Promising Results Published in JAMA on Biomarkers for Early Diagnosis of Infections Associated With Preterm Birth
August 02 2004 - 10:00AM
PR Newswire (US)
Promising Results Published in JAMA on Biomarkers for Early
Diagnosis of Infections Associated With Preterm Birth Discovery of
Biomarkers Enabled by Ciphergen's ProteinChip(R) System FREMONT,
Calif., Aug. 2 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc.
(NASDAQ:CIPH) announced today that the SELDI ProteinChip(R)
technology was used to discover several biomarkers that showed
promising results in the early diagnosis of intra-amniotic
infection (IAI), a major cause of preterm birth. This study,
"Diagnosis of Intra-amniotic Infection by Proteomic Profiling and
Identification of Novel Biomarkers," which was published in the
June 28 issue of the Journal of American Medical Association
(JAMA), also reported that these biomarkers could be detected in
serum, suggesting that development of a non-invasive diagnostic
test may be possible. Senior author of the study, Srinivasa R.
Nagalla, M.D., Associate Professor and Director for Center for
Biomarker Discovery at Oregon Health and Science University,
stated, "Protein profiling using SELDI enabled the discovery of
these biomarkers in both amniotic fluid and serum. Our findings
hold promise for the future development of rapid and non-invasive
assays to detect IAI during pregnancy, which would allow physicians
to target women at high risk for premature delivery for specific
therapeutic intervention such as antibiotics or anti-inflammatory
drugs." "We applaud the research team involved in this work for
their application of SELDI to this important medical issue, and
look forward to continuing our support of their efforts in
developing potential diagnostic assays," stated Gail S. Page,
President of Ciphergen's Diagnostics Division. "Ciphergen's
clinical proteomics platform, based on our core SELDI ProteinChip
technology, is enabling researchers to rapidly discover, validate
and characterize novel biomarkers," said Martin Verhoef, President
of Ciphergen Biosystems. "This study demonstrates the importance of
not predigesting the samples during biomarker discovery, thus
allowing the discovery of novel proteolytically generated protein
fragments that may carry diagnostic and mechanistic information."
Despite improvements in prenatal care, preterm birth occurs in
nearly 12% of births in the United States and recent studies
suggest that IAI is implicated as a major cause. Preterm births are
responsible for 80% of neonatal deaths not caused by congenital
defects. The signs and symptoms of IAI are variable, and most
existing diagnostic methods for IAI have poor sensitivity and
specificity for early detection of IAI, or require amniocentesis,
an invasive procedure. Early detection of IAI would open a window
for therapeutic intervention with antibiotics or anti-inflammatory
agents. The study reported in JAMA utilized SELDI to generate a
protein profile from the amniotic fluid of primates with IAI and
discovered overexpression of several clusters of biomarkers. These
clusters were present as early as 12 hours after infection,
indicating that they could be used for early detection. One of
these biomarkers was present in the amniotic fluid of all 11 women
with intraamniotic inflammation who delivered pre-term, in 2/11
women without intra-amniotic inflammation who delivered pre-term,
and in none of the women who delivered at term. Analysis of the
overexpressed cluster of proteins indicates the possibility of a
basic intrauterine immune response to infection since one set of
proteins (the calgranulins) are expressed by macrophages and by
epithelial cells in acutely inflamed tissues. The second
polypeptide from the cluster is a unique fragment of insulin-like
growth factor binding protein-1 (IGFBP-1), indicating a potential
protease-related mechanism in response to infection. The study also
demonstrated that these markers could be detected in serum,
suggesting that an early detection, non-invasive test could be
developed. About Ciphergen Ciphergen's Biosystems Division
develops, manufactures and markets a family of ProteinChip(R)
Systems and services for clinical, research, and process proteomics
applications, as well as a broad range of bioseparations media for
protein purification and large scale production. ProteinChip
Systems enable protein discovery, characterization, identification
and assay development to provide researchers with predictive,
multi-marker assay capabilities and a better understanding of
biological function at the protein level. Ciphergen's Diagnostics
Division is dedicated to the discovery of protein biomarkers and
panels of biomarkers and their development into protein molecular
diagnostic tests that improve patient care; and to providing
collaborative R&D services through its Biomarker Discovery
Center(R) laboratories for biomarker discovery for new diagnostic
tests as well as pharmacoproteomic services for improved drug
toxicology, efficacy and theranostic assays. Additional information
about Ciphergen can be found at http://www.ciphergen.com/. Safe
Harbor Statement Note Regarding 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 biomarkers discovered by Ciphergen that may prove useful
as a diagnostic test for IAI, the use of ProteinChip technology to
discover useful protein biomarkers that can act as novel drug
targets or disease markers, develop and commercialize clinical
diagnostics that improve patient care, the ability to provide
services that lead to improved toxicology assays and diagnostic
assays, and statements regarding our Diagnostics Division. Actual
results may differ materially from those projected in such
forward-looking statements due to various factors, including the
possibility that biomarkers described in the JAMA paper or
discovered in other programs may fail to validate in larger studies
as either providing useful disease mechanism insights or as
accurate diagnostics, the ProteinChip technology's ability to
validate and/or develop protein biomarkers as novel drug targets,
diagnostic or toxicology assays, and the Company's ability to
successfully commercialize such tests. Investors should consult
Ciphergen's filings with the Securities and Exchange Commission,
including its Form 10-Q dated May 10, 2004 and amended May 20,
2004, for further information regarding these and other risks of
the Company's business. NOTE: Ciphergen, ProteinChip, Biomarker
Discovery Center and BioSepra are registered trademarks of
Ciphergen Biosystems, Inc. DATASOURCE: Ciphergen Biosystems, Inc.
CONTACT: Sue Carruthers, Investor Relations of Ciphergen
Biosystems, Inc., +1-510-505 2297 Web site:
http://www.ciphergen.com/
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