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

Vermillion's OVA1 Receives New Statement by SGO

Published: Tuesday, July 16, 2013
Last Updated: Tuesday, July 16, 2013
Bookmark and Share
OVA1® has received new statement on clinical validation and medical use.

Vermillion, Inc.'s OVA1® has received a new statement on clinical validation and medical use issued by the Society of Gynecologic Oncology (SGO).

Citing peer-reviewed publications from two pivotal clinical studies of OVA1® versus standard of care, the statement also referred to OVA1 use within the context of the American Congress of Obstetricians and Gynecologists' (ACOG) 2011 Committee Opinion, "The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer."

This guideline, updated from a previous version issued in 2002, covers the management of adnexal masses, including serum markers for ovarian cancer detection.

SGO stated: "…The test may be useful in identifying women who should be referred to a gynecologic oncologist. Recent data have suggested that the OVA1 test along with physician clinical assessment may improve detection rates of malignancies among women with pelvic masses planning surgery."

The complete statement on OVA1 clinical validation and medical use is available on SGO's website.

This second SGO statement on OVA1 since its FDA clearance in 2009 represents another significant step toward acceptance of OVA1 as the standard of care for pre-surgically evaluating the risk of ovarian cancer in women with adnexal masses.

The new statement does two things:

• Refers to publications of OVA1's two pivotal clinical studies, comprised of the original FDA validation study published in June 2011 and the OVA500 "intended use" study published in 2013. Together, this offers an extensive, peer-reviewed proof source for physicians and payers to assess OVA1's clinical performance and comparative medical benefits versus today's standard of care.
• Places OVA1 use in the context of current ACOG practice guidelines, where CA125 has been used off-label for many years to predict malignancy before surgery, although with inferior performance.

Two key developments in 2013 underlined the timeliness of this updated statement by SGO. The first was the publication of the company's second pivotal clinical study, OVA500, in the February edition of Gynecologic Oncology.

OVA500 was led by Dr. Robert E. Bristow, director of Gynecologic Oncology Services at UC Irvine Healthcare in Orange, California.

The second development was a study in the June edition of the journal Obstetrics and Gynecology, which made the front page of the New York Times under the headline, "Widespread Flaws Found in Ovarian Cancer Treatment."

This study, also led by Dr. Bristow, reported that most women with ovarian cancer "are treated by doctors and hospitals that see few cases of the disease and lack expertise in the complex surgery and chemotherapy that can prolong life."

Dr. Bristow said, "If we could just make sure that women get to the people who are trained to take care of them, the impact would be much greater than that of any new chemotherapy drug or biological agent."

After reviewing the SGO statement, Dr. Hector Chapa, MD, FACOG and medical director of the Women's Specialty Center in Dallas observed: "This new statement by SGO affirms the important role which OVA1 should play in the workup of patients with an adnexal mass, and particularly before surgery is undertaken by a surgeon uncertified in the gynecologic oncology specialty. This is important because a large number of malignancies are discovered after a surgery where the mass was thought to be benign after negative CA125 or physical examination. Now, we await an updated guideline from ACOG, replacing CA125 with the greatly improved sensitivity and negative predictive value of OVA1. After all, ACOG first mentioned excitement about OVA1 in the Gynecology Practice bulletin of March 2011, prior to publication of the two clinical studies cited by SGO. I believe the new SGO statement is a very positive advance for patients, physicians and health insurance companies alike."

Vermillion President and CEO Thomas McLain commented: "We highly value the support SGO has provided in two statements about the benefits of OVA1 testing. For patients with ovarian cancer, Vermillion understands that timely access to a trained gynecologic oncology specialist is critical. Optimal treatment, survival and post-surgical outcomes all depend upon improvements in the detection of ovarian malignancies of all types, and as early as possible. OVA1 directly addresses the difficult challenge of identifying the more than 22,000 ovarian malignancies that are associated with 300,000 gynecologic surgeries performed every year. We look forward to supporting ACOG's review of this new clinical data and the SGO statement. We are committed to working to improve the standard of care for all gynecologic surgery patients at risk of ovarian cancer."


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 4,000+ scientific posters on ePosters
  • More than 5,300+ 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

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
American Journal of Obstetrics & Gynecology Publishes New Clinical Study of OVA1 Test
Significantly superior early-stage sensitivity shown versus CA125, modified ACOG guidelines or overall clinical assessment in premenopausal and postmenopausal women planning surgery.
Thursday, November 14, 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 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
Accelerating the Detection of Foodborne Bacterial Outbreaks
The speed of diagnosis of foodborne bacterial outbreaks could be improved by a new technique developed by researchers at the Georgia Institute of Technology.
Cancer Gene Predicts Treatment Response in Leukaemia
Study indicates the patients suffering from a lethal for of acute myeloid leukemia may live longer when receiving milder chemotherapy drugs.
New Diagnostic Tool for Familial Mediterranean Fever
A new tool developed by researchers at VIB and Ghent University could improve the process of diagnosing Familial Mediterranean Fever.
'Lab on the Skin' for Sweat Analysis
Northwestern University researchers develop a low-cost wearable electronic device that collects and analyzes sweat for health monitoring.
Molecular Signature for Aggressive Brain Tumor Uncovered
Researchers have identified genetic mutations in a highly agressive brain cancer that distinguishes the agressive, from the benign forms of the cancer.
Malaria Parasite Evades Rapid Test Detection in Children
A study at the University of North Carolina found that gene deletion poses a threat to Malaria eradication efforts.
Novel Urine Test to Predict High-Risk Cervical Cancer
Preliminary studies affirm accuracy and potential cost savings to screen for virus-caused malignancy.
GFC Diagnostics Wins Longitude Prize Discovery Award
The global award was won for the development of a cheap, quick and simple MRSA Test.
Understanding Circulating Tumour Cells
Research team develops new tool to track traveling cancer cells in the bloodstream.
Blood Glucose Monitoring Device for Diabetes
Novel breathalyzer offers alternative to finger stick testing for people with type 1 and 2 diabetes.
Skyscraper Banner

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
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!