SAN DIEGO, July 13 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE) today announced it has signed an exclusive licensing agreement
with Cincinnati Children's Hospital Medical Center and Columbia University for
the use of neutrophil gelatinase-associated lipocalin (NGAL), a biomarker that
may assist clinicians to quickly and accurately identify acute renal failure
within hours rather than days, in diagnostic, monitoring and prognostic
applications.
Under the collaboration, Biosite will make antibodies to NGAL using its
proprietary antibody development process, which combines immunization of mice
and phage display technology to generate highly diverse libraries of
Omniclonal(R) antibodies with high affinity and low cross-reactivity. The
immunoassay for NGAL will then be tested on blood samples to assess
commercialization potential. The financial terms of the agreement were not
disclosed.
Acute renal failure remains a common and critical clinical entity
affecting five percent of all hospitalized patients and 30 to 50 percent of
those in the intensive care unit. It is associated with various medical
problems, treatments, and procedures. Despite advances in medical care, acute
renal failure still carries a significant mortality rate(i). When acute renal
failure is observed in the intensive care unit complicated with other
non-renal organ dysfunction, the associated mortality rate is 50 to
70 percent(ii).
In a recent study, published in the April 1, 2005 issue of The
Lancet(iii), concentrations of NGAL were "strikingly raised" in the urine and
serum of children with acute renal failure after cardiopulmonary bypass.
Noting that acute renal failure occurs in up to four in every 10 patients
undergoing cardiac surgery, Dr. Devarajan, Cincinnati Children's Hospital
Medical Center, Ohio, and colleagues tested whether NGAL could act as an early
biomarker for renal injury after cardiothoracic surgery.
Devarajan and his team studied NGAL expression in blood and urine samples
from 71 children undergoing cardiopulmonary bypass using western blots and
enzyme-linked immunosorbent assay (ELISA). The current gold standard in
diagnosing renal failure (serum creatinine measurement) leads to a diagnosis
one to three days after the initial injury, but by testing for high
concentrations of NGAL, Dr. Devarajan and colleagues at Cincinnati Children's
found they could get definitive test results within hours.
"Our results indicate that NGAL is not only a powerful immediate early
biomarker for acute renal injury, preceding any increase in serum creatinine
by one to three days, but is also a valid discriminatory marker for the entire
duration of the study," wrote the researchers.
"The results from this study appear promising, so we are looking forward
to examining NGAL further," said Gunars Valkirs, Ph.D., senior vice president
Biosite Discovery. "Acute renal failure is a common clinical disorder still
associated with a poor prognosis, and where rapid diagnosis could play a key
role in better patient outcomes."
About Cincinnati Children's Hospital
Cincinnati Children's Hospital Medical Center is a 423-bed institution
devoted to bringing the world the joy of healthier kids. Cincinnati
Children's is dedicated to transforming the way health care is delivered by
providing care that is timely, efficient, effective, family-centered,
equitable and safe. It ranks third nationally among all pediatric centers in
research grants from the National Institutes of Health. The Cincinnati
Children's vision is to be the leader in improving child health. Additional
information can be found at http://www.cincinnatichildrens.org.
About Biosite Incorporated
Biosite Incorporated is a leading bio-medical company commercializing
proteomics discoveries for the advancement of medical diagnosis. The
Company's products contribute to improvements in medical care by aiding
physicians in the diagnosis of critical diseases and health conditions.
Biosite's Triage(R) rapid diagnostics are used in approximately 50 percent of
U.S. hospitals and in over 50 international markets. Information on Biosite
can be found at http://www.biosite.com.
Except for the historical information presented herein, matters discussed
in this press release are forward-looking statements that involve risks and
uncertainties that could cause actual results to differ materially from any
future results, performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including but not
limited to statements that are preceded by, followed by, or that include the
words "will"; "believes"; "should"; "intends"; "anticipates"; "plans";
"expects"; "estimates"; or similar statements are forward-looking statements.
Forward looking statements include statements about the potential benefits of
the license agreement between Biosite, Cincinnati Children's Hospital Medical
Center, and Columbia University, Biosite's ability to generate antibody
libraries and evaluate the diagnostic utility of the target, and the clinical
utility of measuring concentrations of NGAL for purposes of diagnosing kidney
failure or other forms of renal failure or for any other diagnostic,
monitoring or prognostic application. Risks that should be considered include
risks and uncertainties regarding the discovery and product development
process generally, risks associated with the introduction of competitive
products from companies with greater capital and resources, uncertainties
around the proprietary nature of the targets subject to the collaboration,
uncertainties relating to clinical trials and the regulatory approval process
for any new potential product, and risks and expenses associated with
litigation, contract disputes, patent conflicts, product recalls,
manufacturing constraints, backlog, delays or inefficiencies, shipment
problems, seasonal customer demand, the timing of significant orders, changes
in reimbursement policies, regulatory changes, competitive pressures on
average selling prices, and the other risks detailed in Biosite's most recent
Annual Report on Form 10-K, as amended, and other SEC filings. Biosite
disclaims, any intent or obligation to update these forward-looking
statements. Copies of Biosite's public disclosure filings are available from
its investor relations department.
Biosite(R), Triage(R) and New Dimensions in Diagnosis(R) are registered
trademarks of Biosite Incorporated. The Company's logo is a trademark of
Biosite Incorporated.
(i) Singri et al, Acute Renal Failure, JAMA Feb 12, 2003 - Vol 289,
No. 6: 747-751
(ii) Mehta et al, Acute renal failure definitions and classification:
time for change?, J Am Soc Nephrol, 14:2178-2187, 2003
(iii) Mishra et al, Neutrophil gelatinase-associated lipocalin (NGAL)
as a biomarker for acute renal injury following cardiac surgery,
Lancet 2005; 365: 1231-1238
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
http://www.cincinnatichildrens.org
Company News On-Call:
http://www.prnewswire.com/comp/116737.html
CONTACT:
Nadine Padilla, VP, Corporate & Investor
Relations of Biosite Incorporated, +1-858-455-4808, ext. 3187,
npadilla@biosite.com; or Amy Reyes of Cincinnati Children's
Hospital Medical Center, +1-513-636-9684, amy.reyes@cchmc.org
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