American Journal of Obstetrics & Gynecology Publishes New Clinical Study
Showing Positive Performance of Vermillion's Ovarian Cancer Test, OVA1
Triage Sensitivity Significantly Improved without a Predicted Increase in Rate
of Specialist Referral
WASHINGTON, Nov. 12, 2013
WASHINGTON, Nov. 12, 2013 /PRNewswire/ --A new clinical study published in
The American Journal of Obstetrics & Gynecology has reported superior
sensitivity of OVA1® for presurgical triage of ovarian cancer in a large
intended-use population, compared with commonly used risk assessment methods.
The new study compared OVA1 performance to benchmark triage methods, within a
combined cohort of 770 ovarian mass surgery patients (including 164
malignancies) from two independent but related OVA1 pivotal trials conducted
in 2007 and 2012. The study also compared the actual rate of patient referral
from non-specialist physicians to gynecologic oncologists (GO's) with rates
predicted from clinical assessment, OVA1, CA125 or from the modified-American
College of Obstetricians and Gynecologists (mod-ACOG) guidelines. 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."
Dr. Robert E. Bristow, lead author of the study and director of Gynecologic
Oncology Services at UC Irvine Healthcare, commented: "Despite widely endorsed
treatment standards published by the National Comprehensive Cancer Network,
several studies published earlier this year show that only a minority of
ovarian cancer patients actually receive treatment by the doctors and
hospitals best equipped to care for them. Our new publication shows that the
FDA-cleared OVA1 test achieves significantly higher sensitivity than two
commonly used methods. And despite lower specificity, the referral rates
predicted by OVA1 were roughly comparable to actual clinical practice."
METHODS AND FINDINGS
Physicians participating in the study were required to predict whether ovarian
masses were malignant or benign following clinical assessment. The clinical
assessment stipulated physical examination and imaging, family history, and
laboratory tests (including CA125, if used). OVA1 performance as a risk
stratification test was compared with clinical assessment, Predicted and
actual referral rates were analyzed and predictions were compared with final
Clinical assessment correctly predicted 120 of 164 malignancies (73.2%), while
44 were mistakenly predicted to be benign (26.8%). Among three
risk-stratification methods compared, OVA1 showed the highest sensitivity
(148/164, or 90.2%). OVA1 sensitivity was significantly higher than either
benchmark method: sensitivity of the mod-ACOG guidelines was 130/164 (79.3%)
while CA125 sensitivity was 112/164 (68.4%). The number of malignancies
incorrectly stratified as low risk by CA125, mod-ACOG and OVA1 was 52 (31.6%),
34 (20.7%) and 16 (9.8%), respectively.
OVA1 performance predicted an overall referral rate of 55.7%, slightly lower
than the actual referral rate of 60.0% observed across all patients in the
study. Despite the other risk stratification methods predicting lower overall
referral rates, approximately 48-52% of patients rated as low risk were
nevertheless referred in actuality. Reasons for these unexpected referrals
were not evident.
"This study, focused on intended-use patients enrolled through 44 sites
nationwide, found that OVA1 sensitivity was statistically superior to CA125 or
the other risk stratification protocols examined," stated Dr. Donald Munroe,
Vermillion's chief scientific officer and SVP of business development. "While
high sensitivity and negative predictive value are diagnostic imperatives for
presurgical ovarian cancer triage, the work also shed light on patient
referral patterns with or without OVA1. Notably, the predicted OVA1 referral
rate was comparable to actual GO referrals using physicians' usual methods.
This finding suggests that OVA1's benefits may be achievable without
dramatically altering overall referral rates. We now plan to transition into
additional health economics, efficiency and outcomes studies with leading
collaborators, which will be announced as we move forward."
The study, "Impact of a Multivariate Index Assay on Referral Patterns for
Surgical Management of an Adnexal Mass," was co-authored by Dr. Bristow along
with Dr. Frederick R. Ueland of the University of Kentucky, as well as
investigators from The Johns Hopkins University and scientists from
Bristow RE, Hodeib M, Smith A, et al. Impact of a multivariate index assay on
referral patterns for presurgical management of an adnexal mass. 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 the company's most recent reports on
Form 10-K and Form 10-Q. Copies are available through EDGAR at www.sec.gov.
Investor Relations Contact:
Liolios Group, Inc.
SOURCE Vermillion, Inc.
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