Presymptomatic Screening Test for Ovarian Cancer Under Development

A breakthrough in ovarian cancer screening utilizing a microarray-based diagnostic test has been achieved that will detect whether a patient is presymptomatic for this silent killer.

Until now, there has been no effective screening test available to detect the presymptomatic presence of ovarian cancer. However, On December 9, 2009, Arrayit Corp. (Sunnyvale, CA, USA), a leading manufacturer of products and services for disease prevention, treatment, and cure, announced that Arrayit's advanced ovarian cancer screening test, OvaDx, would be available very soon.

Researchers at a major cancer research institute have worked for six years to identify more than 100 biomarkers unique to ovarian cancer. The proteomic markers were finally identified using an innovative and patented microarray platform created by Arrayit. A noninvasive screening test can be performed via a simple blood test that can be conducted during annual physical exams. The test will soon be submitted to the U.S. Food and Drug Administration (FDA) for approval, and because it is an in vitro diagnostic multivariate index assay, prompt approval is anticipated.

To date, screening tests could only detect ovarian cancer when the disease is symptomatic, meaning the disease has progressed to stage 3 or 4. Unfortunately, at this late stage of detection the cancer most certainly has metastasized and spread beyond the ovary, which proves fatal for 75% of the women diagnosed.

Clinicians report that the primary reasons for such a high fatality rate are that there are no discernable early symptoms, and there has not been an effective early detection test available. The American Cancer Society (Atlanta, GA, USA) estimates that 90% of woman diagnosed with ovarian cancer could survive with early detection. Currently only 20% of women diagnosed are in the early stages.

The early detection of ovarian cancer holds great potential to profoundly affect the quality of life of ovarian cancer victims and shift costs from treatment to detection ensuring survivability for a larger population. Upon FDA approval, OvaDx will be marketed and sold by Arrayit's subsidiary, Arrayit Diagnostics, Inc., based in Houston, TX, USA, under a licensing agreement.

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