Ciphergen Selects Emergo Group, Inc. as Authorized Representative in Europe
19 Décembre 2006 - 3:00PM
PR Newswire (US)
FREMONT, Calif., Dec. 19 /PRNewswire-FirstCall/ -- Ciphergen
Biosystems, Inc. (NASDAQ:CIPH) today announced that it has engaged
Emergo Group, Inc. to help gain regulatory clearance of Ciphergen's
ovarian tumor triage test in various European countries. "Having
obtained positive preclinical data in our ovarian cancer diagnostic
program in studies performed with samples from European patients,
we are seeking to rapidly pursue registration and commercialization
of our ovarian tumor test in Europe," said Gail S. Page, President
and CEO of Ciphergen. "The Emergo Group has an outstanding
reputation for quality, value, and customer service that fits our
efforts to move quickly to commercialize this test in at least one
European country in 2007." Emergo Europe will act as the regulatory
liaison between Ciphergen and the National Ministries of Health in
Europe. Emergo Europe will register Ciphergen's in vitro
diagnostics (IVDs) through the regulatory agencies in each country
and provide consulting support on product packaging and labeling.
Emergo is an ISO (International Standards Organization) registered
medical device consulting firm with expertise in medical device
regulatory affairs, CE marking and Good Manufacturing Practices
(GMP) and ISO 13485 quality system implementation. "We are pleased
to assist Ciphergen in their efforts to expeditiously register the
ovarian tumor triage test in Europe as soon as possible," said Rene
van de Zande, President and CEO of Emergo Group. About Ciphergen's
Ovarian Cancer Diagnostic Program Ciphergen has an advanced
diagnostic program in ovarian cancer and has developed a panel of
biomarkers that provides risk stratification information for
ovarian cancer based on a series of studies involving over 2,000
clinical samples from more than five sites. Ciphergen is
undertaking a prospective clinical trial to support submission to
the U.S. Food and Drug Administration for clearance as an in vitro
diagnostic. Ciphergen has a strategic alliance with Quest
Diagnostics focused on commercializing the ovarian tumor triage
test. Quest also has the option to develop and commercialize two
additional Ciphergen tests. In addition to developing a diagnostic
test designed to distinguish between benign and malignant pelvic
masses, studies are underway to predict recurrence of ovarian
cancer and to provide additional tools to aid physicians in
triaging women considered at high risk of ovarian cancer.
Ciphergen's comprehensive diagnostic development program is being
conducted with several leading collaborators at The Johns Hopkins
School of Medicine, The University of Texas M.D. Anderson Cancer
Center, University College London, and the University of Kentucky.
About Ovarian Cancer Commonly known as the "silent killer," ovarian
cancer leads to approximately 14,000 deaths each year in the United
States. Approximately 23,000 new cases are diagnosed each year,
with the majority in patients diagnosed with late stage disease
where the cancer has spread beyond the ovary. The prognosis is poor
in these patients, leading to the high mortality from this disease.
A diagnostic test is needed that can provide adequate predictive
value to stratify patients with a pelvic mass into high risk of
invasive ovarian cancer versus those with low risk. About Ciphergen
Ciphergen Biosystems, Inc. is dedicated to the discovery,
development and commercialization of novel high-value diagnostic
tests that help physicians diagnose, treat and improve outcomes for
patients. Ciphergen, along with its prestigious scientific
collaborators, has ongoing diagnostic programs in oncology,
cardiology and women's health with an initial focus in ovarian
cancer. Based in Fremont, California, more information about
Ciphergen can be found on the Web at http://www.ciphergen.com/ .
Safe Harbor Statement Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements. For
purposes of the Private Securities Litigation Reform Act of 1995
(the "Act"), Ciphergen disclaims any intent or obligation to update
these forward-looking statements, and claims the protection of the
Safe Harbor for forward-looking statements contained in the Act.
Examples of such forward-looking statements include statements
regarding the registration and commercialization of Ciphergen's
test in Europe. Actual results may differ materially from those
projected in such forward-looking statements due to various
factors, including the possibility that despite the efforts of the
company and its partners, the registration and commercialization of
the tests may not occur as quickly as expected or at all. Investors
should consult Ciphergen's filings with the Securities and Exchange
Commission, including its Form 10-Q filed November 20, 2006, for
further information regarding these and other risks related to the
Company's business. NOTE: Ciphergen is a registered trademark of
Ciphergen Biosystems, Inc. DATASOURCE: Ciphergen Biosystems, Inc.
CONTACT: Sue Carruthers, Investor Relations, Ciphergen Biosystems,
Inc., +1-510-505-2233; or media, Daryl Messinger of WeissComm
Partners, +1-415-999-2361, for Ciphergen Biosystems, Inc. Web site:
http://www.ciphergen.com/
Copyright
Ciphergen Biosystems (NASDAQ:CIPH)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Ciphergen Biosystems (NASDAQ:CIPH)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024
Real-Time news about Ciphergen Biosystems (MM) (NASDAQ): 0 recent articles
Plus d'articles sur Ciphergen Biosystems (MM)