John Howell, CEO of Arrayit Diagnostics Inc., a majority-owned subsidiary of Arrayit Corp formally commented on the anticipated timeline for commercialization of its microarray-based OvaDx™ 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."
Source: Arrayit Corp
