Keeping in line with its strategy to launch its prostate cancer test by the first half of 2013, Genomic Health, Inc. (GHDX - Analyst Report) set a presentation at the American Urological Association ("AUA"), scheduled on May 8, 2013. Here the company will demonstrate complete results from the positive clinical validation study of its biopsy-based Oncotype DX prostate cancer test.
The company stated that the presentation will include the results of previously conducted development studies led by Cleveland Clinic based on 700 patients and 700 candidate genes, which were needed to select the required genes for this test. The company is currently making efforts to launch this Oncotype DX Genomic Prostate Score (GPS) by the end of the second quarter of 2013.
We note that, earlier in September, the company announced positive results from a large clinical validation study of GPS. The study, which was performed in collaboration with prostate cancer researchers of the University of California, demonstrated that the multi-gene OncotypeDX GPS assessed in prostate needle biopsy tumor tissue is a predictor of adverse pathology for patients with early-stage prostate cancer. The study supported the results of six earlier feasibility and development studies performed in collaboration with the Cleveland Clinic.
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. According to the 2012 data, 900,000 people worldwide were diagnosed with prostate cancer and based upon the results of prostate-specific antigen (PSA) testing, biopsies were performed on over one million men in the U.S., out of which 240,000 were diagnosed with prostate cancer.
As a global cancer company, Genomic Health is focused on the development and commercialization of genomic-based clinical tests for cancer diagnosis that enables physicians to make customized treatment decisions. 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 the future tests.
Genomic Health carries a Zacks Rank #3 (Hold). Other medical device stocks worth a look are Given Imaging , Medical Action Industries Inc. and Cytokinetics Incorporated (CYTK - Snapshot Report) . All the stocks carry a Zacks Rank #1 (Strong Buy).