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Vermillion Announces Patent for AD Biomarkers, Second Peer-Reviewed Paper on OVA1

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Vermillion said this week it has received a notice of allowance from the US Patent and Trademark Office for a patent covering the use of the proteins saposin D and Fam3c as well as combinations that include these proteins as biomarkers for Alzheimer's disease.

The company received notice of allowance for another US patent for Alzheimer's in June 2010, that one covering cover biomarker combinations for the diagnosis and management of Alzheimer's disease and their measurement by methods including mass spectrometry and immunoassay (PM 07/02/2010).

Despite the patents, Alzheimer's is not currently a focus of research at Vermillion. In an August 2010 earnings call, Vermillion's chief science officer Eric Fung noted that the June patent reflected work done several years ago that was not part of an active program (PM 08/13/2010).

Also this week the company announced that a second peer-reviewed paper on its ovarian cancer diagnostic OVA1 has been published in the online edition of Obstetrics & Gynecology. The first paper, published two weeks ago in the same journal, found that replacing CA125 with OVA1 increased the sensitivity of the American College of Obstetricians and Gynecologists referral guidelines from 77 percent to 94 percent for women presenting with pelvic masses while dropping specificity from 68 percent to 35 percent (PM 05/13/2011). The CA125 test is currently the standard protein-based diagnostic for ovarian cancer.

This second paper presented similar results, finding that replacing CA125 with OVA1 increased the sensitivity of the ACOG ovarian cancer detection guidelines from 68 percent to 98 percent in early-stage epithelial ovarian cancer and from 36 percent to 93 percent in premenopausal early-stage cancers. Specificity was again decreased by replacing CA125 with OVA1, however, with OVA1 resulting in roughly double the number of false positives.

As the company has noted, peer-reviewed publications are considered key to increasing adoption of the test among physicians. However, its low specificity may make some doctors reluctant to use it.

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