SAN DIEGO, July 13 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE), a research-based provider of novel, rapid medical
diagnostics, today announced it has received U.S. Food and Drug
Administration (FDA) clearance to add methadone to its Triage(R) TOX Drug
Screen. The addition of methadone expands the Triage TOX Drug Screen menu
to cover 10 drug classes, all of which can be accurately and simultaneously
detected within approximately 15 minutes. In 2004, there were nearly 2
million drug-related emergency department visits in the United States, of
which more than 30,000 visits were estimated to be associated with
methadone use or abuse(1).
"Many drugs, such as methadone, can dangerously interact with other
medications, which can put patients at risk if the substances in their body
are not accurately identified in a timely manner," said Norman Paradis,
M.D., Biosite's vice president, clinical and medical affairs. "The Triage
TOX Drug Screen is a rapid and easy-to-interpret device that may allow
physicians to make quicker treatment decisions."
Methadone is a medication affecting the central nervous system that is
used by clinics and hospitals as a treatment of narcotic withdrawal and
dependence. Methadone relieves withdrawal symptoms from heroin, morphine
and other opioid drugs and reduces an addict's opiate craving(2).
With this FDA clearance, Biosite will offer the Triage TOX Drug Screen
with analytes covering 10 major classes of drugs for the qualitative
determination of acetaminophen/paracetamol, amphetamines, methamphetamines,
barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine,
THC and tricyclic antidepressants.
Shipments of the Triage TOX Drug Screen are expected to commence in the
second half of 2006. The tests will be available in countries
internationally upon approval by the local regulatory agencies.
About Biosite(R) 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 more than 50 percent of
U.S. hospitals and in more than 60 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 Triage TOX Drug Screen, and the
commencement of marketing, education and sales of these new products. Risks
and uncertainties include risks regarding the discovery and product
development process generally, risks associated with the commencement of
manufacturing the Triage TOX Drug Screen on a commercial scale and risks
that Triage TOX Drug Screen may not be commercially successful. Other risks
and uncertainties that may impact the Company's business generally include
risks associated with the introduction of competitive products from
companies with greater capital and resources, expansion or development of a
direct sales effort in domestic and international markets, manufacturing
constraints, backlog, delays or inefficiencies, shipment problems,
regulatory changes and the other risks detailed in the Company's most
recent Annual Report on Form 10-K and other SEC filings. The Company
disclaims, however, any intent or obligation to update these
forward-looking statements. Copies of the Company's public disclosure
filings are available from the 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.
(1) Substance Abuse and Mental Health Services Administration, Office of
Applied Studies. Drug Abuse Warning Network, 2004: National
Estimates of Drug Related Emergency Department Visits. DAWN Series
D-28, DHHS Publication No. (SMA) 06-4143, Rockville, MD, 2006.
(2) Office of National Drug Control Policy. Drug Policy Information
Clearinghouse, April 2000.
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com/
http://www.prnewswire.com/comp/116737.html/
CONTACT:
Nadine Padilla, VP, Corporate & Investor
Relations, +1-858-805-2820, npadilla@biosite.com, or Media, Susan
Schotthoefer, Sr. Corporate Communications Specialist,
+1-858-805-2804, sschott@biosite.com, both of Biosite
Incorporated
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