Biosite(R) Announces FDA Clearance To Market Triage(R) TOX Drug Screen

Main Category: Neurology / Neuroscience
Article Date: 16 Jul 2006 - 0:00 PDT

email to a friend   printer friendly   opinions  

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.

Biosite Incorporated
http://www.biosite.com/

• Additional
• References
• Citations