American Journal of Obstetrics & Gynecology Publishes New Clinical Study
Showing Positive Performance of Vermillion's OVA1 Test in Presurgical
Detection of Early-Stage Ovarian Cancer
Significantly Superior Early-Stage Sensitivity Shown versus CA125, Modified
ACOG Guidelines or Overall Clinical Assessment in Premenopausal and
Postmenopausal Women Planning Surgery
WASHINGTON, Nov. 12, 2013
WASHINGTON, Nov. 12, 2013 /PRNewswire/ --A new study of OVA1® clinical
performance in the presurgical detection of ovarian cancer, entitled "Clinical
Performance of a Multivariate Index Assay For Detecting Early-Stage Ovarian
Cancer," has been published in The American Journal of Obstetrics &
Led by Dr. Robert E. Bristow (UC Irvine Healthcare) and Dr. Frederick R.
Ueland (U. Kentucky), the new analysis focuses on presurgical detection of
early-stage ovarian cancer among 1,016 ovarian mass surgery patients in two
previous pivotal trials conducted in 2007 and 2012.
The study compared OVA1 performance in early-stage ovarian cancer to commonly
used cancer risk assessment protocols: overall clinical assessment, the CA125
biomarker or modified-American College of Obstetricians and Gynecologists
(mod-ACOG) guidelines for evaluation of suspicious pelvic masses. Vermillion,
Inc. (NASDAQ: VRML), the multivariate diagnostics company which developed and
currently markets the test, reported the findings today at the American
Association of Gynecologic Laparoscopists "42^nd AAGL Global Congress on
Minimally Invasive Gynecology."
"Early-stage ovarian cancer constitutes an important opportunity to improve
survival and care for this most deadly gynecologic cancer," said Dr. Bristow.
"However, as evidenced by recent studies, most ovarian cancer patients fail to
be referred to the doctors and hospitals best equipped to treat them,
resulting in unfortunate consequences.
"Our new study demonstrates OVA1's ability to detect the majority of all
early-stage ovarian cancers prior to surgery and thereby aid in appropriately
involving a gynecologic oncologist in their care. Even among premenopausal
patients where primary ovarian cancer prevalence was only 15%, clinical
assessment with OVA1 detected early-stage ovarian cancer with nearly 90%
sensitivity. This is a very encouraging development for diagnosis and
treatment of ovarian cancer."
METHODS AND FINDINGS
As a benchmark of usual care, physicians were required to predict whether
ovarian masses were malignant or benign following overall clinical assessment,
which included physical examination and imaging, family history, and
laboratory tests (including CA125, if used). Overall success of clinical
assessment in predicting an early-stage malignancy (confirmed by pathology)
was 68.6% (59 of 86 malignancies), while 31.4% were mistakenly predicted to be
benign. For stage I malignancies the percent detected fell to 63.9% (39/61),
with 36.1% mistakenly predicted to be benign. Adding OVA1 to clinical
assessment successfully identified 95.3% of early-stage cancers (82/86) and
93.4% of stage I malignancies (57/61) – a reduction in cancers missed of 85%
(early-stage) and 82% (stage I), respectively over clinical assessment alone.
Among three risk-stratification methods compared directly for early-stage
cancer detection, OVA1 showed the highest sensitivity (91.9%, or 79/86). OVA1
sensitivity was significantly higher than either benchmark method: sensitivity
of the mod-ACOG guidelines was 76.7% (66/86) while CA125 sensitivity was 62.8%
(54/86). The number of malignancies incorrectly stratified as low risk by
CA125, mod-ACOG and OVA1 was 37.2%, 23.3% and 8.1%, respectively.
Early-stage cancer detection by OVA1 was 85.7% among premenopausal patients
and 94.8% among postmenopausal patients. In contrast, CA125 alone correctly
classified just 35.7% in premenopausal patients and 75.9% in postmenopausal
patients. Used as intended together with clinical assessment, OVA1 sensitivity
was 89.3% and 98.3% for pre- and post-menopausal early-stage cancer detection.
Dr. Donald Munroe, Vermillion's chief scientific officer and SVP of business
development, commented: "Knowing the importance of referring early-stage
ovarian cancer to gynecologic oncologists for optimal care, we are very
encouraged by this latest clinical study. OVA1 significantly outperformed the
three common risk assessment protocols in detecting early-stage cancers, which
present the best opportunity for favorable outcomes or cure if appropriately
handled. These results highlight the potential of OVA1 to replace the inferior
off label use of CA125 and improve the presurgical management of ovarian
cancer, which benefits patients, physicians and payers alike."
Longoria TC, Ueland FR, Zhang Z, et al. Clinical performance of a multivariate
index assay for detecting early-stage ovarian cancer. Am J Obstet Gynecol
2013;209 (in press).
About American Journal of Obstetrics & Gynecology
The American Journal of Obstetrics & Gynecology (www.AJOG.org), known as "The
Gray Journal," presents comprehensive coverage of the obstetrics and
gynecology specialty, including maternal-fetal medicine, reproductive
endocrinology/infertility, and gynecologic oncology.
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 gynecologic
oncology and women's health.
The company's lead diagnostic, OVA1®, is a blood test for pre-surgical
assessment of ovarian tumors for malignancy, using an innovative algorithmic
approach. As the first FDA-cleared, protein-based In Vitro Diagnostic
Multivariate Index Assay, OVA1 represents a new class of software-based
diagnostics. For additional information, including published clinical trials,
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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