Myriad Genetics Inc.
) 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.
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
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
ANI Pharmaceuticals, Inc.
Gilead Sciences Inc.
). All these stocks carry the same Zacks Rank as Myriad
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