Navigation Links
FDA Clears a Test for Ovarian Cancer
Date:9/11/2009

Test can help identify potential malignancies, guide surgical decisions

SILVER SPRING, Md., Sept. 11 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," said Jeffrey Shuren, M.D., J.D., acting director of the FDA's Center for Devices and Radiological Health.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
2. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
3. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
4. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
5. Cancer Treatment Centers of America(R) Studies Treatment That Aims Chemotherapy Directly at Ovarian Cancer Cells
6. Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA
7. Access Pharmaceuticals Announces Positive ProLindac(TM) Phase 2 Ovarian Cancer Clinical Trial Results
8. Pivotal Data Published For First Biomarker Combination Test to Determine Risk of Ovarian Cancer in Women Who Present With Pelvic Mass
9. Sunesis Pharmaceuticals Presents Clinical Trial Data of Voreloxin in Patients with Acute Myeloid Leukemia and Ovarian Cancer at the Chemotherapy Foundation Symposium
10. AEterna Zentaris Reaches 2nd Stage of Patient Recruitment for Phase 2 Trial in Ovarian Cancer with the Innovative LHRH Receptor Targeted Conjugate, AEZS-108
11. Abeome and Cato Research to Collaborate on Ovarian Cancer Therapeutic
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/15/2017)... , May 15, 2017 Enterin Inc., a ... and developing novel compounds to treat Parkinson,s disease (PD), ... study is a Phase 1/2a randomized, controlled, multicenter study involving ... It will enroll 50 patients over a 9-to-12-month period. The ... in 10 patients with PD. Participating sites include ...
(Date:5/10/2017)... , May 10, 2017 Global Health Intelligence ... Latin America , published its 2017 ranking of ... is based on extensive data analysis from GHI,s hospitals ... hospitals database for the region. The GHI database covers 86% ... offering more than 130 data points for each institution in ...
(Date:5/9/2017)... May 9, 2017 Zimmer Biomet Holdings, Inc. ... healthcare, today announced it has earned a spot on ... list. The Company was ranked among 500 U.S. employers ... and Healthcare Equipment and Services. The annual ... an anonymous, independent survey of over 30,000 employees across ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... May 24, 2017 , ... Dr. Manju R. Kejriwal, ... ClearCorrect orthodontics, with or without a referral. Dr. Kejriwal understands the emotional and ... convenient, clear braces in Cincinnati, OH. Patients no longer need to feel the esthetic ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... II of the HP3 (High-Performance Periodontal Practice) continuing education (CE) series. As a ... advancements in his field by attending numerous CE courses each year. His recent ...
(Date:5/24/2017)... ... 2017 , ... If you are thinking of a visit to San Francisco , fall ... the perfect time to visit. , Business Architecture Associates is pleased to offer 5 days ... as a 4-½ day package for individuals, and as 4-½ day corporate package for up ...
(Date:5/24/2017)... ... May 24, 2017 , ... Fiberstar, ... solutions for the food and beverage industry offers Citri-Fi®, a natural citrus fiber, ... the purchasing decision process. As a result, labels need to deliver simple, transparent ...
(Date:5/23/2017)... ... ... Axiad IDS , a leading provider of trusted identities for enterprise, ... a “Top 25 Cybersecurity Companies 2017.” Axiad IDS received this honor in ... address potential cybersecurity threats before they happen. The annual list of top ...
Breaking Medicine News(10 mins):