New Analyte Broadens Testing Spectrum for Drug Screen Products
SAN DIEGO, March 2 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE), a research-based provider of novel, rapid medical diagnostics,
today announced that the U.S. Food and Drug Administration (FDA) has granted
the Company clearance to market the Triage(R) TOX Drug Screen with
Acetaminophen (APAP), the first drug screen to include a rapid, point-of-care
test for the qualitative detection of acetaminophen in urine. Overdose from
acetaminophen is the leading cause for calls to U.S. Poison Control Centers
(over 100,000 per year(1)). In the United States, acetaminophen overdose is
estimated to represent five percent, or 275,000, of the 5.2 million total
toxic exposures annually, and nearly 10 percent of all toxic pharmaceutical
exposures annually (275,000 out of 2.9 million)(2).
"According to the National Academy of Clinical Biochemistry guidelines(3),
every patient suspected of intentional drug ingestion should be screened for
acetaminophen in one hour or less," said Ken Buechler, Ph.D., president and
chief scientific officer. "Because the Triage TOX Drug Screen uses the Triage
MeterPlus platform, which produces results in approximately 15 minutes at the
point-of-care, we believe it can improve turnaround time for acetaminophen
screening."
Acetaminophen is one of the most widely used analgesics in the world and
is found in more than 100 common over-the-counter and prescription products.
In 2003, more than 144 million prescriptions were written in the United States
for drugs that contain acetaminophen(4). When used according to labeling
instructions, acetaminophen has an excellent safety profile, however,
acetaminophen toxicity may occur after intentional overdose or acute ingestion
of approximately 150 to 250 milligrams of acetaminophen per kilogram of
bodyweight(5), the equivalent of 15 to 28 extra strength tablets for a
155-pound person.
"In cases of overdose, symptoms may be subtle and clinicians may not
always suspect acetaminophen poisoning," said Julie Doyle, M.D., Biosite's
medical education director. "A rapid, point-of-care test to detect the
presence of acetaminophen can help clinicians make treatment decisions
quickly."
Biosite's tests can detect the presence of acetaminophen in urine as soon
as 30 minutes after the ingestion of a therapeutic dosage of extra strength
acetaminophen tablets in adults. Symptoms of overdose such as nausea,
vomiting and abdominal pain, may not appear for more than 24 hours after
ingestion. Liver damage and even death may occur if the antidote
N-Acetylcysteine (known as NAC or MUCOMYST(R)) is not administered within
eight hours after ingestion(5).
With this FDA clearance, Biosite will offer the Triage TOX Drug Screens in
three different combinations of analytes to cover the eight major classes of
drugs, as follows:
* Triage TOX Drug Screen APAP & PCP for the qualitative determination of
acetaminophen, phencyclidine, amphetamines, methamphetamines,
barbiturates, benzodiazepines, cocaine, opiates and tricyclic
antidepressants.
* Triage TOX Drug Screen APAP & THC for the qualitative determination of
acetaminophen, marijuana, amphetamines, methamphetamines,
barbiturates, benzodiazepines, cocaine, opiates and tricyclic
antidepressants.
* Triage TOX Drug Screen PCP & THC for the qualitative determination of
phencyclidine, marijuana, amphetamines, methamphetimines,
barbiturates, benzodiazepines, cocaine, opiates and tricyclic
antidepressants.
Shipments of the Triage TOX Drug Screen products with acetaminophen are
expected to commence in April 2005. The tests will be available in
English-speaking countries worldwide, including the United States, the United
Kingdom, Ireland, Australia, New Zealand, Hong Kong, South Africa and the
Caribbean. The tests will be available in other countries upon approval by
the local regulatory agencies.
About Biosite(R) Incorporated
A leader in the drive to advance diagnosis, Biosite Incorporated is a
research-based company dedicated to the discovery and development of novel
protein-based diagnostic tests that improve a physician's ability to diagnose
debilitating and life-threatening diseases. Through combined expertise in
diagnostic discovery and commercialization, the Company is able to access
potential markers of disease, identify proteins with high diagnostic utility,
develop and commercialize products and educate the medical community about new
diagnostic approaches, thereby benefiting patients. Biosite's Triage(R) rapid
diagnostics are used in approximately 50 percent of U.S. hospitals and in over
50 international countries for toxicology screening and diagnosis of
infectious and cardiovascular disease. 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 products with Acetaminophen, 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 products with Acetaminophen on a commercial scale and
risks that Triage TOX Drug Screen products with Acetaminophen 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, 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 including those detailed in the Company's most recent
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, 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.
MUCOMYST(R) is a registered trademark of Mead Johnson & Company.
(1) Acetaminophen and the U.S. Acute Liver Failure Study: Lowering the
Risks of Hepatic Failure.
Hepatology, Issue 1, July 2004, p. 6- 9
(2) Watson et al. "2003 Annual Report of the American Association of
Poison Control Centers Toxic Exposure Surveillance System."
(3) National Academy of Clinical Biochemistry Laboratory Medicine
Practice Guidelines: Recommendations for the Use of Laboratory Tests
to Support Poisoned Patients Who Present to the Emergency
Department.
(4) Rx List Top 200 for 2003, NDC Health, Inc.
(5) Goldfrank et al. Goldfrank's Toxicologic Emergencies, 6th edition,
1998.
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
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
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