Yesterday, Arrayit Diagnostics, a majority-owned subsidiary of Arrayit Corporation released its anticipated timeline for commercialization of its microarray-based OvaDx(TM) Pre-Symptomatic Ovarian Cancer Blood Test. CEO John Howell formally commented on the time line and the blood test, which is currently in late-stage development. The rights to OvaDx™ 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.”
He continued, “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.”
According to the National Cancer Institute, ovarian cancer will affect over 21,000 women in the United States this year. During its initial stages of progression, ovarian cancer shows non-specific symptoms; however, no adequate screening or diagnostic test for early stage detection currently exists on the market. Consequently, most ovarian cancers are diagnosed only when later stage symptoms manifest, lowering the five-year survival rate for late stage diagnosis to less than 20%. Comparatively, early stage identification is approximately 90% survival rate if the disease is identified at the earliest stages. Arrayit Diagnostics hopes that its OvaDx™ product will answer the call for necessary early-stage testing.
Regarding the company’s marketing strategy, 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.”