MEDTOX Scientific Receives FDA 510(k) Clearance for Additional Three Drugs On the PROFILE(r)-V MEDTOXScan(r) Drugs-of-Abuse Test System


ST. PAUL, Minn., July 29, 2009 (GLOBE NEWSWIRE) -- MEDTOX Scientific, Inc. (Nasdaq:MTOX), announced today that on July 24, 2009, it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its PROFILE(r)-V MEDTOXScan(r) Drugs-of-Abuse Test System with three additional drugs -- Oxycodone, Propoxyphene and Tricyclic Anitidepressants.

The total number of drugs detectable on the system is now twelve. The MEDTOXScan(r) READER and expanded panel is the broadest panel with the lowest detection levels available with any FDA cleared reader in the market place.

The PROFILE(r)-V MEDTOXScan(r) Drugs-of-Abuse Test System consists of the PROFILE(r)-V MEDTOXScan(r) Test Devices and the MEDTOXScan(r) Reader. The Test Devices are one-step immunochromatographic tests for the rapid qualitative detection of one or more of the following drug classes and cutoff concentrations in human urine:


 AMP    Amphetamine                   500 ng/mL
 BAR    Barbiturates                  200 ng/mL
 BZO    Benzodiazepines               150 ng/mL
 COC    Cocaine                       150 ng/mL
 MAMP   Methamphetamine               500 ng/mL
 MTD    Methadone                     200 ng/mL
 OPI    Opiates                       100 ng/mL
 PCP    Phencyclidine                  25 ng/mL
 THC    Cannabinoids                   50 ng/mL
 OXY    Oxycodone                     100 ng/mL
 PPX    Propoxyphene                  300 ng/mL
 TCA    Tricyclic Antidepressants     300 ng/mL

The Reader provides accurate, easy-to-use and cost effective testing for drugs-of-abuse. Results are available in 10 minutes for improved turn around time. There is an optional attached bar-code scanner for accurate entry of user ID, patient ID and lot number of the device. Test results will remain on the digital display until cleared by the operator. A printer provides a paper copy of the results for a permanent record. The Reader also has network integration capabilities and enhanced record storage of 1,000 results with improved record management.

The MEDTOXScan(r) Reader includes a Positive QC Test Device, a Negative QC Test Device and a Cleaning Cassette. The Positive and Negative QC Test Devices are intended to detect potential errors associated with the Reader such as a contaminated contact imaging sensor (CIS) and to verify the CIS cleaning procedure using the approved Cleaning Cassette which effectively removes any contamination.

The Test System is intended for professional use in a hospital laboratory setting. Currently MEDTOX has between 300 and 400 hospital clients utilizing MEDTOX's PROFILE(r) visually read cassettes for drugs-of-abuse detection. The new Test System will be marketed not only to those clients, but to the broader hospital market which is estimated in excess of 2,500 hospitals.

MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a provider of high quality specialized laboratory testing services and on-site/point-of-collection testing (POCT) devices. The company also supports customers with complete logistics, data and program management services. 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. MEDTOX develops and manufactures diagnostic devices for quick and economical on-site/point-of-collection analysis for drugs-of-abuse, therapeutic drugs and biological and agricultural toxins and provides employment drug screening and occupational health testing. For more information see www.medtox.com.

The MEDTOX Scientific, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3264



            

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