Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
Become a Member | Sign in
Home>News>This Article

American Journal of Obstetrics & Gynecology Publishes New Clinical Study of OVA1 Test

Published: Thursday, November 14, 2013
Last Updated: Thursday, November 14, 2013
Bookmark and Share
Significantly superior early-stage sensitivity shown versus CA125, modified ACOG guidelines or overall clinical assessment in premenopausal and postmenopausal women planning surgery.

A new study of OVA1® clinical performance in the presurgical detection of ovarian cancer, entitled "Clinical Performance of a Multivariate Index Assay For Detecting Early-Stage Ovarian Cancer," has been published in The American Journal of Obstetrics & Gynecology.

Led by Dr. Robert E. Bristow (UC Irvine Healthcare) and Dr. Frederick R. Ueland (U. Kentucky), the new analysis focuses on presurgical detection of early-stage ovarian cancer among 1,016 ovarian mass surgery patients in two previous pivotal trials conducted in 2007 and 2012.

The study compared OVA1 performance in early-stage ovarian cancer to commonly used cancer risk assessment protocols: overall clinical assessment, the CA125 biomarker or modified-American College of Obstetricians and Gynecologists (mod-ACOG) guidelines for evaluation of suspicious pelvic masses. Vermillion, Inc. has reported the findings at the American Association of Gynecologic Laparoscopists "42nd AAGL Global Congress on Minimally Invasive Gynecology."

"Early-stage ovarian cancer constitutes an important opportunity to improve survival and care for this most deadly gynecologic cancer," said Dr. Bristow. "However, as evidenced by recent studies, most ovarian cancer patients fail to be referred to the doctors and hospitals best equipped to treat them, resulting in unfortunate consequences.

"Our new study demonstrates OVA1's ability to detect the majority of all early-stage ovarian cancers prior to surgery and thereby aid in appropriately involving a gynecologic oncologist in their care. Even among premenopausal patients where primary ovarian cancer prevalence was only 15%, clinical assessment with OVA1 detected early-stage ovarian cancer with nearly 90% sensitivity. This is a very encouraging development for diagnosis and treatment of ovarian cancer."


As a benchmark of usual care, physicians were required to predict whether ovarian masses were malignant or benign following overall clinical assessment, which included physical examination and imaging, family history, and laboratory tests (including CA125, if used). Overall success of clinical assessment in predicting an early-stage malignancy (confirmed by pathology) was 68.6% (59 of 86 malignancies), while 31.4% were mistakenly predicted to be benign.

For stage I malignancies the percent detected fell to 63.9% (39/61), with 36.1% mistakenly predicted to be benign. Adding OVA1 to clinical assessment successfully identified 95.3% of early-stage cancers (82/86) and 93.4% of stage I malignancies (57/61) - a reduction in cancers missed of 85% (early-stage) and 82% (stage I), respectively over clinical assessment alone.

Among three risk-stratification methods compared directly for early-stage cancer detection, OVA1 showed the highest sensitivity (91.9%, or 79/86). OVA1 sensitivity was significantly higher than either benchmark method: sensitivity of the mod-ACOG guidelines was 76.7% (66/86) while CA125 sensitivity was 62.8% (54/86). The number of malignancies incorrectly stratified as low risk by CA125, mod-ACOG and OVA1 was 37.2%, 23.3% and 8.1%, respectively.

Early-stage cancer detection by OVA1 was 85.7% among premenopausal patients and 94.8% among postmenopausal patients. In contrast, CA125 alone correctly classified just 35.7% in premenopausal patients and 75.9% in postmenopausal patients. Used as intended together with clinical assessment, OVA1 sensitivity was 89.3% and 98.3% for pre- and post-menopausal early-stage cancer detection.

Dr. Donald Munroe, Vermillion's chief scientific officer and SVP of business development, commented: "Knowing the importance of referring early-stage ovarian cancer to gynecologic oncologists for optimal care, we are very encouraged by this latest clinical study. OVA1 significantly outperformed the three common risk assessment protocols in detecting early-stage cancers, which present the best opportunity for favorable outcomes or cure if appropriately handled. These results highlight the potential of OVA1 to replace the inferior off label use of CA125 and improve the presurgical management of ovarian cancer, which benefits patients, physicians and payers alike."

