Shares of Myriad Genetics, Inc. (MYGN) rose 3.4% to eventually close at $38.10 on Friday, subsequent to the company's announcement of the receipt of CE Mark for its eminent companion diagnostic test – Tumor BracAnalysis CDx, in Europe. Subsequent to the receipt of this approval, Myriad launched this test as a companion diagnostic for PARP Inhibitors in Europe.
Myriad's Tumor BracAnalysis CDx is a highly accurate molecular companion diagnostic test that can detect the presence of both hereditary as well as tumor-based cancer-causing mutations in the BRCA1 and BRCA2 genes, through the examination of a patient's blood sample.
With this announcement, Myriad's Tumor BracAnalysis CDx has become the first ever tumor-based companion diagnostic test to receive the CE Mark. Notably, the test can determine patients who are suitable to receive AstraZeneca's (AZN) FDA-cleared ovarian cancer drug – LynParza, which is a poly ADP-ribose polymerase (PARP) inhibitor.
It is crucial to differentiate between ovarian cancer patients having hereditary and tumor-based BRCA mutations, so that appropriate measures of treatment can be undertaken.
At the moment, Myriad's Tumor BracAnalysis CDx is the most potent option to differentiate among ovarian cancer patients as it can identify both hereditary and tumor-based BRCA mutations.
Management at Myriad believes the CE Mark represents a significant milestone for the company. The approval opens up new avenues for a validated tumor-based diagnostic test that can be used as a companion diagnostic with Lynparza and future PARP inhibitors in Europe.
At the European Society of Medical Oncology meeting, held in Sep 2014, data presented by Myriad showed that its tumor BracAnalysis CDx can identify approximately 44% more ovarian cancer patients who are likely to respond to Lynparza than conventional hereditary BRCA testing. We believe such prospects significantly enhance the market potential for the BracAnalysis CDx test.
Management further believes Lynparza's clearance in Europe will be a major catalyst for Myriad's international revenue growth. On approval, Lynparza will represent a $100 million per year companion diagnostic testing opportunity in Europe. This naturally translates into potential growth opportunity for Myriad's BracAnalysis CDx in Europe.
It is worth mentioning in this regard that the European Medicines Agency (EMA) has approved Lynparza as a monotherapy for treating ovarian cancer patients. However, at the moment, the European Commission is investigating the full potential of this drug; hence the final approval is still pending.
Consequently, management at Myriad expects to receive a revenue benefit in the second half of fiscal 2015 from the Tumor BracAnalysis CDx test.
Currently, Myriad is engaged in active partnership with leading pharmaceutical companies to develop Tumor BracAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other novel chemotherapeutic agents.
Evidently, the company is making progress with its pharmaceutical partners in the U.S. It announced new commercial collaboration with AbbVie Inc. (ABBV) in Nov 2014 for Tumor BracAnalysis CDx.
Currently, Myriad Genetics, AstraZeneca and AbbVie hold a Zacks Rank #2 (Buy). Another better-ranked stock in the med-biomed/generic industry is Affymetrix Inc. (AFFX), which holds a Zacks Rank #1 (Strong Buy).
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