Arrayit Corporation (ARYC) leads and empowers the genetic, research, pharmaceutical, and diagnostic communities through the discovery, development and manufacture of proprietary life science technologies and consumables for disease prevention, treatment and cure. - Powerful Science for Life
Arrayit Diagnostics to Bring First Pre-Symptomatic Ovarian Cancer Blood Test to Multi-Billion Dollar Diagnostic Market in 2010
Source: Arrayit Diagnostics, Inc.
On 7:00 am EST, Thursday December 17, 2009
HOUSTON, Dec. 17 /PRNewswire-FirstCall/ -- 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 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.
About Arrayit Corporation
Arrayit Corporation, headquartered in Sunnyvale, California, leads and empowers the genetic, research, pharmaceutical and diagnostic communities through the discovery, development and manufacture of proprietary life science technologies and consumables for disease prevention, treatment and cure. It now offers over 650 products to a customer base of more than 10,000 laboratories worldwide, including almost every major university, pharmaceutical and biotechnology company, major agricultural and chemical companies, government agencies, national research foundations and many private sector enterprises. Please visit http://www.arrayit.com/ for more information.
About Arrayit Diagnostics, Inc.
Houston-based Arrayit Diagnostics, Inc., a majority-owned subsidiary of Arrayit Corporation, is actively engaged in developing and commercializing a series of proprietary microarray-based diagnostic tests that provide for early detection of cancers, neurodegenerative diseases and other chronic and severe disease states.
Safe Harbor Statement
Except for historical information contained herein, statements made in this release that constitute forward-looking statements are based on currently available information, involve certain risks and uncertainties and the Company assumes no responsibility to update any such forward-looking statement. The following factors, among others, may cause actual results to differ materially from the results suggested in the forward-looking statements. Risks that may result from changes in the Company's business operations; our ability to keep pace with technological advances; significant competition in the biomedical business; our relationships with key suppliers and customers; quality and consumer acceptance of newly introduced products; market volatility; non-availability of product; excess inventory; price and product competition; new product introductions, the outcome of our legal disputes; the possibility that the review of our prior filings by the SEC may result in changes to our financial statements; and the possibility that stockholders or regulatory authorities may initiate proceedings against Arrayit and/or our officers and directors as a result of any restatements. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company's Form 10-K/A for the fiscal year ended December 31, 2008 and Form 10-Q/A for the fiscal first quarter ended March 31, 2009, Form 10-Q/A for the fiscal second quarter ended June 30, 2009 and Form 10-Q for the fiscal third quarter ended September 30, 2009.
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