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