U.S. Food and Drug Administration Clears Vermillion's OVA1(TM) Test to Determine Likelihood of Ovarian Cancer in Women with Pelv
September 11 2009 - 3:01PM
PR Newswire (US)
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 http://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
http://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 DATASOURCE: Quest
Diagnostics Incorporated; Vermillion CONTACT: 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, Web Site:
http://www.questdiagnostics.com/ http://www.vermillion.com/
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