Vermillion's OVA1 Receives New Statement by Society of Gynecologic Oncology
AUSTIN, Texas, June 11, 2013
AUSTIN, Texas, June 11, 2013 /PRNewswire/ --Vermillion, Inc.'s (NASDAQ:
VRML), a multivariate diagnostics company focused on gynecologic cancers and
women's health, 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
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
The new statement does two things:
oRefers 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.
oPlaces 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
Vermillion, Inc. (NASDAQ: VRML) 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,
vascular medicine and women's health.
The company's lead diagnostic, OVA1®, is a blood test for pre-surgical
assessment of tumors for malignancy, using a unique multi-biomarker approach.
In a published clinical trial, OVA1 achieved 99% sensitivity in detecting
epithelial ovarian cancers (EOC). This included 96% sensitivity for stage I
EOC, the earliest and curable EOC stage, compared with 57% for the
conventional biomarker CA125. In addition, OVA1 found 82% of malignancies
missed by non-specialist pre-surgical assessment, and it increased detection
of malignancy over ACOG guidelines from 77% to 94%. As the first
protein-based, In Vitro Diagnostic Multivariate Index Assay (IVDMIA) cleared
by the FDA, OVA1 also represents a new class of software-based diagnostics.
Additional information about these published clinical trials is available on
Vermillion's website at www.vermillion.com.
Certain matters discussed in this press release contain forward-looking
statements that involve significant risks and uncertainties, including
statements regarding Vermillion's plans, objectives, expectations and
intentions. These forward-looking statements are based on Vermillion's current
expectations. The Private Securities Litigation Reform Act of 1995 provides a
"safe harbor" for such forward-looking statements. In order to comply with the
terms of the safe harbor, Vermillion notes that a variety of factors could
cause actual results and experience to differ materially from the anticipated
results or other expectations expressed in such forward-looking statements.
Factors that could cause actual results to materially differ include but are
not limited to: (1) uncertainty as to Vermillion's ability to protect and
promote its proprietary technology; (2) Vermillion's lack of a lengthy track
record successfully developing and commercializing diagnostic products; (3)
uncertainty as to whether Vermillion will be able to obtain any required
regulatory approval of its future diagnostic products; (4) uncertainty of the
size of market for its existing diagnostic tests or future diagnostic
products, including the risk that its products will not be competitive with
products offered by other companies, or that users will not be entitled to
receive adequate reimbursement for its products from third party payers such
as private insurance companies and government insurance plans; (5) uncertainty
that Vermillion has sufficient cash resources to fully commercialize its tests
and continue as a going concern; (6) uncertainty whether the trading in
Vermillion's stock will become significantly less liquid; and (7) other
factors that might be described from time to time in Vermillion's filings with
the Securities and Exchange Commission. All information in this press release
is as of the date of this report, and Vermillion expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to any
such statements to reflect any change in Vermillion's expectations or any
change in events, conditions or circumstances on which any such statement is
based, unless required by law.
This release should be read in conjunction with the consolidated financial
statements and notes thereto included in our most recent reports on Form 10-K
and Form 10-Q. Copies are available through the SEC's Electronic Data
Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov.
Investor Relations Contact:
Liolios Group, Inc.
SOURCE Vermillion, Inc.
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