Further Information
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 2,600+ scientific posters on ePosters
  • More than 3,800+ 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 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

New Clinical Study on the Relationship Between Imaging and OVA1®
New analysis explores interactions between clinical risk factors used in pre-surgical assessment.
Friday, March 21, 2014
Vermillion Reports Fourth Quarter and Full Year 2013 Results
Company will next pursue a national price for its OVA1 test in 2014.
Saturday, March 08, 2014
Vermillion to Present at the 26th Annual ROTH Conference
Company to present at the conference on March 11, 2014.
Thursday, March 06, 2014
Vermillion to Present at Leerink Global Healthcare Conference
Conference to be held at the Waldorf Astoria Hotel from February 12-13, 2014.
Tuesday, February 04, 2014
Vermillion Completes $17.6 Million Warrant Exercise
Proceeds from the warrant exercise will be used to increase test sales for OVA1.
Friday, December 20, 2013
Vermillion Reports Results of 2013 Annual Meeting
Company has approved the reappointment of Peter S. Roddy.
Friday, December 20, 2013
Vermillion Appoints SVP of Sales and Marketing and Chief Commercial Officer
Appointment of Marian E. Sacco as senior vice president of sales and marketing.
Friday, December 20, 2013
Vermillion Board of Directors Elects James T. LaFrance as Chairman
LaFrance has been appointed a member of Company’s board on December 12, 2013.
Monday, December 16, 2013
Vermillion Reports Third Quarter 2013 Results
Company reports Q3 2013 financial results and key developments.
Friday, November 15, 2013
Vermillion Appoints Dr. Eric Varma to its Board of Directors
Dr. Varma is currently a partner at Oracle Investment Management.
Tuesday, September 17, 2013
Vermillion's OVA1 Receives New Statement by SGO
OVA1® has received new statement on clinical validation and medical use.
Tuesday, July 16, 2013
Vermillion Appoints President and Chief Executive Officer
Appointment of Thomas McLain effective March 18, 2013.
Thursday, July 04, 2013
Vermillion Appoints Bruce A. Huebner to Chairman of the Board
Shareholders to vote on approval of expanded stock incentive plan at upcoming annual meeting.
Friday, June 28, 2013
Vermillion Announces Closing of Equity Financing
Company to increase the number of directors of the Company from six to eight persons.
Thursday, May 16, 2013
Vermillion Supports First World Ovarian Cancer Day
Vermillion offers women new hope with OVA1, a FDA-cleared test designed to aid in the prediction of malignancy prior to surgery on an ovarian mass.
Thursday, May 16, 2013
Scientific News
The Age of Humans Controlling Microbes
Engineered bacteria could soon be used to detect environmental toxins, treat diseases, and sustainably produce chemicals and fuels.
Predictive Model for Breast Cancer Progression
Biomedical engineers have demonstrated a proof-of-principle technique that could give women and their oncologists more personalized information to help them choose options for treating breast cancer.
Are Changes to Current Colorectal Cancer Screening Guidelines Required?
Editorial suggests more research is needed to pinpoint age to end aggressive screening.
New Molecular Marker for Killer Cells
Cell marker enables prognosis about the course of infections.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
New Test Detects All Viruses
A new test detects virtually any virus that infects people and animals, according to research at Washington University School of Medicine in St. Louis, where the technology was developed.
Scientists Create World’s Largest Catalog of Human Genomic Variation
An international team of scientists from the 1000 Genomes Project Consortium has created the world’s largest catalog of genomic differences among humans, providing researchers with powerful clues to help them establish why some people are susceptible to various diseases.
Chip-Based Technology Enables Reliable Direct Detection of Ebola Virus
Hybrid device integrates a microfluidic chip for sample preparation and an optofluidic chip for optical detection of individual molecules of viral RNA.
Diagnostics Breakthrough Brings Viral Sequencing to Doctors’ Toolkit
New screening tool produces up to 10,000-fold improvement in viral matches compared with traditional high-throughput methods.
New Cell Type May Help Explain Dangerous Food Allergies
Researchers have discovered a new cell type that appears to drive life-threatening food allergies and may help explain why some people get severe allergic reactions and others do not.
Skyscraper Banner

Skyscraper Banner
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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos