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Arrayit Plans to File for FDA Clearance on Ovarian Cancer Dx in Early 2010

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This story originally ran on Dec. 17.

Microarray firm Arrayit said this week that it plans to file for regulatory clearance of its early-stage ovarian cancer diagnostic after Jan. 1, 2010, for possible commercial launch in the third quarter of next year.

In a statement, John Howell, CEO of Arrayit Diagnostics, said that the company will file for 510(k) clearance from the US Food and Drug Administration for its OvaDx, a protein microarray-based test, "shortly after the end of this year." The company plans to file for FDA approval of the test as an in vitro diagnostic multivariate index assay.

Arrayit Diagnostics, based in Houston, is a majority owned subsidiary of Arrayit Corp., headquartered in Sunnyvale, Calif.

The biomarkers comprising OvaDx were developed by researchers at Wayne State University. Earlier in the month, Arrayit said that it had licensed IP covering the biomarkers from the university. The agreement gives the company exclusive rights to develop and commercialize a test, OvaDx, using the biomarkers. The school and Arrayit are also collaborating on further researching and developing the test.

Howell said that barring unexpected delays in the approval process, the firm is optimistic that it will begin marketing OvaDx for research purposes late in the first quarter of 2010. Commercial launch of the test could happen as early as the third quarter.

He added that the test could reach $4 million to $5 million in sales next year, assuming its timeline for FDA clearance is achieved. OvaDx is expected to cost $350 per kit.

Beyond 2010, sales of the kits in the US, Japan, and Europe could reach 175 million kits per year with revenues reaching into the "hundreds of millions, and perhaps even billions, of dollars," Howell said.

Ovarian cancer presents with non-specific symptoms in the early stages of progression, and because there is no "adequate screening or diagnostic test for early stage detection," most cases of the disease are diagnosed in later stages when it has metastasized in other parts of the body, Arrayit said.

According to the National Cancer Institute, 21,550 women will be diagnosed with ovarian cancer in 2009, with 14,600 deaths.

In September, Vermillion received FDA 510(k) clearance for its OVA1 test, which can differentiate benign from malignant tumors [See PM 12/11/2009]. The company, which is currently awaiting a decision from US Bankruptcy Court in Delaware on its Chapter 11 reorganization plan, also had an early-stage ovarian cancer test in development.

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