MEDTOX Scientific Receives FDA 510(k) Clearance for Its New Sure-Screen(R) Device
November 02 2005 - 11:45AM
Business Wire
MEDTOX Scientific, Inc. (AMEX:TOX), announced today that it has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market its Sure-Screen(R) drugs-of-abuse
point-of-collection test (POCT) device. Sure-Screen(R) is a POCT
device intended to provide significantly lower detection levels for
eight commonly abused drugs. Current tests provide detection levels
that have been established by the Substance Abuse and Mental Health
Services Administration (SAMHSA), a Federal agency that regulates
certain workplace drug testing required under Federal law. Those
detection levels have been broadly adopted by both laboratories and
device makers for all drug screening. The SAMHSA established
detection levels are generally intended to deter drug abuse and
minimize litigation related to employment drug screening, but not
necessarily to detect all usage. The Company believes there is a
demand for the much lower detection levels in certain markets that
are interested in "zero tolerance." Specific markets to which
Sure-Screen(R) will be targeted are, probation, parole, drug
rehabilitation, hospital emergency departments, physician office
clinics, laboratories, and corporate clients interested in lower
detection levels for pre-employment testing. In all of these
markets there is value added in reducing the detection level for
abused drugs, and therefore increasing the number of those detected
abusing drugs. Clinical data supports that Sure-Screen(R) will
provide lower detection levels on eight drugs (marijuana, opiates,
cocaine, amphetamines, methadone, benzodiazepines,
methamphetamines, and MDMA-Ecstasy) by an average of approximately
50% each. Sure-Screen(R) creates a significant competitive
advantage, as the Company is currently unaware of any existing FDA
cleared POCT devices with this broad panel and low detection
levels. MEDTOX Scientifics unique structure in owning an ISO
certified medical device manufacturer and a federally certified
drug testing laboratory creates additional competitive advantages
in two ways. First, Sure-Screen(R) is a preliminary on-site screen
that may require further laboratory confirmation. MEDTOX
Laboratories can provide that confirmation in a seamless manner.
Second, there are a limited number of laboratories that are either
willing or capable of confirming the low drug levels that will be
detected by Sure-Screen(R). MEDTOX Scientific, Inc., headquartered
in St. Paul, Minn., is a provider of high quality specialized
laboratory testing services and on-site/point-of-collection (POC)
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.
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