U.S. Army and Vermillion to Assess Health and Economic Benefits of OVA1 as a
Standard of Care
AUSTIN, Texas, April 17, 2013
AUSTIN, Texas, April 17, 2013 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML),
a molecular diagnostics company focused on gynecologic cancers and women's
health,announced the signing of a cooperative research and development
agreement (CRADA) with the U.S. Army Medical Research and Materiel Command
The agreement kicks off a project titled, "Cost Reduction Using OVA1 in a
Treatment Algorithm for Adnexal Masses in Women," and follows a January 2012
decision by the U.S. Department of Defense to cover OVA1® testing. The
two-phase study will investigate the cost-benefit profile of OVA1 testing as a
presurgical standard of care in women with pelvic masses, and assess OVA1
clinical utility in a managed care setting.
Phase 1 will retrospectively assess medical outcomes and total cost of care to
establish historical benchmarks and estimate potential benefits of OVA1
utilization. Phase 2 will involve a multi-center prospective clinical study
within the Western Regional Command to assess OVA1 as a standard of care
across a large sector of the U.S. Armed Forces.
An Army spokesperson for the study stated: "The Department of Defense is
committed to improving and streamlining medical care for our female service
members and dependent family members. And at the same time, the DoD is working
hard to reduce out-of-network medical costs, avoidable travel costs and time
away from family, all of which drain resources from where they are needed. We
are excited by previous publications on OVA1's diagnostic performance, which
suggest the potential to positively impact both of these important goals.
"With this project, we hope to measure for the first time the real-world
impact of OVA1 on medical and health economic outcomes, compared with accurate
and holistic benchmarks. For example, the sensitive detection of stage I
ovarian cancer has always been difficult. But when appropriately detected and
treated, greater than 90% complete cure rates have been reported. This is just
one example of benefits we expect to see with a sensitive test like OVA1 when
implemented as a standard of care across our managed care network."
Thomas McLain, president and chief executive officer of Vermillion, added:
"Our clinical collaboration with the U.S. Armed Forces is an important step
towards OVA1 becoming a presurgical standard of care in women with pelvic
masses. They are uniquely positioned to measure the total cost of care and
medical outcomes across a large patient population in a standardized and
rigorous manner. And we could not ask for a research partner with a higher
profile or standards of excellence."
References herein to the activities of the U.S. Army, the Department of
Defense, Government investigators, a Federal laboratory or the U.S. Government
does not imply an endorsement or recommendation of the products or services of
Vermillion, Inc. by any U.S. Government entity.
As the Army's medical materiel developer, USAMRMC focuses on medical research,
development and acquisition, and medical logistics management. USAMRMC
headquarters is located at Fort Detrick, Md., and supports 12 subordinate
commands and 6 executive agencies located throughout the world.
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 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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