Dade Behring Announces Availability of Emit II Plus Ecstasy

DEERFIELD, Ill.--()--April 15, 2005--Dade Behring (NASDAQ:DADE) today announced that it has received 510K clearance for the Emit(R) II Plus Ecstasy Assay, the company's rapid screening method for use in detecting the presence of ecstasy in human urine. The assay screens urine for the following illegal substances: methylenedioxymethamphetamine (MDMA, or "Ecstasy"), methylenedioxyethylamphetamine (MDEA) and methylenedioxyamphetamine (MDA). It complies with proposed SAMSHA (Substance Abuse and Mental Health Services Administration) and European regulations, and has approved applications for use on the Olympus(R) AU400(TM)/AU600(TM)/AU2700(TM)/AU5400(TM)(a) systems and the Syva(R) 30R Analyzer. Availability on the Viva-E(TM) and V-Twin(R) drug testing systems is expected in April, with other open chemistry systems to follow.

The Emit(R) II Plus Ecstasy Assay, Dade Behring's newest addition to the comprehensive Syva drugs-of-abuse testing (DAT) menu, meets laboratory demand for an Ecstasy-specific test that includes a 500 ng/mL cutoff level to satisfy, in part, the proposed SAMHSA drug testing guidelines.(1) The new assay is intended to be used as a standalone test or in conjunction with the Emit(R) II Plus Amphetamines Assay, which detects MDMA at higher levels than does this new Ecstasy-specific test.

One of several illegal substances known as "club drugs," Ecstasy is used by millions across the country. According to the National Survey on Drug Use and Health (U.S.), more than 10 million people have tried Ecstasy at least once (2002 report)(2), close to one-half million currently use Ecstasy (2003 report), and more than one million tried Ecstasy for the first time between 2001 and 2002 (2003 report).(3) Community-level data reported in 2003 indicate that Ecstasy use is expanding beyond white adolescents to include college students and older individuals of increasingly diverse ethnicity.(4)

Studies have shown that Ecstasy can have serious effects on cardiovascular and mental health, including persistent deficits in mental processing speed and problem solving.(5-7) These indications present a growing demand on laboratories to test for Ecstasy and closely related drugs.

The Emit(R) II Plus Ecstasy Assay is a convenient, ready-to-use liquid assay based on the gold-standard Emit(R) II Plus chemistry. The assay offers laboratories a variety of solutions depending on their needs. It can be used at the 300 ng/mL or 500 ng/mL cutoff level for qualitative or semiquantitative determination. Reagents are offered in two kit sizes to accommodate both low and high-volume laboratories.

"As the leader in drugs-of-abuse testing, we have a responsibility to provide the laboratories with the highest quality assays for the determination of illegal drugs in patients," said Jim Reid-Anderson, Chairman, President and CEO, Dade Behring. "The use of illegal drugs is a serious concern worldwide. Providing the laboratories with another assay that can accurately determine the use of illegal drugs will allow physicians to determine the best treatment for their patients."

With 2004 revenues of nearly $1.6 billion, Dade Behring is the world's largest company dedicated solely to clinical diagnostics. It offers a wide range of products, systems and services designed to meet the day-to-day needs of labs, delivering innovative solutions to customers and enhancing the quality of life for patients. Additional company information is available on the internet at www.dadebehring.com.

1. United States Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA-proposed rule changes to the federal workplace drug testing program are documented in the Federal Register (69 FR 19673-19732).

2 ."From the director," National Institute on Drug Abuse (NIDA) Research Report Series, MDMA (Ecstasy) Abuse report, April 2004. Available at http://www.drugabuse.gov/ResearchReports/MDMA/; accessed February 9, 2005.

3. Highlights of findings: "Illicit Drug Use" and "Trends in Initiation & Substance Use (Incidence)," 2003 National Survey on Drug Use & Health (NSDUH). Office of Applied Studies, SAMHSA, U.S. Department of Health and Human Services. Available at http://www.oas.samhsa.gov/nhsda/2k3nsduh/2k3Overview.htm#ch1; accessed February 9, 2005.

4. From Community Epidemiology Workgroup (CEWG), reported in June 2003. NIDA Research Report Series, MDMA (Ecstasy) Abuse report, April 2004. Available at http://www.drugabuse.gov/ResearchReports/MDMA/MDMA3.html#who); accessed February 9, 2005.

5. Stocker, Steven. Overall teen drug use stays level, use of MDMA and steroids increases. NIDA Notes 15(1), March 2000. Available at http://www.drugabuse.gov/NIDA_Notes/NNVol15N1/Overall.html; accessed February 9, 2005.

6."From the director," NIDA Research Report Series, MDMA (Ecstasy) Abuse report, April 2004. Available at http://www.drugabuse.gov/NIDA_Notes/NNVol15N1/Overall.html; accessed February 9, 2005.

7. Eisner, Robin. Study suggests cognitive deficits in MDMA-only drug abusers. NIDA Notes, Research Findings 19(5), January 2005. Available at http://www.drugabuse.gov/NIDA_notes/NNvol19N5/Study.html; accessed February 9, 2005. For more information on the study, see Halpern, J.H., et al. Residual neuropsychological effects of illicit 3,4- methylenedioxymethamphetamine (MDMA) in individuals with minimal exposure to other drugs. Drug and Alcohol Dependence 75(2):135-147, 2004.

(a) Olympus(R) AU400(TM)/AU600(TM)/AU2700(TM)/AU5400(TM) are trademarks of Olympus Corporation.

Contacts

Dade Behring
Deirdra Dougherty, 302-631-6872

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Contacts

Dade Behring
Deirdra Dougherty, 302-631-6872