Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

New Clinical Study on the Relationship Between Imaging and OVA1®

Published: Friday, March 21, 2014
Last Updated: Friday, March 21, 2014
Bookmark and Share
New analysis explores interactions between clinical risk factors used in pre-surgical assessment.

A new study of OVA1® clinical performance, titled "The Effect of Ovarian Imaging on the Clinical Interpretation of a Multivariate Index Assay," has been released as an online advance publication of The American Journal of Obstetrics & Gynecology.

The study examines the relationship between two commonly used imaging methods - ultrasound (US) and computed tomography (CT) - and the OVA1 test result, in assessing 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 software called OvaCalc® to calculate a single risk score.

"This new study advances our understanding of how OVA1 and imaging work together in the pre-surgical assessment of ovarian cancer risk," said study co-author Fred Ueland, M.D., associate professor of gynecologic oncology at the University of Kentucky's Markey Cancer Center. "This is important for two reasons. First, adding OVA1 reduced the number of ovarian cancers missed with imaging alone, by 85 to 90 percent. Recent publications have reinforced that the first surgery is an important opportunity to improve ovarian cancer survival by 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 may interrelate."

Dr. Scott Goodrich of the University of Kentucky led the study in collaboration with colleagues Drs. Fred Ueland and Rachel Ware Miller. The findings are the third in a series of subset analyses of data obtained 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 the performance of OVA1 alone (for risk stratification), as well as in combination with OVA1. In addition, the authors presented logistic regression models showing how menopausal status, high- or low-risk imaging and OVA1 score interact in the assessment of ovarian cancer risk.

The researchers concluded that "serum biomarkers and imaging are a complementary set of clinical tools and that when the [OVA1] score is further stratified by imaging risk and menopausal 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 improves the pre-surgical detection of ovarian cancer, regardless of stage or subtype, in patients undergoing surgery for a suspicious ovarian mass.

"The sensitivity of OVA1 is critical to the detection of ovarian malignancy, pre-surgical risk assessment and determining 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 is committed to fully developing this clinical evidence, together with future studies on how OVA1 may impact the efficiency 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 than 12,000 die each year. Leading medical associations, including the American College of Obstetrics and Gynecology (ACOG), recommend that women with suspected ovarian cancer be referred to a gynecologic oncologist for surgery for the best potential outcomes. However, only an estimated one-third of women who have a malignant tumor are operated on by a gynecologic oncologist for the initial removal of cancer.

This publication, "The Effect of Ovarian Imaging on the Clinical Interpretation of a Multivariate Index Assay," is also 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 published in print in the 2nd quarter of 2014 in the American Journal of Obstetrics & Gynecology.

METHODS AND FINDINGS

The study evaluated a combined population from the OVA1 FDA registration and OVA500 confirmatory trials, for a total of 1,024 evaluable patients 18 years or older, and planning surgery for ovarian masses. To assess the value of OVA1 added to routine assessment, enrolling physicians were allowed to use their preferred method of imaging.

Since OVA1 is not indicated for women with clinical evidence of advanced ovarian cancer, ascites and metastatic implants, the small number of patients with these indicators was excluded from the analysis, leaving a total of 721 evaluable subjects who were imaged with ultrasound (US), and 313 with CT scanning.

Patients imaged with MRI were also excluded from the analysis due to low numbers (N=43) confounding statistical interpretation. Overall clinical performance of US, CT and OVA1 is presented in the Data Summary table below, along with the performance when OVA1 is combined with imaging as a logical "OR" function (along with the performance of OVA1 in combination with imaging as a logical "OR" function), per the product's risk stratification protocol.

In addition, this combination of ultrasound and OVA1 detected 95 percent of early-stage ovarian cancers, consistent with previous reports of the combined study population.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Vermillion's OVA1 Receives New Statement by SGO
OVA1® has received new statement on clinical validation and medical use.
Tuesday, July 16, 2013
Scientific News
AACR 2016: Cancer Immunotherapy and Beyond
At this year's meeting there was a palpable buzz around subjects ranging from microbiomics to the tumor microenvironment and cancer vaccines, big data to in vitro and in vivo modeling and drug delivery (to name just a few).
New Database for Sharing MS Clinical Trial Data
A new database containing nearly 2500 patient records from the placebo arms of nine multiple sclerosis (MS) clinical trials is now available for research by qualified investigators.
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
Treatment of Common Prostate Cancer
Researchers at UTSW have found that the prostate cancer treatments suppress immune response and may promote relapse.
Cancer Drug Could Treat Blood Vessel Deformities
A drug currently being trialled in cancer patients could also be used to treat an often incurable condition that can cause painful blood vessel overgrowths inside the skin.
Structure of Crucial Enzyme Identified
Researchers at UTSW have determined the atomic structure of an enzyme that plays an essential role in cell division and better treatment of cancer.
New Immunotherapy Trial for Type 1 Diabetes
The search for a treatment for Type 1 diabetes (T1D) - which affects over 400,000 people in the UK – will be stepped up with the start of a new phase one clinical trial at Guy’s Hospital in London.
Recruitment of First Patient in Clinical Study
Company has announced recruitment of first patient in clinical study assessing Visco-ease with Beatson Cancer Centre for the treatment of RIX.
Fighting Prostate Cancer
Identifying the most promising compounds which can be used as medications for prostate cancer.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!