Medtox gets FDA approval to market Sure-Screen, a lower detection level drug test

By E. Janene Geiss

Philadelphia, Nov. 2 - Medtox Scientific, Inc. announced Wednesday that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its Sure-Screen drugs-of-abuse point-of-collection test device.

Sure-Screen is intended to provide significantly lower detection levels for eight commonly abused drugs, according to a company news release.

Current tests provide detection levels that have been established by the Substance Abuse and Mental Health Services Administration, a federal agency regulating work place drug testing required by federal law, company officials said.

Those detection levels are generally meant to deter drug abuse and minimize litigation related to employee drug screening, but don't necessarily detect all usage.

Medtox officials said they believe there is a demand for much lower detection levels in certain markets that are interested in "zero tolerance." Those markets include probation and parole, drug rehabilitation, hospital emergency departments, physician office clinics, laboratories and corporate clients wanting lower detection levels for pre-employment testing.

According to Medtox officials, clinical data showed that Sure-Screen will provide lower detection levels on marijuana, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamines and MDMA-Ecstasy by an average of about 50%.

Company officials said they are unaware of any existing FDA cleared point-of-collection test devices with this broad panel and low detection levels.

Medtox, headquartered in St. Paul, Minn., is a provider of specialized laboratory testing services and on-site/point-of-collection devices.

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