Biosite Gains Additional Claim for Triage(R) BNP Test

Search Blogs that Mention this News Release
Click this link to view linked Bookmarking Services
Click this link to view linked Blogging Services
Biosite Gains Additional Claim for Triage(R) BNP Test
 Heart Failure Test Can Now Be Used for Risk Stratification of Heart Failure
                                   Patients

    SAN DIEGO, Sept. 28 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE) today announced that the U.S. Food and Drug Administration has
cleared a new indication for its Triage(R) BNP Test.  This test can now be
used to help physicians assess the risk of mortality or rehospitalization in
heart failure patients.  Previously, the test was cleared as an aid in the
diagnosis of congestive heart failure (also known as heart failure),
assessment of disease severity and in the risk stratification of patients with
acute coronary syndromes (ACS).
    "Recent studies have shown that when a heart failure patient is admitted
and/or discharged, measurements of BNP provide prognostic information about
the patient's risk for death or re-hospitalization," said Ken Buechler, Ph.D.,
Biosite's president and chief scientific officer.  "We are pleased that FDA
has cleared this additional claim for our Triage BNP Test."
    A systematic review of studies investigating B-type natriuretic peptide
(BNP) for prognostic utility in patients with heart failure concluded that
every 100 pg/mL increase in BNP concentration was associated with a 35 percent
increase in the relative risk of death, and that admitted heart failure
patients whose BNP values did not decrease over the course of their treatment
are at a particularly high risk of death or a cardiovascular event.(1)  The
authors also found that higher BNP concentrations in asymptomatic patients
were prognostic for future death or cardiovascular events.  Patients with
higher BNP concentrations (> 1,000 pg/mL and > 480 pg/mL, respectively) had a
significantly higher risk of all-cause, cardiac, and pump-failure death and
cardiac-related readmissions.(2)  Studies of admitted heart failure patients
receiving treatment have found that patients who did not experience death or
readmission within 30 days or six months exhibited a decrease in BNP
concentrations from admission to discharge, while patients whose BNP
concentration did not decrease from admission to discharge were at
significantly higher risk for adverse events.(3, 4)  Admitted heart failure
patients with pre-discharge BNP concentrations of 350-700 pg/mL had a hazard
ratio of 5.1 for death or readmission for heart failure within six months and
patients with a pre-discharge BNP concentration greater than 700 pg/mL had a
hazard ratio of 15.2 for the same endpoint compared to patients with a
pre-discharge BNP concentration less than 350 pg/mL.(5)  Taken together, these
studies indicate that higher BNP concentrations or the lack of a decrease in
the BNP concentration from hospital admission to discharge indicate an
increased risk of hospitalization or death in patients with heart failure.

    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 more than 50 international markets.  Information on
Biosite can be found at http://www.biosite.com.

    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.

     1.  Doust, J.A., Pietrzak, E., Dobson, A., and Glasziou, P., How well
         does B-type natriuretic peptide predict death and cardiac events in
         patients with heart failure: systematic review.  BMJ 330:625-633,
         2005.
     2.  Vrtovec, B., Delgado, R., Zewail, A., Thomas, C.D., Richartz, B.M.,
         and Radovancevic, B.  Prolonged QTc interval and high B-type
         natriuretic peptide levels together predict mortality in patients
         with advanced heart failure.  Circulation 107:1764-1769, 2003.
     3.  Cheng, V., Kazanegra, r., Garcia, A., Lenert, L., Krishnaswamy, P.,
         Gardetto, N., Clopton, P., and Maisel, A., A rapid bedside test for
         B-type natriuretic peptide predicts treatment outcomes in patients
         admitted for decompensated heart failure: a pilot study.  J. Am.
         Coll. Cardiol.  37:386-391, 2001.
     4.  Bettencourt, P., Ferreira, S., Azevedo, A., and Ferreira, A.,
         Preliminary data on the potential usefulness of B-type natriuretic
         peptide levels in predicting outcome after hospital discharge in
         patients with heart failure.  Am. J. Med. 2002 113:215-219, 2002.
     5.  Logeart, D., Thabut, G., Jourdain, P., Chavelas, C., Beyne, P.,
         Beauvais, F., Bouvier, E., and Solal, A.C., Predischarge B-type
         natriuretic peptide assay for identifying patients at high risk of
         re-admission after decompensated heart failure.  J. Am. Coll.
         Cardiol. 43:635-41, 2004.
SOURCE Biosite Incorporated
http://www.biosite.com
Company News On-Call:
http://www.prnewswire.com/comp/116737.html
CONTACT:
Nadine Padilla, Vice President, Corporate &
Investor Relations of Biosite Incorporated, +1-858-805-2820,
npadilla@biosite.com