Read
- Planetary alignment peaks with celestial show this weekend
- UK fighters escort Pakistan plane to airport, two arrests
- Arizona jury foreman says believed Jodi Arias was abused
- Judge rules against 'America's toughest sheriff' in racial profiling lawsuit
- Stockholm calmer but violence spreads outside Swedish capital
|
Sponsored Links
U.S. Food and Drug Administration Clears Vermillion's OVA1(TM) Test to Determine...
* Reuters is not responsible for the content in this press release.
U.S. Food and Drug Administration Clears Vermillion's OVA1(TM) Test to
Determine Likelihood of Ovarian Cancer in Women with Pelvic Mass
First lab test that can indicate ovarian cancer prior to biopsy or exploratory
surgery
MADISON, N.J. and FREMONT, Calif., Sept. 11 /PRNewswire-FirstCall/ -- The U.S.
Food and Drug Administration (FDA) today cleared the OVA1(TM) Test, the first
blood test that, prior to surgery, can help physicians determine if a woman is
at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory
test that can indicate the likelihood of ovarian cancer with high sensitivity
prior to biopsy or exploratory surgery, even if radiological test results fail
to indicate malignancy. The test was developed by Vermillion, Inc. (OTC:
VRMLQ.PK), a molecular diagnostics company, in cooperation with Quest
Diagnostics (NYSE: DGX), the world's leading provider of cancer diagnostics.
Quest Diagnostics, which is a long-time investor in research and development
of the OVA1 technology, has exclusive rights to offer the test to the clinical
reference laboratory market in the U.S. for three years.
"When combined with other clinical information, the OVA1 biomarker panel can
help assess the likelihood of malignancy of an ovarian tumor before surgery
and facilitate decisions about referral to a gynecologic oncologist," said
Frederick R. Ueland, M.D., principal investigator of the prospective,
multi-center OVA1 clinical trial. Dr. Ueland is an associate professor
gynecologic oncology at the University of Kentucky's Markey Cancer Center.
The OVA1 Test is an in vitro diagnostic multivariate index (IVDMIA) test that
combines the results of five immunoassays using a proprietary unique algorithm
to produce a single numerical score indicating a women's likelihood of
malignancy. The OVA1 Test provides a new option in the pre-operative
evaluation to help physicians assess if a pelvic mass is benign or malignant
in order to help determine whether to refer a woman to a gynecologic
oncologist for surgery. Numerous clinical practice guidelines recommend that
women with ovarian cancer be under the care of a gynecologic oncologist.
However, only an estimated one third of women who undergo surgery for possible
ovarian cancer are referred to these specialist surgeons for their surgery.(1)
Vermillion received the Society for Gynecologic Oncologists (SGO) Basic
Science Poster Award for an abstract on the performance of its OVA1 Test
presented at SGO's 38th Annual Meeting on Women's Cancer in 2007. In reviewing
the test application, the FDA evaluated results of a prospective, double-blind
clinical trial which included 27 demographically mixed sites representative of
institutions where ovarian tumor subjects may undergo a gynecological
examination.
"Surgery in the hands of a gynecologic oncologist is usually associated with
more favorable patient outcomes," said Jon R. Cohen, M.D., chief medical
officer and senior vice president, Quest Diagnostics. "Physicians often do
not know if a woman's pelvic mass is malignant or benign until she undergoes
surgery. The OVA1 Test is the first FDA-cleared blood test to help clinicians
determine whether to refer a woman to a gynecologic oncologist or have a
gynecologic oncologist present at the time of surgery. We believe this test
will help drive more favorable patient outcomes."
"Unfortunately, advances in ovarian cancer diagnosis and treatment are few and
far between. It is fitting that September, Ovarian Cancer Awareness Month,
marks FDA's clearance of OVA1, a test that represents an important step
forward toward improved outcomes," said Gail S. Page, executive chairperson of
the board of directors of Vermillion. "Quest Diagnostics had the foresight to
recognize the potential value of this novel multivariate assay and supported
its development. We look forward to collaborating to bring this new diagnostic
option to the many women who will benefit from specialist care."
The FDA clearance of OVA1 makes Quest Diagnostics the only diagnostic testing
company to offer FDA cleared tests for ovarian cancer in the pre- and
post-surgical settings. In addition to offering the OVA1 Test, Quest
Diagnostics was the first laboratory company to provide a new lab test that
the FDA cleared in the third quarter of 2008 as an aid for monitoring for
recurrence of epithelial ovarian cancer.
The OVA1 Test will be available for physician use in the fourth quarter of
this year.
Ovarian cancer is the leading cause of death from gynecologic cancers in the
United States and the fifth-leading cause of cancer deaths in women.(2)
Approximately 21,600 new cases of ovarian cancer will be diagnosed in the U.S.
in 2009, and approximately 14,600 women will die of the disease.(3)
About the OVA1 Test
The OVA1 Test is a qualitative serum test that combines the results of five
immunoassays into a single numerical score. It is indicated for women who meet
the following criteria: over age 18, ovarian adnexal mass present for which
surgery is planned, and not yet referred to an oncologist. The test utilizes
five well-established biomarkers --- Transthyretin (TT or prealbumin),
Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr)
and Cancer Antigen 125 (CA 125 II) --- and a proprietary algorithm to
determine the likelihood of malignancy in women with pelvic mass for whom
surgery is planned.
The OVA1 Test is an aid to further assess the likelihood that malignancy is
present when the physician's independent clinical and radiological evaluation
does not indicate malignancy. The test should not be used without an
independent clinical/radiological evaluation and is not intended to be a
screening test or to determine whether a patient should proceed to surgery.
Incorrect use of the OVA1 Test carries the risk of unnecessary testing,
surgery, and/or delayed diagnosis.
About Vermillion
Vermillion, Inc. is dedicated to the discovery, development and
commercialization of novel high-value diagnostic tests that help physicians
diagnose, treat and improve outcomes for patients. Vermillion, along with its
prestigious scientific collaborators, has diagnostic programs in oncology,
hematology, cardiology and women's health. Vermillion is based in Fremont,
California. Additional information about Vermillion can be found on the Web at
www.vermillion.com.
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing,
information and services that patients and doctors need to make better
healthcare decisions. The company offers the broadest access to diagnostic
testing services through its network of laboratories and patient service
centers, and provides interpretive consultation through its extensive medical
and scientific staff. Quest Diagnostics is a pioneer in developing innovative
diagnostic tests and advanced healthcare information technology solutions that
help improve patient care. Additional company information is available at
www.QuestDiagnostics.com.
(1) Journal of the National Cancer Institute, Vol. 98, No. 3, February 1, 2006
(2) Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA
Cancer J Clin. 2000;50(1):7-33
(3) 2009 American Cancer Society
OVA1(TM) Test is a trademark of Vermillion Inc.
Quest, Quest Diagnostics, the associated logo, and all associated Quest
Diagnostics marks are the registered trademarks of Quest Diagnostics. All
third party marks - (R)' and (TM)' - are the property of their respective
owners.
Contacts:
Quest Diagnostics:
Media: Wendy Bost 973-520-2800
Investors: Kathleen Valentine 973-520-2900
Vermillion:
Jill Totenberg
The Totenberg Group
Tel: 212 994 7363
jtotenberg@totenberggroup.com
SOURCE Quest Diagnostics Incorporated; Vermillion
Quest Diagnostics, Media, Wendy Bost, +1-973-520-2800, or Investors, Kathleen
Valentine, +1-973-520-2900; or Vermillion, Jill Totenberg, The Totenberg
Group, +1-212-994-7363, jtotenberg@totenberggroup.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.


Follow Reuters