John Howell, CEO of Arrayit Diagnostics, Inc., a majority-owned subsidiary of Arrayit Corporation (OTC Bulletin Board: ARYC), today formally commented on the anticipated timeline for commercialization of its microarray-based OvaDx(TM) Pre-Symptomatic Ovarian Cancer Blood Test, which is currently advancing through late-stage development - the rights to which have been assigned exclusively to the Company by Arrayit Corporation.
Howell stated, "In response to numerous inquiries received from the medical, research and investor communities following last week's exciting news announcements, we are pleased to confirm that Arrayit Diagnostics will file for Pre-Market Approval of our early stage ovarian cancer test as an 'In Vitro Diagnostic Multivariate Index Assay' shortly after the end of this year. Notwithstanding any unexpected delays with the 510(k) review and approval process, we are optimistic that we will be in position to begin marketing the test for research purposes late in the first quarter of 2010, followed by official commercial launch to the medical diagnostics industry as early as the third quarter of 2010."
Continuing, Howell added, "With plans to market the test at a cost of approximately $350 per test kit - and presuming we achieve our predetermined time-to-market objectives, we are confident that revenue of $4-$5 million is an attainable sales goal for 2010. Moreover, given that we estimate the total market for a viable early stage ovarian cancer screening test in the U.S., Japan and Europe could collectively represent use of up to 175 million kits per year; beyond 2010, annual revenues for Arrayit Diagnostics could ultimately reach into the hundreds of millions, and perhaps even billions, of dollars."
Ovarian cancer presents with largely non-specific symptoms during its initial stages of progression, however there is currently no adequate screening or diagnostic test for early stage detection. As a result, most ovarian cancers are diagnosed only when later stage symptoms manifest and the disease has metastasized to other parts of the body. Consequently, the five-year survival rate for late stage diagnosis is less than 20%, which compares to an approximate 90% survival rate if the disease is identified at the earliest stages. According to the National Cancer Institute, it is estimated that 21,550 women will be diagnosed with and 14,600 women will die of cancer of the ovary in 2009 in the United States. Moreover, based on rates from 2004-2006, 1.4% of women born today will be diagnosed with ovarian cancer at some point during their lifetime.
SOURCE Arrayit Diagnostics, Inc.