MEDTOX Receives FDA Clearance to Market New ``Ecstasy'' Test - First Rapid Screen With Ecstasy Claim.Business Editors & Health/Medical Writers ST PAUL, Minn.--(BUSINESS WIRE)--June 11, 2001 MEDTOX Scientific, Inc. (AMEX AMEX See: American Stock Exchange :TOX), said today that on June 1, 2001 its MEDTOX Diagnostic subsidiary received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 510(k) marketing clearance to sell its new VERDICT(R)-II METHAMPHETAMINE/MDMA test. The test is a one-step immunochromatographic test for the rapid, qualitative detection of methylenedioxymethamphetamine (MDMA MDMA 3,4-methylenedioxymethamphetamine. MDMA n. 3,4-Methylenedioxymethamphetamine; a mescaline analog. MDMA 3,4 methylenedioxy-methamphetamine. See Ecstasy. also know as "ecstasy" and methamphetamine (MAMP MAMP Macintosh, Apache, Mysql and PHP MAMP Missouri Association of Meat Processors MAMP Merrifield, Alpha-Methoxyphenyl MAMP Mission Area Materiel Plan MAMP Modified Assigned Material Parameter MAMP Material Acquisition Management Plan ) in human urine. The test detects the two drugs at these cut-off concentrations:
MDMA Methylenedioxymethamphetamine 1500 ng/mL
MAMP Methamphetamine 1000 ng/mL
MDMA has been available as a street drug since the 1980's. Its use has escalated in the late 1990's and early 2000's among college students and young adults. MDMA's street names include "ecstasy," "XTC XTC See Ecstasy, MDMA. ," "clarity," "essence," and "Adam." Based on a study funded by The National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is a United States federal-government research institute whose mission is to "lead the Nation in bringing the power of science to bear on drug abuse and addiction. (NIDA NIDA National Institute on Drug Abuse NIDA National Institute of Dramatic Arts (Australia) NIDA Northern Ireland Development Agency (UK) NIDA Northern Ireland Dairy Association ) in 1998, 3.6 percent of 12th graders, 3.3 percent of 10th graders, and 1.8 percent of 8th graders reported they had used MDMA in the past year. NIDA Notes - Facts About MDMA (Ecstasy). According to the Drug Enforcement Administration The Drug Enforcement Administration (DEA) was established in 1973 by President richard m. nixon as part of the Justice Department, thus uniting a number of federal drug agencies that had often worked at cross-purposes. (DEA DEA - Data Encryption Algorithm ), the majority of the drug is being smuggled into the U.S., but it is also produced in illicit laboratories domestically. MDMA produces significant long-term neurochemical neu·ro·chem·is·try n. The study of the chemical composition and processes of the nervous system and the effects of chemicals on it. neu changes after a single administration and selective and permanent brain damage during repetitive use. Recent DEA data indicate that more than 2 million tablets are smuggled into the U.S. each week. The DEA also estimates that within the Newark, New York Newark is a village in Wayne County, New York, U.S., 30 miles (48 km) east by south of Rochester. The population was 9,682 at the 2000 census. The Village of Newark is in the south part of the Town of Arcadia and is in the south of Wayne County. and Jersey Shore corridor more than 750,000 dosage units are being consumed each week. DEA - Drugs of Concern - MDMA (Ecstasy). "Introduction of VERDICT(R)-II METHAMPHETAMINE/MDMA is the latest example of executing on the plan to continue expanding and extending our diagnostic product lines to maintain a leadership position in the market and serve the needs of our clients," said Richard Braun, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "Demand for MEDTOX Diagnostics point-of-screening Profile(R)-II and Verdict(R)-II devices continues to grow and has significant momentum." In the first five months of 1999, 2000 and 2001; 65,000, 288,000 and 685,000 devices shipped; respectively. Since January of 2001, MEDTOX has received six 510(k) clearances on nine new device products and configurations from the FDA, has one application pending and expects to file a number of additional applications for new products and markets in 2001. MEDTOX now has more than 27 product and device configurations targeted at specific markets and customer needs. In addition, the Profile(R)-II ER product, which began shipping in April, continues to receive an excellent early reception. Currently the product is sold through the MEDTOX direct sales force. As previously stated the company is continuing discussions with a select number of major buying groups and a prominent distributor that have expressed strong interest in providing the Profile(R)-II ER product to their client base. MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a provider of high quality specialized laboratory and on-site/ point-of-testing devices. The company also supports customers with complete logistics, data and program management services. MEDTOX develops and manufactures diagnostic devices for quick and economical on-site/ point-of-test analysis for drugs of abuse, therapeutic drugs and agricultural toxins and provides employment drug screening and occupational health testing. MEDTOX is a leader in providing esoteric laboratory testing services to hospitals and laboratories nationwide. This includes both central laboratory and bio-analytical testing for pharmaceutical clinical trials. To be automatically alerted by e-mail about company information, please go to www.corporateir.net/ireye/ir_site.zhtml?ticker=tox&script=1900 and follow the directions on the page. For more information see www.medtox.com. Note: Forward-looking statements contained in this press release are made under the Private Securities Reform Act of 1995. Actual results may differ due to a number of factors including a change in the employment pattern of client companies, the ability of MEDTOX to acquire new business, and changes in the competitive environment. Fuller discussions of factors that may cause such results to differ are identified on page three of the company's 2000 annual report on Form 10-K and incorporated herein by reference. |
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