Currently advancing through late-stage development
Arrayit Diagnostics, a majority-owned subsidiary of Arrayit Corporation, has reported its anticipated timeline for commercialisation of its microarray-based OvaDx pre-symptomatic ovarian cancer blood test.
It is currently advancing through late-stage development and the rights to which have been assigned exclusively to the company by Arrayit Corporation.
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 US. 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, said the company.
John Howell, CEO of Arrayit Diagnostics, said: “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.
“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-$5m 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 US, Japan and Europe could collectively represent use of up to 175m kits per year, beyond 2010, annual revenues for Arrayit Diagnostics could ultimately reach into the hundreds of millions, and perhaps even billions, of dollars.”