Gynecologic Oncology Publishes New Clinical Study Showing Positive Performance
of OVA1, Vermillion's Ovarian Cancer Test
OVA1 Performance in Early-Stage Ovarian Cancer and Premenopausal Women Further
Validates its Clinical Utility for Pre-Surgical Assessment of Ovarian Tumors
AUSTIN, Texas, Nov. 28, 2012
AUSTIN, Texas, Nov. 28, 2012 /PRNewswire/ -- Gynecologic Oncology, the
prestigious medical journal of the Society for Gynecologic Oncology, has
published the second prospective clinical study of OVA1® which demonstrated
the positive performance of the multi-biomarker test in the triage of
early-stage ovarian cancer.
Vermillion, Inc. (NASDAQ: VRML), the molecular diagnostics company which
developed and currently markets the test, had reported positive top-line
results of the study in July. Referred to as "OVA500," the study confirms and
extends the findings of the first OVA1 pivotal study published last year in
Obstetrics & Gynecology by Dr. Fred Ueland of the University of Kentucky.
The OVA500 results were published online by Gynecologic Oncology on November
22 in the article, "Ovarian Malignancy Risk Stratification of the Adnexal Mass
Using a Multivariate Index Assay." The article was authored by Dr. Robert E.
Bristow, the director of Gynecologic Oncology Services at UC Irvine Healthcare
and former director of gynecologic oncology at Johns Hopkins.
The multi-center study investigated OVA1 performance in the pre-surgical
detection of malignancy among 494 women prospectively enrolled from
non-gynecologic oncology practices. Sensitivity across all types of ovarian
cancers was 96% when OVA1 was added to routine clinical assessment, and this
result was nearly identical to the first pivotal study. Importantly, within
the test group OVA1 identified 83% of cancers missed by clinical assessment
and 71% of cancers missed by CA125.
"The publication of the OVA500 study advances our strategic plan to increase
physician adoption and payer coverage, leading to incorporation of OVA1 into
the standard of care for ovarian cancer," said Bruce A. Huebner, Vermillion's
interim CEO. "The publication of a second independent prospective,
multi-center study such as this is considered critically important by many
doctors, payers and professional societies. Test data generated from nearly
500 patients enrolled at 27 centers, including 17 new sites, demonstrated the
robust performance of OVA1 across diverse geographic settings."
"Both our initial clinical study and OVA500 showed that all combined
modalities used in routine clinical assessment failed to predict cancers at a
rate of more than 24%. But when adding OVA1, the rate of cancers missed was
little more than 4% in each study," continued Huebner. "Now more than ever, we
believe the evidence warrants that OVA1 be incorporated into a standardized
pre-surgical assessment of adnexal masses."
Dr. Bristow commented: "New tools for the sensitive detection and referral of
ovarian cancer are badly needed, given the more than 15,000 women who die
every year from this disease in the U.S. The OVA500 study confirmed in a new
patient cohort that about 96% of malignancies were detected by adding OVA1 to
clinical assessment, and these included 91% of early-stage disease and 94% of
premenopausal cancers. At the same time, the majority of subjects with benign
disease were classified as low risk, with 98% of negative tests resulting in a
benign pathology finding. Thanks to diagnostic advances like OVA1, there is
real hope that the majority of women with ovarian cancer will undergo surgery
by a qualified gynecologic oncologist, which is one of the most powerful
determinants of survival."
The OVA500 study abstract and publication is available here.
OVA500 Study Summary:
Results (N=494)^1 Clinical CA125-II OVA1 OVA1 & CI
Sensitivity % 73.9 73.9 92.4 95.7
Specificity % 92.5 94.5 53.5 50.7
PPV % 69.4 75.6 31.3 30.8
NPV % 93.9 94.1 96.8 98.1
% Cancers Missed 26.1 26.1 7.6 4.3
First OVA1 Study Summary:
Results (N=516)^2 Clinical CA125-II OVA1 OVA1 & CI
Sensitivity % 75.1 68.9 92.5 95.6
Specificity % 79.1 83.7 42.8 34.6
PPV % 62.0 65.2 42.3 39.8
NPV % 87.5 85.8 92.7 94.6
% Cancers Missed 24.9 31.1 7.5 4.4
1. Bristow, et al., Gynecologic Oncology, November 2012
2. Ueland FR,DeSimoneCP,SeamonLG, et
About Gynecologic Oncology
Gynecologic Oncology is the official publication of Society for Gynecologic
Oncology, and has been recognized as having the highest impact factor rating
of all journals worldwide that publish research on gynecological cancer.
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. Additional information about Vermillion
can be found 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 payors 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 of finding a suitable
successor chief executive officer; (7) uncertainty whether the trading in
Vermillion's stock will become significantly less liquid; and (8) other
factors that might be described from time to time in Vermillion's filings with
the Securities and Exchange Commission (SEC). 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 the company's most recent reports on
Form 10-K and Form 10-Q. Copies are available through EDGAR at www.sec.gov.
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