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_______________________________________________________________ Report Information from ProQuest03 October 2015 06:53_______________________________________________________________

Document 1 of 1 Vermillion, Inc.; American Journal of Obstetrics &Gynecology Publishes New Clinical Study on theRelationship Between Imaging and OVA1(R) in Assessing Risk of Ovarian Cancer ProQuest document link Abstract: Dr. Scott Goodrich of the University of Kentucky led the study in collaboration with colleagues Drs.[Fred Ueland, M.D.] and Rachel Ware Miller. The findings are the third in a series of subset analyses of dataobtained from 1,100 ovarian mass surgery patients in two previous pivotal trials of OVA1 clinical performance,conducted in 2007 and 2012. The authors compared the performance of each imaging method alone, to theperformance of OVA1 alone (for risk stratification), as well as in combination with OVA1. In addition, the authorspresented logistic regression models showing how menopausal status, high- or low-risk imaging and OVA1score interact in the assessment of ovarian cancer risk. The researchers concluded that "serum biomarkers andimaging are a complementary set of clinical tools and that when the [OVA1] score is further stratified by imagingrisk and menopausal status, there is a better understanding of the clinical risk of ovarian malignancy." Full text: 2014 APR 5 (NewsRx) -- By a News Reporter-Staff News Editor at Cancer Law Weekly -- (Nasdaq:VRML) -- A new study of OVA1(R) clinical performance, titled "The Effect of Ovarian Imaging on the ClinicalInterpretation of a Multivariate Index Assay," has been released as an online advance publication of TheAmerican Journal of Obstetrics &Gynecology.[1] The study examines the relationship between two commonlyused imaging methods - ultrasound (US) and computed tomography (CT) - and the OVA1 test result, inassessing the risk of ovarian cancer among patients planning surgery for an ovarian mass. OVA1 is an FDA-cleared blood test that measures the levels of five proteins and then uses a proprietary algorithm and softwarecalled OvaCalc(R) to calculate a single risk score. "This new study advances our understanding of how OVA1 and imaging work together in the pre-surgicalassessment of ovarian cancer risk," said study co-author Fred Ueland, M.D., associate professor of gynecologiconcology at the University of Kentucky's Markey Cancer Center. "This is important for two reasons. First, addingOVA1 reduced the number of ovarian cancers missed with imaging alone, by 85 to 90 percent. Recentpublications have reinforced that the first surgery is an important opportunity to improve ovarian cancer survivalby ensuring that cancers are detected earlier and that they are operated on by the most experienced specialists.Second, this study provides new evidence of how menopausal status, imaging and OVA1 score mayinterrelate." Dr. Scott Goodrich of the University of Kentucky led the study in collaboration with colleagues Drs. Fred Uelandand Rachel Ware Miller. The findings are the third in a series of subset analyses of data obtained from 1,100ovarian mass surgery patients in two previous pivotal trials of OVA1 clinical performance, conducted in 2007and 2012. The authors compared the performance of each imaging method alone, to the performance of OVA1alone (for risk stratification), as well as in combination with OVA1. In addition, the authors presented logisticregression models showing how menopausal status, high- or low-risk imaging and OVA1 score interact in theassessment of ovarian cancer risk. The researchers concluded that "serum biomarkers and imaging are acomplementary set of clinical tools and that when the [OVA1] score is further stratified by imaging risk andmenopausal status, there is a better understanding of the clinical risk of ovarian malignancy." This latest study brings the number of full research articles on OVA1 clinical performance to a total of five peer-reviewed publications. Together, these data provide strong, prospective clinical evidence that OVA1 improvesthe pre-surgical detection of ovarian cancer, regardless of stage or subtype, in patients undergoing surgery for asuspicious ovarian mass. "The sensitivity of OVA1 is critical to the detection of ovarian malignancy, pre-surgical risk assessment anddetermining whether a woman may benefit from consultation with a gynecologic oncologist prior to surgery,"

said Donald Munroe, chief scientific officer and SVP of business development at Vermillion. "Vermillion iscommitted to fully developing this clinical evidence, together with future studies on how OVA1 may impact theefficiency and quality of care for women facing ovarian cancer, the deadliest of all gynecologic malignancies." More than 22,000 women are diagnosed with ovarian cancer in the United States annually, and more than12,000 die each year.[2] Leading medical associations, including the American College of Obstetrics andGynecology (ACOG), recommend that women with suspected ovarian cancer be referred to a gynecologiconcologist for surgery for the best potential outcomes. However, only an estimated one-third of women whohave a malignant tumor are operated on by a gynecologic oncologist for the initial removal of cancer.[3] This publication, "The Effect of Ovarian Imaging on the Clinical Interpretation of a Multivariate Index Assay," isalso co-authored by Dr. Robert Bristow (UC Irvine, Calif.), Dr. Joseph Santoso (The West Clinic, Tenn.), Dr.Zhen Zhang (Johns Hopkins Medical Institute) and Alan Smith (Applied Clinical Intelligence). It will be publishedin print in the 2(nd) quarter of 2014 in the American Journal of Obstetrics &Gynecology. Keywords for this news article include: Cancer, Surgery, Oncology, Vermillion Inc. Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014,NewsRx LLC People: Fred Ueland, MD Publication title: Cancer Law Weekly First page: 166 Publication year: 2014 Publication date: Apr 5, 2014 Year: 2014 Publisher: NewsRx Place of publication: Atlanta Country of publication: United States Publication subject: Medical Sciences--Oncology ISSN: 15515281 Source type: Trade Journals Language of publication: English Document type: Expanded Reporting ProQuest document ID: 1510129205 Document URL: http://search.proquest.com/docview/1510129205?accountid=25704 Copyright: Copyright 2014, Cancer Law Weekly via NewsRx.com Last updated: 2014-03-26 Database: ProQuest Health Management

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