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Much Awaited Test Launch by Genomic

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Recently, Genomic Health Inc. (GHDX - Free Report) made available its lead pipeline candidate Oncotype DX prostate cancer test to physicians and their patients. This comes as a major boost to the company as its effort to launch the test by the second quarter of 2013 (ending Jun 30, 2013) paid off.  

The launch of the prostate cancer test, developed in collaboration with University of California, San Francisco (UCSF) and Cleveland Clinic was based on the disclosure of positive clinical validation study at the 2013 American Urological Association (AUA) Annual Meeting in San Diego. Besides clinical elements such as PSA and biopsy Gleason Score, the results from the clinical validation study affirm that Genomic’s test can predict the aggressiveness of the cancer in patients.

As a prognostic tool to assess prostate cancer aggressiveness, Genomic’s Oncotype DX prostate cancer test estimates the level of expression of 17 genes across four biological pathways. The outcome of the tests is reported as Genomic Prostate Score (GPS), ranging from 0 to 100. In conjunction with other clinical factors, the GPS can estimate the patient’s risk before the treatment intervention. Further, the outcome of the test can improve standards of care by helping patients to choose the right treatment on the basis of individual risk assessment.

Also, the Oncotype DX prostate cancer test is the most innovative multi-gene test to oversee treatment selection using the prostate needle biopsy sample taken before the prostate is removed. This helps low-risk patients erode invasive treatments like radical prostatectomy or radiation. Additionally, most patients can evade unnecessary treatment and its potential side effects and consider active surveillance treatment plan with routine check up.

Our Take

We are encouraged by the timely launch of Genomic’s Oncotype DX prostate cancer test. The commercialization of the prostate cancer test will allow the company to serve a global market size of more than $1.6 billion.

We believe that with the commercial launch, GPS will create a sizable impact on the market as prostate cancer is among the most common types of cancers. The prostate cancer test is expected to be a major revenue driver for Genomic, which heavily relies on its Oncotype DX breast cancer test. The company strongly believes that the launch of the prostate cancer test will further strengthen its advanced next generation sequencing (NGS) platform and accelerate the development of future tests.

The stock carries a Zacks Rank #3 (Hold). While we have a neutral stance on Genomic, other players such as Alkermes plc (ALKS - Free Report) , carrying Zacks Rank #1 (Strong Buy) and Myriad Genetics Inc. (MYGN - Free Report) , and Illumina Inc. (ILMN - Free Report) carrying Zacks Rank #2 (Buy) are expected to do well.

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